Vaccine Therapy in Treating Patients With Metastatic Cancer

Phase 1

Completed

• Conditions: Lung Cancer; Melanoma; Ovarian Sarcoma; Eye Cancer; Adult Soft Tissue Sarcoma; Colorectal Cancer; Breast Cancer; Uterine Sarcoma; Bone Cancer; Colon Cancer

• Registration Number: NCT00020267
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

RATIONALE: Vaccines made from a peptide may make the body build an immune response and kill tumor cells.

PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic cancer that has not responded to previous therapy.

Detailed Description

OBJECTIVES: I. Determine the toxicity profile of MAGE-12 peptide vaccine in patients with refractory metastatic cancer that expresses MAGE-12 antigen.

II. Determine whether an immunologic response, as measured by an in vitro sensitization assay, can be obtained after administration of this regimen in these patients.

III. Determine a frequency of administration for this regimen based on immunologic response in these patients.

IV. Determine other immunologic parameters in these patients treated with this regimen.

V. Determine the clinical response rate in these patients treated with this regimen.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to disease (metastatic cutaneous melanoma vs other tumor types). Patients are randomized to one of two treatment arms.

Arm I: Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant subcutaneously (SC) weekly for 4 doses.

Arm II: Patients receive MAGE-12 peptide vaccine emulsified in Montanide ISA-51 adjuvant SC once every 3 weeks for 4 doses.

Patients with progressive disease may receive interleukin-2 IV over 15 minutes every 8 hours, beginning on the day after each immunization and continuing for up to 4 days. Patients achieving stable disease or a mixed, partial, or complete response continue on vaccine therapy alone for up to 24 total doses.

Patients are followed at 3 weeks.

PROJECTED ACCRUAL:

A total of 26-56 patients (13-28 per treatment arm) will be accrued for this study within 1 year.

Study Timeline

• Study Start: 2000-07
• Study First Submitted: 2007-03-02
• Study First Submitted QC: 2007-03-02
• Study First Posted: 2007-03-06
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Surgery Branch; 🇺🇸 Bethesda, Maryland, United States