Colorectal Cancer Clinical Trial
Official title:
PHASE II STUDY OF MONOCLONAL ANTIBODY 17-1A WITH GM-CSF IN TREATMENT OF 5-FU RESISTANT COLORECTAL CANCER
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.
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.
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