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Completed

NCT Number: NCT00041639

Safety Study of 90Y-hMN14 to Treat Pancreatic Cancer

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of pancreatic cancer.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medizinische Fakultaet der Charité Berlin, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

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

Disease Characteristics:

  • Patients with a documented histologic or cytologic diagnosis of a pancreatic malignancy
  • Patients with recurrent, advanced and/or metastatic disease, who have either failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
  • Patients with at least one identified (confirmed) and measureable tumor site.

Prior/Concurrent Therapy:

  • Surgery: Patients are excluded if they have had major surgery either during or within four weeks prior to study entry.
  • Chemotherapy: Patients must have failed standard therapy or are not eligible for any alternate therapies of higher therapeutic priority.
  • Biologic Therapy: Patients who have received a chimeric, CDR-grafted (humanized), or human IgG will be eligible provided pre-study evaluations demonstrate no significant reactivity with hMN14 IgG (i.e., HAHA)
  • Radiotherapy: No prior radiotherapy within four weeks of study entry. No prior external beam irradiation to a field that includes more than 30% of the red marrow. No prior radiation to maximal tolerable levels for any critical organ (e.g., 3,000 cGy for the liver; 2,000 cGy for the lungs and kidneys).
  • Other: Any experimental therapy (i.e., drugs, biologics, procedures) for the primary malignancy, either during or within four weeks prior to study entry.

Patient Characteristics/Inclusion Criteria:

  • Performance Status: Patients with a Karnofsky performance status > 70% (or equivalent, ECOG 0-1) and an expected survival rate of at least 3 months
  • Hematopoietic: Hemoglobin > 10g/dL; WBC > 3000 per mm3; Granulocyte count > 1500 per mm3; platelet count > 100,000 per mm3
  • Hepatic: Total bilirubin < 1.5 times the institutional upper limit of normal (IULN); AST or ALT < 2 X IULN
  • Renal: Creatinine < IULN
  • Cardiovascular: Patients with LVEF >/= 50% by required MUGA/2D-ECHO study
  • Pulmonary: Patients with DF and FEV1 >/= 60 % by required Pulmonary Function Tests
  • Gastrointestinal:Patients with severe anorexia or other related symptomology are excluded
  • Central Nervous System: Patient with known metastatic disease to the CNS are excluded
  • Other: Patients who have had a prior imaging study with a murine antibody may be included. Patients agreeing to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be preformed on each premenopausal female of childbearing potential immediately prior to entry into the study. Patients able to understand and give written informed consent.

Treatment and study plan

hMN14 (labetuzumab)

Drug

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase I/II Study of Radioimmunotherapy With 90Y-Humanized MN-14 IgG Administered as a Single Dose to Patients With Refractory Advanced/Metastatic Pancreatic Carcinoma

Important dates

Study start
2000
Study completion
2003
First posted
Jul 15, 2002
Registry last updated
Aug 19, 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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