Safety Study of 90Y-hMN14 to Treat Colorectal Cancer Patients With Limited Residual Disease After Surgery

Phase 1

Terminated

• Conditions: Colorectal Neoplasms

• Registration Number: NCT00041691
• Lead Sponsor: Gilead Sciences

Brief Summary

The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of residual colorectal cancer following recent surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2002-07-12
• Study First Submitted QC: 2002-07-12
• Study First Posted: 2002-07-15
• Status Verified: 2003-01
• Last Update Submitted: 2021-08-12
• Last Update Posted: 2021-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Performance Status: Patients with Karnofsky performance status > 70%
• Hematopoietic: ANC >/= 1.5 x 10/L; Hemoglobin >/= 10 g/dL; Platelets >/= 100 x 10/L
• Renal: Serum Creatinine </= 1.5 x ULN
• Hepatic: Serum Bilirubin </= 1.5 ULN; AST and ALT </= 2.5 x ULN; Alk Phosphatase </= 2.5 x ULN
• Cardiovascular: Patients with LVEF >/= 50% by required MUGA/2D-ECHO tests
• Pulmonary: Patients with DF and FEV1 >/= 60% by required Pulmonary Function Tests
• Central Nervous System: Patients with known metastatic disease to the CNS are excluded.
• Other: 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 study. Patients must understand and give written informed consent.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (2)

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States

Virginia Mason Medical Center; 🇺🇸 Seattle, Washington, United States