Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer

Phase 1

Withdrawn

• Conditions: Breast Cancer; Gastric Cancer; Lung Cancer; Ovarian Cancer; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Biological: MVF-HER-2(628-647)-CRL 1005 vaccine

• Registration Number: NCT00017537
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-03
• Study First Submitted: 2001-06-06
• Study First Submitted QC: 2004-01-07
• Study First Posted: 2004-01-08
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2012-11
• Last Update Submitted: 2013-08-02
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose #1	MVF-HER-2(628-647)-CRL 1005 vaccine	dose #1 administered
Dose #2	MVF-HER-2(628-647)-CRL 1005 vaccine	dose #2 administered
Dose #3	MVF-HER-2(628-647)-CRL 1005 vaccine	Dose #3 administered
Dose #4	MVF-HER-2(628-647)-CRL 1005 vaccine	Dose #4 administered
Dose #5	MVF-HER-2(628-647)-CRL 1005 vaccine	Administered dose #5

Primary Outcome Measures

Name	Time	Method
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	baseline to 1 year

Secondary Outcome Measures

Name	Time	Method
Characterize the nature and severity of toxicity of this drug in these patients.	baseline to 1 year
Document any clinical responses to this drug in these patients.	baseline to 1 year