Vaccine Therapy in Treating Patients With Metastatic, Progressive Prostate Cancer

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Biological: NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine

• Registration Number: NCT00616291
• Lead Sponsor: Baylor College of Medicine

Brief Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects of a peptide vaccine in treating patients with metastatic prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the safety and tolerance of NY-ESO-1/LAGE-1 class-I and class-II vaccine administered subcutaneously in patients with androgen-independent metastatic prostate cancer.

Secondary

* Compare the response induced by immunotherapy with a combined class-I and class-II NY-ESO-1/LAGE-1 vaccine to responses obtained to either class I or class II peptides alone.

* Evaluate whether the inclusion of class-II epitopes in a peptide vaccine will result in a better antitumor immune response than class-I epitopes alone.

* Determine antitumor activity by antigen response assays including cytokine elaboration, changes in frequency of peripheral T cells that recognize tumor, and intra/peritumoral cellular infiltrates and cytokine expression in responding and nonresponding metastasis.

OUTLINE: Patients receive NY-ESO-1/LAGE-1 peptide vaccine subcutaneously every other week for 12 weeks in the absence of disease progression or unacceptable toxicity. The initial cohorts of patients are treated with one course of either MHC Class I-binding or MHC Class II-binding peptides. If these Class I or Class II binding peptides are safe individually, subsequent cohorts of patients with appropriate HLA type receive both types of peptides in combination.

After completion of study treatment, patients are followed every 6 months for up to 5 years.

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2008-02-14
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-15
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-05
• Last Update Posted: 2012-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group III	NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine	Combination MHC Class I and II binding peptide at 1000 mcg each
Group I	NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine	MHC Class I binding peptide at 1000 mcg
Group II	NY-ESO-1/LAGE-1 HLA class I/II peptide vaccine	MHC Class II binding peptide at 1000 mcg

Primary Outcome Measures

Name	Time	Method
Tolerability
Toxicity

Secondary Outcome Measures

Name	Time	Method
Immunological response

Trial Locations

Locations (1)

Dan L. Duncan Cancer Center at Baylor College of Medicine; 🇺🇸 Houston, Texas, United States