Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Melanoma (Skin) |
Biological: MART-1 antigen Biological: aldesleukin Biological: gp100 antigen Biological: recombinant CD40-ligand Biological: recombinant interferon gamma Biological: recombinant interleukin-4 Biological: sargramostim Biological: therapeutic autologous dendritic cells Biological: therapeutic tumor infiltrating lymphocytes Biological: tyrosinase peptide Radiation: Candida albicans skin test reagent |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
| Enrollment: | 25 |
| Study Start Date: | June 1999 |
| Study Completion Date: | April 2006 |
| Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, California | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90089 | |
| Study Chair: | Jeffrey S. Weber, MD, PhD | USC/Norris Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | USC/Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00006113 History of Changes |
| Other Study ID Numbers: | CDR0000068125 (10M-99-1), LAC-USC-10M991, NCI-G00-1837, NCI-T99-0102 |
| Study First Received: | August 3, 2000 |
| Last Updated: | October 20, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by USC/Norris Comprehensive Cancer Center:
|
stage III melanoma stage IV melanoma recurrent melanoma |
Additional relevant MeSH terms:
|
Melanoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Interferon-gamma Interferons Aldesleukin Interleukin-4 |
Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antineoplastic Agents Antirheumatic Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Anti-HIV Agents Anti-Retroviral Agents |
ClinicalTrials.gov processed this record on June 18, 2013