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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy and Colony- Stimulating Factor in Treating Patients With Metastatic Colorectal Cancer  Monoclonal Antibody Therapy and Colony- Stimulating Factor in Treating Patients With Metastatic Colorectal Cancer
Monoclonal Antibody Therapy and Colony- Stimulating Factor in Treating Patients With Metastatic Colorectal Cancer
For Condition: recurrent colon cancer,recurrent rectal cancer
Status: Completed
Sponsor(s): George Washington University ,
Synopsis: 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 .
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed carcinoma of the colon or rectum with radiologically confirmed metastases or clinically confirmed incurability; No hepatic or CNS metastases Progression following fluorouracil (5-FU) alone or with a modulator (e.g., leucovorin, PALA, levamisole, interferon) - Measurable disease outside prior radiotherapy fields The following are not considered measurable: Pleural effusion or ascites; Osteoblastic lesions or evidence of disease on bone scan alone; Progressive irradiated lesions alone; Bone marrow involvement Brain metastases; Malignant hepatomegaly by physical exam alone; Chemical markers (e.g., CEA) --Prior/Concurrent Therapy-- - Biologic therapy: No prior mouse-based vaccines or monoclonal antibodies - Chemotherapy: At least 2 weeks since prior 5-FU or at least 1 week past the AGC nadir, whichever is later; No other prior chemotherapy except irinotecan - Endocrine therapy: Not specified - Radiotherapy: At least 6 months since radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Zubrod 0-2 - Life expectancy: At least 16 weeks - Hematopoietic: Absolute neutrophil count at least 1,800/mm3; Platelet count at least 125,000/mm3 - Hepatic: Bilirubin no greater than 1.5 mg/dL - Renal: Creatinine no greater than 1.5 mg/dL - Other: No concurrent infection; Afebrile for at least 3 days prior to treatment unless fever due to tumor; No known HIV infection; No other medical condition that precludes protocol participation; No second malignancy within 5 years except: Nonmelanomatous skin cancer; Curatively treated in situ cervical carcinoma; No pregnant or nursing women; Negative pregnancy test required of fertile women; Effective contraception required of fertile women - Blood/body fluid analyses within 7 days prior to registration; Imaging/exams for tumor measurement within 21 days prior to registration
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JamesAhlgren, Study Chair, George Washington University
George Washington University Hospital
Washington D.C., District of Columbia, 20037
United States
Additional Information:
Study ID Numbers: CDR0000064248; GWCC-5095,NCI-V95-0686
Study Start Date: July 1995
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002664
Other Recurrent Rectal Cancer Studies:
1. Cetuximab and Best Supportive Care Compared With Best Supportive Care Alone in Treating Patients With Metastatic Epidermal Growth Factor Receptor-Positive Colorectal Cancer
2. Combination Chemotherapy in Treating Patients With Recurrent or Metastatic Colorectal Cancer
3. SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer
4. Erlotinib in Treating Patients With Recurrent or Metastatic Colorectal Cancer
5. Combination Chemotherapy in Treating Patients With Advanced Colorectal Cancer
Related Studies:
Other recurrent rectal cancer Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Monoclonal Antibody Therapy and Colony- Stimulating Factor in Treating Patients With Metastatic Colorectal Cancer
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