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Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00017537
First received: June 6, 2001
Last updated: August 2, 2013
Last verified: November 2012

June 6, 2001
August 2, 2013
March 2000
March 2005   (final data collection date for primary outcome measure)
Determine the optimum biologic dose of MVF-HER-2 (628-647)-CRL 1005 vaccine that will induce snit-HER-2 antibody in patients with metastatic or recurrent cancer [ Time Frame: baseline to 1 year ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00017537 on ClinicalTrials.gov Archive Site
  • Characterize the nature and severity of toxicity of this drug in these patients. [ Time Frame: baseline to 1 year ] [ Designated as safety issue: Yes ]
  • Document any clinical responses to this drug in these patients. [ Time Frame: baseline to 1 year ] [ Designated as safety issue: No ]
Not Provided
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Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
Phase IB Trial of Active Specific Immunotherapy With MVF-HER-2(628-647) and CRL1005 Copolymer Adjuvant in Patients With Metastatic Cancer

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Gastric Cancer
  • Lung Cancer
  • Ovarian Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Biological: MVF-HER-2(628-647)-CRL 1005 vaccine
  • Experimental: Dose #1
    dose #1 administered
    Intervention: Biological: MVF-HER-2(628-647)-CRL 1005 vaccine
  • Experimental: Dose #2
    dose #2 administered
    Intervention: Biological: MVF-HER-2(628-647)-CRL 1005 vaccine
  • Experimental: Dose #3
    Dose #3 administered
    Intervention: Biological: MVF-HER-2(628-647)-CRL 1005 vaccine
  • Experimental: Dose #4
    Dose #4 administered
    Intervention: Biological: MVF-HER-2(628-647)-CRL 1005 vaccine
  • Experimental: Dose #5
    Administered dose #5
    Intervention: Biological: MVF-HER-2(628-647)-CRL 1005 vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2005
March 2005   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00017537
CDR0000068700, UAB-0020, NCI-G01-1955
Yes
University of Alabama at Birmingham
University of Alabama at Birmingham
National Cancer Institute (NCI)
Study Chair: Pierre L. Triozzi, MD University of Alabama at Birmingham
University of Alabama at Birmingham
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP