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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jeffrey S. Weber, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

USC/Norris Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068125 (10M-99-1)

NCT ID:

NCT00006113

Start Date:

June 1999

Completion Date:

April 2006

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location

USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804