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Phase IB Trial of Active Specific Immunotherapy With MVF-HER-2(628-647) and CRL1005 Copolymer Adjuvant in Patients With Metastatic Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer, Gastric Cancer, Lung Cancer, Ovarian Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Phase IB Trial of Active Specific Immunotherapy With MVF-HER-2(628-647) and CRL1005 Copolymer Adjuvant in Patients With Metastatic Cancer


OBJECTIVES: I. Determine the optimum biologic dose of MVF-HER-2(628-647)-CRL 1005 vaccine
that will induce anti-HER-2 antibody in patients with metastatic or recurrent cancer. II.
Characterize the nature and severity of toxicity of this drug in these patients. III.
Document any clinical responses to this drug in these patients.

OUTLINE: This is a dose-escalation study. Patients receive MVF-HER-2(628-647)-CRL 1005
vaccine intramuscularly on days 1 and 29. Cohorts of 5 patients receive escalating doses of
MVF-HER-2(627-647)-CRL 1005 vaccine until at least 2 of 5 patients experience dose-limiting
toxicity. Patients are followed on days 43 and 57 and every 2 months for at least 1 year.

PROJECTED ACCRUAL: Approximately 5-25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed metastatic and/or recurrent solid tumor,
especially the following: Breast Ovarian Non-small cell lung cancer Gastric adenocarcinoma
No standard therapy available No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 1.5 mg/dL ALT less than 2 times upper limit of normal
No hepatitis A, B, or C Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine
clearance greater than 60 mL/min Cardiovascular: No serious cardiopulmonary disorder No
congestive heart failure No symptomatic coronary artery disease No serious cardiac
arrhythmia Pulmonary: No serious cardiopulmonary disorder No symptomatic chronic
obstructive pulmonary disease Immunologic: Reactive to at least 1 of the following skin
test antigens: Candida, mumps, Trichophyton, intermediate strength PPD, tetanus toxoid No
concurrent disease requiring corticosteroids or other immunosuppressive drugs No
autoimmune disease, including rheumatoid arthritis, systemic lupus erythematosus,
scleroderma, polymyositis-dermatomyositis, or vasculitic syndrome No prior anaphylactic
response to other vaccine No hypersensitivity to MVF-HER-2(628-647) Other: No active HIV
No active infection requiring antibiotic therapy No serious medical disease Not pregnant
or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and
recovered Chemotherapy: At least 4 weeks since prior cytotoxic chemotherapy and recovered
Endocrine therapy: At least 4 weeks since prior hormonal therapy and recovered No
concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy and
recovered Surgery: At least 4 weeks since prior surgery and recovered No prior splenectomy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Pierre L. Triozzi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000068700

NCT ID:

NCT00017537

Start Date:

March 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • Gastric Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • stage IV breast cancer
  • recurrent breast cancer
  • stage IV gastric cancer
  • recurrent gastric cancer
  • recurrent non-small cell lung cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • adenocarcinoma of the stomach
  • stage IV non-small cell lung cancer
  • unspecified adult solid tumor, protocol specific
  • Breast Neoplasms
  • Lung Neoplasms
  • Stomach Neoplasms
  • Ovarian Neoplasms

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