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Completed

NCT Number: NCT01867086

Salvage Ovarian FANG™ Vaccine + Carboplatinum

This is a Phase II study of Vigil™ autologous tumor cell vaccine integrated with carboplatinum. All patients will have Vigil™ prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking. Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2/3 hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection, once every 3 weeks.

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Key information

Conditions

Stage III Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Stage IV Ovarian Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mary Crowley Cancer Research Centers

Dallas, Texas, 75230, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed papillary serous or endometrioid ovarian cancer.
  • Previous randomization to Gradalis, Inc. protocol CL-PTL 105; observation arm (Group B) or or patients with vaccine prepared for CL-PTL 105 but did not otherwise qualify.
  • Recurrent cisplatinum-sensitive disease (defined as the appearance of any measurable or evaluable lesion or as asymptomatic CA-125 levels greater than 100 u/mL at two consecutive measurements after a 6 month period after platinum treatment.
  • Successful manufacturing of 4 vials of Vigil™ vaccine.
  • Recovered from all clinically relevant toxicities related to prior therapies.
  • ECOG PS 0-2 prior to Vigil™ vaccine administration.
  • Normal organ and marrow function as defined below:
  • Absolute granulocyte count ≥ 1,500/mm3
  • Absolute lymphocyte count ≥ 200/mm3
  • Platelets ≥ 100,000/mm3
  • Total bilirubin ≤ 1.5 x ULN
  • AST(SGOT)/ALT(SGPT)/alkaline phosphatase ≤ 2.5 x ULN
  • Creatinine < 1.5 mg/dL
  • Patients must be off all "statin" drugs for ≥ 2 weeks prior to initiation of therapy.
  • Ability to understand and the willingness to sign a written informed protocol specific consent.

Exclusion criteria

  • Surgery involving general anesthesia, chemotherapy, radiotherapy, steroid therapy, or immunotherapy within 4 weeks prior to vaccination. Chemotherapy within 3 weeks prior to vaccination. Steroid therapy within 1 week prior to vaccination.
  • Patient must not have received any other investigational agents within 4 weeks prior to study entry.
  • Patients who require parenteral hydration of nutrition and have evidence of partial bowel obstruction or perforation.
  • Patients with history of brain metastases.
  • Patients with compromised pulmonary disease.
  • Short term (<30 days) concurrent systemic steroids ≤ 0.25 mg/kg prednisone per day (maximum 7.5 mg/day) and bronchodilators (inhaled steroids) are permitted; other steroid regimens and/or immunosuppressives are excluded.
  • Prior splenectomy.
  • Prior malignancy (excluding nonmelanoma carcinomas of the skin and carcinoma in situ cervix) unless in remission for ≥ 2 years.
  • Kaposi's Sarcoma.
  • Patients with peripheral neuropathy ≥2 (paclitaxel).
  • Uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patients with known HIV.
  • Patients with chronic Hepatitis B and C infection.
  • Patients with uncontrolled autoimmune diseases.

Treatment and study plan

Vigil™ Vaccine

Biological

Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.

Other names: bi-shRNA furin and GMCSF Augmented Autologous Tumor Cell Vaccine, formerly known as FANG™

Carboplatinum

Drug

Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.

Carboplatinum and Taxol

Drug

Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.

Primary outcomes

  1. Time to Progression (TTP)

    Time frame: 24 months

    Time to progression (TTP) will be determined following Carboplatinum integrated with Vigil vaccine in patients failing standard of care in study CL-PTL 105 or in those not otherwise qualifying after vaccine production. This will be measured from the treatment start date (date of first dose) to either the date the patient is first recorded as having disease recurrence (even if the patient went off treatment because of toxicity), or the date of death if the patient dies due to any causes before progression.

  2. Response Rate

    Time frame: Up to 12 months

    Response will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline.

Secondary outcomes

  1. Immune Analysis in Blood

    Time frame: Baseline, End of Treatment (30 days after last dose) up to 12 months

    To determine if subjects will have a positive (defined as >10 ELISPOTS from baseline) immune response to Vigil. Blood was collected to compare ELISPOT results from baseline until 30 days after last dose.

Other outcomes

  1. Number of Alive Subjects

    Time frame: 24 months

    Survival status of patients after treatment will be determined.

Sponsors and collaborators

Lead sponsor

Gradalis, Inc.

Industry

Registry information

Official study title

Phase II Trial of Adjuvant Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine (FANG™) Integrated With Chemotherapy for Patients With Recurrent Cisplatinum Sensitive Ovarian Cancer Participating in Study CL-PTL 105

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2013
Registry last updated
Jun 19, 2018

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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