Monoclonal Antibody Therapy and Colony- Stimulating Factor in Treating Patients With Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00002664|
Recruitment Status : Withdrawn (No recruitment)
First Posted : May 24, 2004
Last Update Posted : July 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Biological: edrecolomab Biological: sargramostim||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PHASE II STUDY OF MONOCLONAL ANTIBODY 17-1A WITH GM-CSF IN TREATMENT OF 5-FU RESISTANT COLORECTAL CANCER|
|Study Start Date :||July 1995|
|Primary Completion Date :||February 22, 2017|
|Study Completion Date :||February 22, 2017|
|Experimental: Treatment||Biological: edrecolomab Biological: sargramostim|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002664
|United States, District of Columbia|
|George Washington University Hospital|
|Washington, D.C., District of Columbia, United States, 20037|
|Study Chair:||James D. Ahlgren, MD||George Washington University|