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PHASE II STUDY OF MONOCLONAL ANTIBODY 17-1A WITH GM-CSF IN TREATMENT OF 5-FU RESISTANT COLORECTAL CANCER


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

PHASE II STUDY OF MONOCLONAL ANTIBODY 17-1A WITH GM-CSF IN TREATMENT OF 5-FU RESISTANT COLORECTAL CANCER


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.

Inclusion 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)

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

James D. Ahlgren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

George Washington University

Authority:

United States: Federal Government

Study ID:

CDR0000064248

NCT ID:

NCT00002664

Start Date:

July 1995

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

Name

Location

George Washington University HospitalWashington, District of Columbia  20037