Vaccine Therapy in Treating Patients With Metastatic Melanoma

University of Southern California

Status and phase

Completed

Phase 2

Conditions

Melanoma (Skin)

Intraocular Melanoma

Treatments

Biological: MART-1 antigen

Biological: tyrosinase peptide

Biological: therapeutic autologous dendritic cells

Biological: gp100:209-217(210M) peptide vaccine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00334776

LAC-USC-10M-03-1

NCI-2009-00050 (Registry Identifier)

10M-03-1

CDR0000480137 (Registry Identifier)

NCI-6262

LAC-USC-033307

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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