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Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer

NCT ID: NCT00017537

Last Updated: 2013-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2000-03-31

Study Completion Date

2005-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer Gastric Cancer Lung Cancer Ovarian Cancer Unspecified Adult Solid Tumor, Protocol Specific

Keywords

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose #1

dose #1 administered

Group Type EXPERIMENTAL

MVF-HER-2(628-647)-CRL 1005 vaccine

Intervention Type BIOLOGICAL

Dose #2

dose #2 administered

Group Type EXPERIMENTAL

MVF-HER-2(628-647)-CRL 1005 vaccine

Intervention Type BIOLOGICAL

Dose #3

Dose #3 administered

Group Type EXPERIMENTAL

MVF-HER-2(628-647)-CRL 1005 vaccine

Intervention Type BIOLOGICAL

Dose #4

Dose #4 administered

Group Type EXPERIMENTAL

MVF-HER-2(628-647)-CRL 1005 vaccine

Intervention Type BIOLOGICAL

Dose #5

Administered dose #5

Group Type EXPERIMENTAL

MVF-HER-2(628-647)-CRL 1005 vaccine

Intervention Type BIOLOGICAL

Interventions

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MVF-HER-2(628-647)-CRL 1005 vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre L. Triozzi, MD

Role: STUDY_CHAIR

University of Alabama at Birmingham

Other Identifiers

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UAB-0020

Identifier Type: -

Identifier Source: secondary_id

NCI-G01-1955

Identifier Type: -

Identifier Source: secondary_id

CDR0000068700

Identifier Type: -

Identifier Source: org_study_id