Vaccine Therapy in Treating Patients With Metastatic Melanoma

Melanoma (Skin) Clinical Trial

Official title:

A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00334776
• Other study ID #: 10M-03-1
• Secondary ID: LAC-USC-10M-03-1
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2006
• Last updated: May 19, 2014
• Start date: October 2003
• Est. completion date: June 2005

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill melanoma cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with metastatic melanoma.

Description:

OBJECTIVES:

Primary

• Determine clinical response in HLA-A *0201-positive patients with metastatic melanoma treated with an intradermally administered vaccine comprising autologous dendritic cells pulsed with MART-1, gp100, and tyrosinase peptides and matured with a cytokine cocktail.

Secondary

• Determine immunologic response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo apheresis to collect dendritic cells (DC). Autologous DC are pulsed ex vivo with tumor antigen peptides derived from MART-1: 26-35 (27L), gp100: 209-217 (210M), and tyrosinase: 368-376 (370D) and matured with a cytokine cocktail comprising interleukin (IL)-4, IL-6, IL-1β, sargramostim (GM-CSF), tumor necrosis factor-α, and prostaglandin E2.

Patients receive 12 intradermal injections of DC vaccine over 30 minutes on days 1, 8, 22, and 36. Treatment repeats every 8 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically until disease progression.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of melanoma

• Metastatic disease

• The following melanoma subtypes are eligible:

• Unresectable, stage III-IV uveal melanoma

• Metastatic mucosal melanoma

• Measurable disease after attempted curative surgical therapy

• Tumor tissue must be available for immunohistochemical staining

• Positive for = 1 of the following peptides:

• MART-1: 26-35 (27L)

• gp100: 209-217 (210M)

• Tyrosinase: 368-376 (370D)

• HLA-A *0201 positive by DNA polymerase chain reaction assay

PATIENT CHARACTERISTICS:

• ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%

• Creatinine = 2.0 mg/dL

• Bilirubin = 2.0 mg/dL

• WBC = 3,000/mm^3

• Platelet count = 75,000/mm^3

• Hemoglobin = 9.0 g/dL

• No major systemic infections

• No coagulation disorders

• No major medical illness of the cardiovascular or respiratory system

• No myocardial infarction within the past 6 months

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No known HIV positivity

• No know positivity for hepatitis B surface antigen or hepatitis C antibody

• No prior uveitis or autoimmune inflammatory eye disease

• No other prior malignancy except cervical carcinoma in situ or basal cell skin cancer unless patient was curatively treated > 5 years ago and has no detectable disease

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No more than 1 prior cytotoxic chemotherapy agent or regimen

• Prior biologic or antiangiogenic therapies allowed

• More than 1 month since prior and no concurrent radiotherapy, chemotherapy, adjuvant therapy, or any other therapy for melanoma

• No prior MART-1: 26-35 (27L), gp100: 209-217 (210M), or tyrosinase: 368-376 (370D) peptides

• No concurrent steroid therapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Melanoma (Skin)
• Uveal Neoplasms

Intervention

Biological:
• MART-1 antigen

• gp100:209-217(210M) peptide vaccine

• therapeutic autologous dendritic cells

• tyrosinase peptide

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival			No
Primary	Progression-free survival			No
Primary	Time to progression			No
Primary	Toxicity			Yes