Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma

A Phase II Trial of a MART-1/gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Treated With CD40 Ligand/Gamma Interferon With Subcutaneous IL-2 for Patients With Metastatic Melanoma

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00006113

Enrollment

Registered

2003-01-27

Start date

1999-06-30

Completion date

2006-04-30

Last updated

2014-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma (Skin)

Keywords

stage III melanoma, stage IV melanoma, recurrent melanoma

Brief summary

RATIONALE: Vaccines made from melanoma cells may make the body build an immune response to kill tumor cells. Biological therapies such as interferon gamma and interleukin-2 use different ways to stimulate the immune system and stop cancer cells from growing. Combining vaccine therapy with biological therapy may kill more tumor cells. PURPOSE: This phase II trial is studying giving vaccine therapy together with interferon gamma and interleukin-2 in treating patients with stage III or stage IV melanoma.

Detailed description

OBJECTIVES: * Determine the clinical response rate and immune response in HLA-A2 positive patients with stage III or IV melanoma after receiving autologous dendritic cells pulsed with melanoma antigen peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) and treated ex vivo with CD40-ligand and interferon gamma, followed by interleukin-2 in vivo. * Determine the toxicities of this regimen in these patients. OUTLINE: This is a multicenter study. Patients undergo leukapheresis to harvest autologous dendritic cells (ADCs). Melanoma peptides (MART-1:26-35, gp100:209-217, and tyrosinase:368-376) are pulsed separately onto ADCs, which are also treated ex vivo with CD40-ligand, interferon gamma, interleukin-4, sargramostim (GM-CSF), and Candida albicans skin test reagent. Patients receive each melanoma peptide pulsed ADC vaccine separately via 3 successive 10 minute infusions on day 1. Patients then receive interleukin-2 subcutaneously every 12 hours on days 2-6. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 weeks, then every 3 months for 2 years, then every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study within 18-24 months.

Interventions

BIOLOGICALtherapeutic autologous dendritic cells

BIOLOGICALtherapeutic tumor infiltrating lymphocytes

BIOLOGICALtyrosinase peptide

BIOLOGICALsargramostim

BIOLOGICALMART-1 antigen

BIOLOGICALaldesleukin

BIOLOGICALgp100 antigen

BIOLOGICALrecombinant CD40-ligand

BIOLOGICALrecombinant interferon gamma

BIOLOGICALrecombinant interleukin-4

RADIATIONCandida albicans skin test reagent

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically confirmed metastatic melanoma * Measurable disease after attempted curative surgery * Unresectable stage III or IV uveal melanoma * Metastatic mucosal melanoma * HLA-A2.1 positive * No disease progression following high dose interleukin-2 (600,000 or 720,000 IU/kg every 8 hours) PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 75,000/mm\^3 * Hemoglobin at least 9.0 g/dL * No coagulation disorders Hepatic: * Bilirubin no greater than 2.0 mg/dL Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * Patients with documented or suspected coronary artery disease must undergo stress thallium test * No major cardiovascular illness Pulmonary: * No major pulmonary illness Immunologic: * HIV negative * Hepatitis B surface antigen negative * Hepatitis C antibody negative * No history of uveitis or autoimmune inflammatory eye disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No major systemic infection * No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior MART-1:26-35, gp100:209-217, or tyrosinase:368-376 antigens Chemotherapy: * At least 1 month since prior chemotherapy for melanoma Endocrine therapy: * No concurrent steroid therapy Radiotherapy: * At least 1 month since prior radiotherapy for melanoma Surgery: * See Disease Characteristics Other: * At least 1 month since prior adjuvant therapy for melanoma * At least 1 month since other prior therapy for melanoma

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026