Monoclonal Antibody Therapy and Colony- Stimulating Factor in Treating Patients With Metastatic Colorectal Cancer

Phase 2

Withdrawn

• Conditions: Colorectal Cancer
• Interventions: Biological: edrecolomab; Biological: sargramostim

• Registration Number: NCT00002664
• Lead Sponsor: James Ahlgren

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors such as G-CSF may increase the number of immune cells found in bone marrow or peripheral blood, and may help a person's immune system kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus G-CSF in treating patients with metastatic colorectal cancer that has not responded to treatment with fluorouracil.

Detailed Description

OBJECTIVES: I. Assess the response rate, duration of response, and survival after treatment with monoclonal antibody 17-1A and granulocyte-macrophage colony stimulating factor in patients with colorectal cancer metastatic to nonhepatic sites and refractory to fluorouracil. II. Describe the toxicities associated with this regimen. III. Assess the quality of life in these patients.

OUTLINE: Biological Response Modifier Therapy. Colorectal antigen 17-1A murine monoclonal antibody, MOAB 17-1A, NSC-377963; Granulocyte-macrophage colony stimulating factor (Immunex), GM-CSF, NSC-613795.

PROJECTED ACCRUAL: There will be 30 evaluable patients accrued into this study over approximately 1 year.

Study Timeline

• Study Start: 1995-07
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2004-05-21
• Study First Posted: 2004-05-24
• Primary Completion: 2017-02-22
• Study Completion: 2017-02-22
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-10
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	edrecolomab	-
Treatment	sargramostim	-

Trial Locations

Locations (1)

George Washington University Hospital; 🇺🇸 Washington, D.C., District of Columbia, United States