Vaccine Therapy in Treating Patients With Stage IV Cutaneous Melanoma

Phase 1

Completed

• Conditions: Melanoma (Skin)

• Registration Number: NCT00074230
• Lead Sponsor: University Hospital Erlangen

Brief Summary

RATIONALE: Vaccines made from a person's dendritic cells and antigens may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy using autologous dendritic cells with antigens in treating patients who have stage IV cutaneous melanoma.

Detailed Description

OBJECTIVES:

Primary

* Determine the safety and tolerability of vaccination with autologous monocyte-derived dendritic cells (DC) transfected with RNAs encoding Melan-A, MAGE-3, and survivin antigens in patients with stage IV cutaneous melanoma.

* Determine whether tumor antigen-specific T-cell responses are induced in patients treated with this vaccine.

* Determine whether simultaneous loading of DC with keyhole limpet hemocyanin (KLH) significantly enhances induction of the Melan-A, MAGE-3, and survivin antigens in these patients.

Secondary

* Determine clinical antitumor activity (e.g., objective tumor response, time to tumor progression, progression-free interval, and overall survival) in patients treated with this vaccine.

OUTLINE: This is an open-label, nonrandomized study.

* Phase I: Beginning 9-11 days before vaccination, patients undergo leukapheresis for collection of peripheral blood mononuclear cells (PBMCs). PBMCs are processed for the generation of dendritic cells (DC) to be used for vaccinations. PBMCs are transfected with RNAs encoding for Melan-A, MAGE-3, and survivin antigens. DC are pulsed with keyhole limpet hemocyanin (KLH) for some patients.

Patients receive antigen-pulsed (with or without KLH) DC vaccination subcutaneously (SC) on days 1, 15, 43, and 71 in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may proceed to the phase II portion of the study.

* Phase II: Patients undergo leukapheresis as in phase I on days 102, 354, and 690. Patients receive up to 6 additional booster vaccinations SC as in phase I on days 127, 185, 269, 356, 521, and 692.

Patients are followed for 10 years.

PROJECTED ACCRUAL: A total of 8-30 patients will be accrued for this study within 6-12 months.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2003-12-10
• Study First Submitted QC: 2003-12-10
• Study First Posted: 2003-12-11
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall survival as assessed by clinical staging (CT scan, positron emission tomography [PET]) every 3 months	3 months
Safety and tolerability at every visit	3 months

Secondary Outcome Measures

Name	Time	Method
Time to progression as assessed by clinical staging (CT scan, PET) every 3 months	3 months
Duration of response as assessed by clinical staging (CT scan, PET) every 3 months	3 months
Induction of antigen-specific immune responses as assessed by elispot and tetramer staining at every visit	3 months
Objective tumor response as assessed by clinical staging (CT scan, PET) every 3 months	3 months

Trial Locations

Locations (1)

Dermatologische Klinik mit Poliklinik - Universitaetsklinikum Erlangen; 🇩🇪 Erlangen, Germany