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Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

Primary Purpose

Melanoma (Skin)

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MAGE-10.A2
MART-1 antigen
NY-ESO-1 peptide vaccine
sargramostim
tyrosinase peptide
Sponsored by
Herbert Irving Comprehensive Cancer Center
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 high-risk stage III or IV melanoma Stage III disease less than 6 months after surgical resection Completed prior interferon alfa therapy OR Progressive disease or major adverse events during prior interferon alfa therapy Stage III disease at least 6 months after surgical resection Declined, failed, or completed prior standard therapy Stage IV disease Declined, failed, or completed prior standard therapy HLA-A2 positive No CNS metastases unless treated and stable PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: At least 4 months Hematopoietic: Neutrophil count at least 1,500/mm3 Lymphocyte count at least 500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg) No bleeding disorder Hepatic: Bilirubin no greater than 2.0 mg/dL No hepatitis B or C positivity Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: HIV negative No other serious illness No serious infection requiring antibiotics No history of immunodeficiency disease or autoimmune disease No psychiatric or addictive disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior bone marrow or stem cell transplantation At least 4 weeks since prior immunotherapy or biologic therapy No other concurrent immunotherapy or biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No concurrent chemotherapy Endocrine therapy: No concurrent systemic corticosteroids No concurrent steroids except topical or inhalational steroids Concurrent hormonal therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery Other: At least 4 weeks since prior investigational agents Concurrent noncytotoxic anticancer therapy allowed No concurrent immunosuppressive therapy No concurrent antihistamines No concurrent non-steroidal anti-inflammatory drugs except in low doses for prevention of an acute cardiovascular event or pain control

Sites / Locations

  • Herbert Irving Comprehensive Cancer Center at Columbia University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 13, 2002
Last Updated
December 17, 2013
Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00037037
Brief Title
Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
Official Title
A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2004
Overall Recruitment Status
Unknown status
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Herbert Irving Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with sargramostim may kill more tumor cells. PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.
Detailed Description
OBJECTIVES: Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in patients with high-risk or metastatic melanoma. Compare changes in peptide-specific cellular and humoral immunologic profiles in patients treated with these regimens. Compare tumor response in patients treated with these regimens. OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b combined and injected at one site, and MAGE-10.A2 injected at another site, intradermally once weekly on weeks 1-6. Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim (GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing for 5 days. Treatment in both arms continues through week 6 in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this study within 18 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 1
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
MAGE-10.A2
Intervention Type
Biological
Intervention Name(s)
MART-1 antigen
Intervention Type
Biological
Intervention Name(s)
NY-ESO-1 peptide vaccine
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Biological
Intervention Name(s)
tyrosinase peptide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed high-risk stage III or IV melanoma Stage III disease less than 6 months after surgical resection Completed prior interferon alfa therapy OR Progressive disease or major adverse events during prior interferon alfa therapy Stage III disease at least 6 months after surgical resection Declined, failed, or completed prior standard therapy Stage IV disease Declined, failed, or completed prior standard therapy HLA-A2 positive No CNS metastases unless treated and stable PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: At least 4 months Hematopoietic: Neutrophil count at least 1,500/mm3 Lymphocyte count at least 500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL (10.0 g/dL if less than 50 kg) No bleeding disorder Hepatic: Bilirubin no greater than 2.0 mg/dL No hepatitis B or C positivity Renal: Creatinine no greater than 1.8 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: HIV negative No other serious illness No serious infection requiring antibiotics No history of immunodeficiency disease or autoimmune disease No psychiatric or addictive disorder that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior bone marrow or stem cell transplantation At least 4 weeks since prior immunotherapy or biologic therapy No other concurrent immunotherapy or biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) No concurrent chemotherapy Endocrine therapy: No concurrent systemic corticosteroids No concurrent steroids except topical or inhalational steroids Concurrent hormonal therapy allowed Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics At least 4 weeks since prior surgery Other: At least 4 weeks since prior investigational agents Concurrent noncytotoxic anticancer therapy allowed No concurrent immunosuppressive therapy No concurrent antihistamines No concurrent non-steroidal anti-inflammatory drugs except in low doses for prevention of an acute cardiovascular event or pain control
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyriakos P. Papadopoulos, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

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Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma

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