Safety and Efficacy Study of Different Doses of 90Y-hPAM4 Combined With Gemcitabine in Pancreatic Cancer

Phase 1

Completed

• Conditions: Pancreatic Cancer
• Interventions: Biological: IMMU-107 (hPAM4)

• Registration Number: NCT00603863
• Lead Sponsor: Gilead Sciences

Brief Summary

This is a study to test whether different doses of 90Y-hPAM4 are safe to give in combination with gemcitabine in patients with previously untreated pancreatic cancer.

Detailed Description

Patients receive a 4-week treatment cycle with once-weekly 30-minute gemcitabine infusions beginning one week prior to the first 90Y-hPAM4dose and continuing during the 3 consecutive weeks over which once weekly 90Y-hPAM4 doses are given. Depending on toxicity, patient cohorts will receive one of several possible 90Y and gemcitabine dose combinations. Post-treatment evaluations conducted until instituting another 90YhPAM4 treatment cycle, maintenance gemcitabine or for a maximum period of 12 weeks.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-29
• Primary Completion: 2013-07
• Study Completion: 2013-12
• Status Verified: 2014-01
• Disposition First Submitted: 2021-08-12
• Disposition First Submitted QC: 2021-08-12
• Last Update Submitted: 2021-08-12
• Disposition First Posted: 2021-08-16
• Last Update Posted: 2021-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Male or female patients, >18 years of age, who are able to understand and give written informed consent.
• Histologically or cytologically confirmed pancreatic adenocarcinoma.
• Stage III (locally advanced, unresectable) or Stage IV (metastatic) disease, including patients who underwent surgery but had incomplete resections.
• Treatment naïve (no prior chemotherapy, radiotherapy or investigational agents for pancreatic cancer)
• Karnofsky performance status > 70 % (Appendix A).
• Expected survival > 3 months.
• At least 4 weeks beyond major surgery and recovered from all acute toxicities
• At least 2 weeks beyond corticosteroids, except low doses (i.e., 20 mg/day of prednisone or equivalent) to treat nausea or other illness such as rheumatoid arthritis
• Adequate hematology without ongoing transfusional support (hemoglobin > 11 g/dL, ANC > 2,000 per mm3, platelets > 150,000 per mm3)
• Adequate renal and hepatic function (creatinine and bilirubin ≤ 1.5 X IULN, AST and ALT ≤ 2.0 X IULN)
• Otherwise, all toxicity at study entry <Grade 1 by NCI CTC v3.0.

Exclusion Criteria

• Women who are pregnant or lactating.

  • Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
  • Known metastatic disease to the central nervous system.
  • Presence of bulky disease (defined as any single mass >10 cm in its greatest dimension)
  • Patients with >Grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
  • Prior radiation dose >3,000 cGy to the liver, >2,000 cGy to lungs and kidneys or prior external beam irradiation to a field that includes more than 30% of the red marrow.
  • Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are not excluded, but patients with other prior malignancies must have had at least a 5-year disease free interval.
  • Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
  • Known history of active coronary artery disease, unstable angina, myocardial infarction, or congestive heart failure present within 6 months or cardiac arrhythmia requiring anti-arrhythmia therapy.
  • Known history of active COPD, or other moderate-to-severe respiratory illness present within 6 months.
  • Known autoimmune disease or presence of autoimmune phenomena (except rheumatoid arthritis requiring only low dose maintenance corticosteroids).
  • Infection requiring intravenous antibiotic use within 1 week.
  • Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
multiple dose levels	IMMU-107 (hPAM4)	1 of 3 different dose levels of 90Y-hPAM4 given once weekly for 3 weeks along with 4 weekly doses of gemcitabine.

Primary Outcome Measures

Name	Time	Method
safety will be evaluated based upon physical examinations, hematology and chemistry laboratory testing as well as toxicity	over 12 weeks

Secondary Outcome Measures

Name	Time	Method
Efficacy and Clinical benefit measures such as quality of life, pain assessments, etc.	over 5 years

Trial Locations

Locations (11)

Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Sylvester Comprehensive Cancer Center; 🇺🇸 Miami, Florida, United States

New York Presbyterian Hospital/Weill Cornell Medical Center; 🇺🇸 New York, New York, United States

Mt. Sinai Medical Center; 🇺🇸 New York, New York, United States

Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States

Herbert Werthem College of Medicine/Jackson North Medical Center; 🇺🇸 Miami, Florida, United States

Goshen Cancer Center; 🇺🇸 Goshen, Indiana, United States

Thomas Jefferson University Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Moffit Cancer Center; 🇺🇸 Tampa, Florida, United States

Winship Cancer Institute/Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States