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Vaccine Therapy in Treating Patients With Metastatic Melanoma

Primary Purpose

Intraocular Melanoma, Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MART-1 antigen
gp100:209-217(210M) peptide vaccine
therapeutic autologous dendritic cells
tyrosinase peptide
Sponsored by
University of Southern California
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intraocular Melanoma focused on measuring recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, iris melanoma, recurrent intraocular melanoma, extraocular extension melanoma

Eligibility Criteria

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

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

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital
  • University of Michigan Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Overall survival
Progression-free survival
Time to progression
Toxicity

Secondary Outcome Measures

Full Information

First Posted
June 7, 2006
Last Updated
May 19, 2014
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00334776
Brief Title
Vaccine Therapy in Treating Patients With Metastatic Melanoma
Official Title
A Phase II Trial of an Intradermally Administered MART-1gp100/Tyrosinase Peptide-Pulsed Dendritic Cell Vaccine Matured With a Cytokine Cocktail for Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (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

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intraocular Melanoma, Melanoma (Skin)
Keywords
recurrent melanoma, stage IV melanoma, ciliary body and choroid melanoma, medium/large size, iris melanoma, recurrent intraocular melanoma, extraocular extension melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
MART-1 antigen
Intervention Type
Biological
Intervention Name(s)
gp100:209-217(210M) peptide vaccine
Intervention Type
Biological
Intervention Name(s)
therapeutic autologous dendritic cells
Intervention Type
Biological
Intervention Name(s)
tyrosinase peptide
Primary Outcome Measure Information:
Title
Overall survival
Title
Progression-free survival
Title
Time to progression
Title
Toxicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
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
90089-9181
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0942
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy in Treating Patients With Metastatic Melanoma

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