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

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: February 2001

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 Intervention Phase
Colorectal Cancer Biological: edrecolomab Biological: sargramostim Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: July 1995
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

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

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

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Please refer to this study by its identifier: NCT00002664

United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Study Chair: James D. Ahlgren, MD George Washington University
  More Information Identifier: NCT00002664     History of Changes
Other Study ID Numbers: CDR0000064248
Study First Received: November 1, 1999
Last Updated: February 6, 2009

Keywords provided by National Cancer Institute (NCI):
recurrent colon cancer
recurrent rectal cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on June 23, 2017