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NCT Number: NCT01053013

Open-Label Phase 2 Efficacy Trial of Cancer Macrobeads in Patients With Treatment-Resistant Pancreatic/Colorectal Cancer

This is a clinical research study of an investigational (FDA BB-IND 10091) treatment for patients with pancreatic cancer (all stages) and advanced colorectal cancer that no longer responds to standard therapies.

The treatment is being evaluated for its effect on tumor growth. It consists of the placement (implantation) of small beads that contain mouse renal adenocarcinoma cells (RENCA macrobeads). The cells in the macrobeads produce substances that have been shown to slow or stop the growth of tumors in experimental animals and veterinary patients. It has been tested in 31 human subjects with different types of cancers in a Phase I safety trial. Phase II studies in patients with colorectal, pancreatic or prostate cancers are in progress.

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Key information

Conditions

Pancreatic Adenocarcinoma Non-resectable Colorectal Cancer Metastatic Pancreatic Adenocarcinoma Metastatic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Weill Cornell Medical Center / The Rogosin Institute

New York, 10021, United States

About this study

This is an open-label Phase 2 clinical trial. The study will have a duration of 12 months and involve a potential total of four macrobead implants for each enrolled patient, with the implants being no less than three months apart.

The RENCA macrobeads are implanted intraperitoneally, using laparoscopic surgical procedures. The macrobeads remain permanently within the peritoneal cavity, even if patients withdraw from the study and/or begin new therapy (e.g. chemotherapy). After the formal phase of the trial is completed, subjects will be followed for life.

The intent of this Phase 2 trial is to assess efficacy, safety, and tolerability of RENCA macrobeads. Screening occurs within 28 days prior to first implantation. Enrolled patients are treated with a dose of 8 RENCA macrobeads per kilogram of body weight and observed for a minimum of 3 months prior to the next implantation. A maximum of 4 implantation procedures is possible. Day 0 is the day of implantation.

Prior to the start of the study, the Investigators ensured that the protocol and any attendant documentation were approved, in writing, by the Institutional Review Board. The study was conducted in compliance with the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice Guidelines (E6 [R1]) for conducting, recording, and reporting studies, as well as for archiving essential documents.

The Investigators, the Medical Monitor of the sponsor, and the Data Safety Monitoring Board were responsible for monitoring safety parameters collected in the study. They, collectively, provided oversight and monitoring of the safety of the participants in the study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically confirmed adenocarcinoma of the pancreas, colon or rectum.
  • Radiographic evidence of metastatic cancer of the colon or rectum.
  • Pancreatic cancer that is unresectable or already metastatic, or colorectal cancer that has failed available approved treatment modalities.
  • For pancreatic cancer patients, prior chemotherapy is not required; for colon and rectal cancer patients must have failed available chemotherapy/targeted regimens. There were no limits to the number of prior chemotherapeutic regimens.
  • The patient had evidence of progressive disease defined as at least one of the following:
  • Progressive measurable disease using conventional solid tumor criteria.
  • Increasing tumor markers and/or activity on positron emission tomography / standard uptake value (PET/SUV) measurement.
  • All clinically significant toxic effects (excluding alopecia) of prior surgery, radiotherapy, or hormonal therapy were resolved to ≤ Grade 1 based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0 (NCI CTCAE v.3.0) with the exception of neuropathy, which was resolved to ≤ Grade 2.
  • Performance status (ECOG PS) 0-2.
  • Adequate hematologic function, minimum requirements:
  • absolute neutrophil count (ANC) ≥ 1500/mL
  • hemoglobin ≥ 9 g/dL
  • platelets ≥ 100,000/mL
  • Adequate hepatic function, defined as follows:
  • bilirubin ≤ 1.5 times the upper limit of normal (ULN)
  • aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times the ULN, or ≤ 5 times the ULN if liver metastases are present
  • Adequate renal function, defined as serum creatinine ≤ 2.0 mg/dL.
  • Adequate coagulation function, defined as follows:
  • an international normalized ratio (INR) ≤ 1.5
  • a partial thromboplastin time (PTT) ≤ 5 seconds above the ULN, unless on anti-coagulant therapy
  • patients receiving full-dose anticoagulation therapy were eligible provided they met all other criteria, were on a stable dose or anticoagulant therapy or low molecular weight heparin (and if on warfarin had a therapeutic INR between 2-3)
  • Life expectancy of at least 6 weeks.
  • For females of childbearing potential, a negative pregnancy test.
  • Agrees to contraceptive use (barrier method) while on study, if sexually active.
  • Provided signed informed consent.

Exclusion criteria

  • Any condition presenting an unacceptably high anesthetic or surgical risk, based on current anesthesia/general surgery standards.
  • Positive test for HIV, hepatitis B, C, or E.
  • Cognitive impairment such as to preclude informed consent.
  • Hypersensitivity reaction that, in the opinion of the investigators posed an increased risk of an allergy to the macrobeads, particularly any known allergy to murine antigens or body tissues.
  • Surgical treatment or chemotherapy within three weeks of scheduled macrobead implantation or within four weeks of bevacizumab (or similar drugs), or radiation therapy within four weeks of scheduled macrobead implantation.
  • Investigational medication(s)/therapies for respective tumor within one month of baseline evaluation.
  • Inadequate hematologic function, defined as follows:
  • ANC < 1500/mL
  • hemoglobin < 9 g/dL
  • platelets < 100,000/mL
  • Inadequate hepatic function, defined as follows:
  • bilirubin > 1.5 times the ULN
  • AST and ALT > 3 times the ULN or > 5 times the ULN, if liver metastases present
  • Inadequate renal function, defined as serum creatinine > 2.0 mg/dL.
  • Inadequate coagulation function, defined as follows:
  • INR > 1.5
  • PTT > 5 seconds (unless on anti-coagulant therapy)
  • Hepatic blood flow abnormalities, portal vein hypertension and thrombosis, and/or large-volume ascites.
  • Concurrent cancer of any other type except skin cancer (excluding melanoma).
  • Ongoing or active infection, congestive heart failure, unstable angina, serious cardiac arrhythmias, psychiatric illness, difficult social situations not permitting reliable participation, active bleeding.
  • As a result of the medical history, examination, or blood testing, the investigator considers the patient unfit for the study.

Treatment and study plan

RENCA macrobeads

Biological

Other names: mouse renal adenocarcinoma (RENCA) macrobeads, macrobead, cancer macrobead

Primary outcomes

  1. Overall Survival - Based on Most Recent Scan

    Time frame: From date of the most recent scan (disease progression) prior to the first macrobead implantation; assessed up to 32 months.

    The primary efficacy outcome is post-implantation all-cause mortality, where time to death is defined as the time from the most recent scan prior to first implantation (time of origin, To) to death from any cause.

Secondary outcomes

  1. Overall Survival - Based on 1st Implant

    Time frame: From date of the first RENCA macrobead implant; assessed up to 32 months.

    The secondary efficacy objective was to evaluate overall survival calculated using the time from first RENCA macrobead implantation to death from any cause.

  2. Overall Survival - Based on Stage IV Disease Diagnosis

    Time frame: From date of Stage IV disease diagnosis up to 126 months; up to 32 months from first RENCA macrobead implant.

    The secondary efficacy objective was to evaluate overall survival calculated using the time from Stage IV disease diagnosis to death from any cause.

Other outcomes

  1. Necrosis Comparison of Tumors Using PET-CT Scan

    Time frame: Baseline vs. Day 90 post-Implant 1

    Tumors were assessed by positron emission tomography (PET)-CT scan at baseline and day 90 following the first RENCA macrobead implantation. The use of [13]F-fluorodeoxyglucose (FDG) uptake for the detection of lesions >1 cm in diameter allowed evaluation of metabolic activity. Decreases in FDG uptake were indicative of metabolic suppression of the tumor. The use of PET-CT scanning indicated anatomical localization, approximate size/volume of primary tumor and metastatic lesion(s), and assessment of metabolic activity of the tumor (as an indicator of metabolic health and necrosis).

    Disease state is reported as a function of Tumor measurement divided by SUVmax. Changes were assessed between day 90 post RENCA macrobead implant and baseline values. Patients with no change = stable; patients with decreased values = decreased/necrosis, and patients with increased values = increased.

  2. Tumor Marker Response of mCRC Participants

    Time frame: Change from baseline up to and including day 30 post-Implant 1

    Tumor markers included serum carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9), and were assessed on all participants with mCRC at baseline and at subsequent evaluation points to further assess tumor response to RENCA macrobead implantation. A tumor marker response was defined as a greater than or equal to 20% decrease in one or both of CEA or CA 19-9.

  3. Tumor Marker Response of Pancreatic Cancer Participants

    Time frame: Change from baseline up to and including day 30 post-Implant 1.

    Tumor markers included serum carcinoembryonic antigen (CEA) and cancer antigen 19-9 (CA 19-9), and were assessed on all participants with pancreatic cancer at baseline and at subsequent evaluation points to further assess tumor response to RENCA macrobead implantation. A tumor marker response was defined as a greater than or equal to 20% decrease in one or both of CEA or CA 19-9.

  4. C-reactive Protein Levels in mCRC Participants

    Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

    C-reactive protein (CRP) is one of three inflammatory markers assessed during this study. CRP levels were assessed as a marker of systemic inflammatory processes.

  5. C-Reactive Protein Levels in Pancreatic Cancer Participants

    Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

    C-reactive protein (CRP) is one of three inflammatory markers assessed during this study. CRP levels were assessed as a marker of systemic inflammatory processes.

  6. Erythrocyte Sedimentation Rate in mCRC Participants

    Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

    Erythrocyte sedimentation rate (ESR) is one of three inflammatory markers assessed during this study. ESR was assessed as a marker of systemic inflammatory processes.

  7. Erythrocyte Sedimentation Rate in Pancreatic Cancer Participants

    Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

    Erythrocyte sedimentation rate (ESR) is one of three inflammatory markers assessed during this study. ESR was assessed as a marker of systemic inflammatory processes.

  8. Cancer Antigen 125 Levels in mCRC Participants

    Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

    Cancer Antigen 125 (CA 125) is one of three inflammatory markers assessed during this study. CA 125 was used to monitor more localized intra-abdominal/peritoneal inflammatory processes related to the placement of the RENCA macrobeads or, in some cases, the intraperitoneal spread of tumor.

  9. Cancer Antigen 125 Levels in Pancreatic Cancer Participants

    Time frame: Day 0, 14, 30, 60 post-Implant 1 and Day 0, 14, 30, 60 post-Implant 2 (when applicable).

    Cancer Antigen 125 (CA 125) is one of three inflammatory markers assessed during this study. CA 125 was used to monitor more localized intra-abdominal/peritoneal inflammatory processes related to the placement of the RENCA macrobeads or, in some cases, the intraperitoneal spread of tumor.

  10. Performance Status (ECOG Score) of mCRC Participants

    Time frame: Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2

    The Eastern Cooperative Oncology Group (ECOG) performance scale is a 5-point scale, where 0 denotes perfect health and 5 is death. It is used by clinicians to assess disease progression and how the disease is affecting the daily living abilities of the patient. The ECOG Performance Status scores are defined as follows:

    0: Fully active, able to carry on all pre-disease activities without restriction.

    • Restricted in physical strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light house work, office work).
    • Ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours.
    • Capable of only limited self-care, confined to bed or chair 50% or more of waking hours.
    • Completely disabled, cannot carry on any self-care, totally confined to bed or chair.
    • Death

  11. Performance Status (ECOG Score) of Pancreatic Cancer Participants

    Time frame: Baseline; Day 14, 30, 60 post-Implant; Day 14, 30, 60 post-Implant 2

    The Eastern Cooperative Oncology Group (ECOG) performance scale is a 5-point scale, where 0 denotes perfect health and 5 is death. It is used by clinicians to assess disease progression and how the disease is affecting the daily living abilities of the patient. The ECOG Performance Status scores are defined as follows:

    0: Fully active, able to carry on all pre-disease activities without restriction.

    • Restricted in physical strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light house work, office work).
    • Ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours.
    • Capable of only limited self-care, confined to bed or chair 50% or more of waking hours.
    • Completely disabled, cannot carry on any self-care, totally confined to bed or chair.
    • Death

  12. Activities of Daily Living (KPS Score) of mCRC Participants

    Time frame: Baseline; Day 14, 30, 60 Post-Implant 1; Day 14, 30, 60 post-Implant 2

    Karnofsky Performance Status (KPS) is a self-rated scale that measures the participant's ability to perform daily functions, ranging from 0 ("dead") to 100 ("normal, no complaints, no evidence of disease). Karnofsky scores are defined as follows:

    100: Normal; no complaints; no evidence of disease 90: Able to carry on normal activity with effort, minor sign or symptoms of disease 80: Normal activity with effort; some sign or symptoms of disease 70: Cares for self; unable to carry on normal activity or do active work 60: Requires occasional assistance, but is able to care for most personal needs 50: Requires considerable assistance and frequent medical care 40: Disabled; requires special care and assistance 30: Severely disabled; hospitalization is indicated, although death is not imminent 20: Very sick; hospitalization/active support treatment is necessary 10: Moribund; fatal processes progressively worsening 0: Dead

  13. Activities of Daily Living (KPS Score) for Pancreatic Cancer Participants

    Time frame: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2

    Karnofsky Performance Status (KPS) is a self-rated scale that measures the participant's ability to perform daily functions, ranging from 0 ("dead") to 100 ("normal, no complaints, no evidence of disease). Karnofsky scores are defined as follows:

    100: Normal; no complaints; no evidence of disease 90: Able to carry on normal activity with effort, minor sign or symptoms of disease 80: Normal activity with effort; some sign or symptoms of disease 70: Cares for self; unable to carry on normal activity or do active work 60: Requires occasional assistance, but is able to care for most personal needs 50: Requires considerable assistance and frequent medical care 40: Disabled; requires special care and assistance 30: Severely disabled; hospitalization is indicated, although death is not imminent 20: Very sick; hospitalization/active support treatment is necessary 10: Moribund; fatal processes progressively worsening 0: Dead

  14. Global Health Status of mCRC Participants

    Time frame: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales, three symptom scales, a global health status score, and six single items.

    The Global Health Status is assessed from 2 of the 30 questions (Question 29 and 30), whose response score ranges on a 7 point scale. The score for physical function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor) and the maximum value is 100 (best outcome, excellent). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  15. Global Health Status of Pancreatic Cancer Participants

    Time frame: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales, three symptom scales, a global health status score, and six single items.

    The Global Health Status is assessed from 2 of the 30 questions (Question 29 and 30), whose response score ranges on a 7 point scale. The score for physical function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor) and the maximum value is 100 (best outcome, excellent). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  16. Physical Function of mCRC Participants

    Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including physical function), three symptom scales, a global health status score, and six single items.

    Physical Function is assessed from 5 of the 30 questions (Questions 1-5), whose response score ranges on a 4 point scale. The score for physical function is calculated based on the average score from these 5 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  17. Physical Function of Pancreatic Cancer Participants

    Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including physical function), three symptom scales, a global health status score, and six single items.

    Physical Function is assessed from 5 of the 30 questions (Questions 1-5), whose response score ranges on a 4 point scale. The score for physical function is calculated based on the average score from these 5 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  18. Role Function of mCRC Participants

    Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including role function), three symptom scales, a global health status score, and six single items.

    Role Function is assessed from 2 of the 30 questions (Questions 6 and 7), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  19. Role Function of Pancreatic Cancer Participants

    Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including role function), three symptom scales, a global health status score, and six single items.

    Role Function is assessed from 2 of the 30 questions (Questions 6 and 7), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  20. Emotional Function of mCRC Participants

    Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including emotional function), three symptom scales, a global health status score, and six single items.

    Emotional Function is assessed from 4 of the 30 questions (Questions 21-24), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 4 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  21. Emotional Function of Pancreatic Cancer Participants

    Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including emotional function), three symptom scales, a global health status score, and six single items.

    Emotional Function is assessed from 4 of the 30 questions (Questions 21-24), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 4 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  22. Cognitive Function of mCRC Participants

    Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including cognitive function), three symptom scales, a global health status score, and six single items.

    Cognitive Function is assessed from 2 of the 30 questions (Question 20 and 25), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  23. Cognitive Function of Pancreatic Cancer Participants

    Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including cognitive function), three symptom scales, a global health status score, and six single items.

    Cognitive Function is assessed from 2 of the 30 questions (Question 20 and 25), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  24. Social Function of mCRC Participants

    Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including social function), three symptom scales, a global health status score, and six single items.

    Social Function is assessed from 2 of the 30 questions (Question 26 and 27), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  25. Social Function of Pancreatic Cancer Participants

    Time frame: Baseline; Day 30, 60 post-Implant 1; Day 30, 60 post-Implant 2

    The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30, version 3.0) consists of 30 questions which pertain to: five functional scales (including social function), three symptom scales, a global health status score, and six single items.

    Social Function is assessed from 2 of the 30 questions (Question 26 and 27), whose response score ranges on a 4 point scale. The score for role function is calculated based on the average score from these 2 questions. A linear transformation is used to standardize these responses. Using this linear transformation, the minimum value is 0 (worst outcome, poor functionality) and the maximum value is 100 (best outcome, better functionality). Therefore, increasing values indicate better outcome and decreasing values indicate worse outcome.

  26. Pain Assessment of mCRC Participants

    Time frame: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2

    Participants were asked to rate their pain on a discrete scale (from 0 = "no pain" to 10 "worst pain imaginable, unbearable"). The worst pain at each time point was used in the analysis.

  27. Pain Assessment of Pancreatic Cancer Participants

    Time frame: Baseline; Day 14, 30, 60 post-Implant 1; Day 14, 30, 60 post-Implant 2

    Participants were asked to rate their pain on a discrete scale (from 0 = "no pain" to 10 "worst pain imaginable, unbearable"). The worst pain at each time point was used in the analysis.

Sponsors and collaborators

Lead sponsor

The Rogosin Institute

Other

Collaborators

  • Vital Systems Inc.

Registry information

Official study title

An Open-Label Phase 2 Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose-Agarose Macrobeads in the Treatment of Patients With Treatment-Resistant, Metastatic Pancreatic or Colorectal Cancer

Acronym: Macrobead

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jan 21, 2010
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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