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Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
This study is ongoing, but not recruiting participants.
First Received: June 6, 2001   Last Updated: May 30, 2009   History of Changes
Sponsor: University of Alabama at Birmingham
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00017537
  Purpose

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 Intervention Phase
Breast Cancer
Gastric Cancer
Lung Cancer
Ovarian Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Biological: MVF-HER-2(628-647)-CRL 1005 vaccine
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Phase IB Trial of Active Specific Immunotherapy With MVF-HER-2(628-647) and CRL1005 Copolymer Adjuvant in Patients With Metastatic Cancer

Resource links provided by NLM:


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

Study Start Date: March 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00017537

Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Study Chair: Pierre L. Triozzi, MD University of Alabama at Birmingham
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000068700, UAB-0020, NCI-G01-1955
Study First Received: June 6, 2001
Last Updated: May 30, 2009
ClinicalTrials.gov Identifier: NCT00017537     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Thoracic Neoplasms
Gastrointestinal Diseases
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Genital Diseases, Female
Neoplasms by Site
Stomach Diseases
Respiratory Tract Diseases
Lung Neoplasms
Stomach Neoplasms
Breast Diseases
Endocrine Gland Neoplasms
Respiratory Tract Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Skin Diseases
Genital Neoplasms, Female
Breast Neoplasms
Endocrine System Diseases
Adnexal Diseases
Neoplasms
Digestive System Diseases
Lung Diseases
Gastrointestinal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009