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

Primary Purpose

Melanoma (Skin)

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MART-1 antigen
aldesleukin
gp100 antigen
recombinant CD40-ligand
recombinant interferon gamma
recombinant interleukin-4
sargramostim
therapeutic autologous dendritic cells
therapeutic tumor infiltrating lymphocytes
tyrosinase peptide
Candida albicans skin test reagent
Sponsored by
University of Southern California
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma (Skin) focused on measuring stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2000
Last Updated
May 20, 2014
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00006113
Brief Title
Vaccine Therapy Followed by Biological Therapy in Treating Patients With Stage III or Stage IV Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
June 1999 (undefined)
Primary Completion Date
May 2003 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma (Skin)
Keywords
stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
MART-1 antigen
Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
gp100 antigen
Intervention Type
Biological
Intervention Name(s)
recombinant CD40-ligand
Intervention Type
Biological
Intervention Name(s)
recombinant interferon gamma
Intervention Type
Biological
Intervention Name(s)
recombinant interleukin-4
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous dendritic cells
Intervention Type
Biological
Intervention Name(s)
therapeutic tumor infiltrating lymphocytes
Intervention Type
Biological
Intervention Name(s)
tyrosinase peptide
Intervention Type
Radiation
Intervention Name(s)
Candida albicans skin test reagent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S. Weber, MD, PhD
Organizational Affiliation
University of Southern California
Official's Role
Study Chair
Facility Information:
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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