Vaccine Therapy in Treating Patients With Metastatic Melanoma

Sponsor

University of Southern California (Other)

Overall Status

Completed

CT.gov ID

NCT00334776

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Intraocular Melanoma Melanoma (Skin)	Biological: MART-1 antigen Biological: gp100:209-217(210M) peptide vaccine Biological: therapeutic autologous dendritic cells Biological: tyrosinase peptide	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Oct 1, 2003

Actual Primary Completion Date :

Jun 1, 2005

Actual Study Completion Date :

Jun 1, 2005

Outcome Measures

Primary Outcome Measures

Overall survival []
Progression-free survival []
Time to progression []
Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California	United States	90089-9181
2	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942