RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic or recurrent cancer.

Condition	Treatment or Intervention	Phase
recurrent ovarian epithelial cancer stage IV non-small cell lung cancer unspecified adult solid tumor, protocol specific recurrent non-small cell lung cancer stage IV ovarian epithelial cancer recurrent gastric cancer stage IV breast cancer recurrent breast cancer stage IV gastric cancer adenocarcinoma of the stomach	Procedure: biological response modifier therapy  Vaccine: non-tumor cell derivative vaccine  Procedure: vaccine therapy  Procedure: protein tyrosine kinase inhibitor therapy  Procedure: enzyme inhibitor therapy  Drug: MVF-HER-2(628-647)-CRL 1005 vaccine	Phase I

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--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

--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

Study chairs or principal investigators

Pierre Lorenzo Triozzi,  Study Chair,  UAB Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068700; UAB-0020; NCI-G01-1955
Record last reviewed:  January 2004
Last Updated:  October 13, 2004
Record first received:  June 6, 2001
ClinicalTrials.gov Identifier:  NCT00017537
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08