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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer  Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
For Condition: recurrent ovarian epithelial cancer,recurrent non-small cell lung cancer,recurrent gastric cancer,stage 4 breast cancer,stage 4 ovarian epithelial cancer,adenocarcinoma of the stomach,stage 4 gastric cancer,stage 4 non-small cell lung cancer,recurrent breast cancer,unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , UAB Comprehensive Cancer Center
Synopsis: 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PierreTriozzi, Study Chair, UAB Comprehensive Cancer Center
Additional Information:
Study ID Numbers: CDR0000068700; UAB-0020,NCI-G01-1955
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017537
Other Stage 4 Breast Cancer Studies:
1. Trastuzumab in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer That Overexpresses HER2
2. Suramin and Either Docetaxel or Gemcitabine in Treating Patients With Stage IIIB or Stage IV Platinum-Refractory Non-Small Cell Lung Cancer
3. Acridine Carboxamide in Treating Patients With Advanced Non-small Cell Lung Cancer
4. Intravenous Interleukin-4 PE38KDEL Cytotoxin in Treating Patients With Recurrent or Metastatic Kidney Cancer, Non-Small Cell Lung Cancer, or Breast Cancer
5. Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced Non-Small Cell Lung Cancer
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Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
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