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Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery

Primary Purpose

Intraocular Melanoma, Melanoma (Skin)

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MART-1 antigen
gp100 antigen
incomplete Freund's adjuvant
ipilimumab
tyrosinase peptide
adjuvant therapy
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 iris melanoma, ciliary body and choroid melanoma, small size, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed completely resected stage III or IV melanoma Mucosal or ocular subtypes allowed HLA-A2 positive Positive staining of tumor tissue with antibody HMB-45 for gp100, tyrosinase, and/or MART-1 Failed (or ineligible for or refusal of) interferon alfa PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 60-100% Life expectancy: At least 12 months Hematopoietic: WBC at least 2,500/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hematocrit at least 30% Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 1.25 times ULN Hepatitis B surface antigen negative Hepatitis C antibody nonreactive Renal: Creatinine less than 1.25 times ULN Immunologic: Antinuclear antibody (ANA) negative OR If ANA positive, must be: Antithyroglobulin antibody negative Rheumatoid factor negative Anti-LKM antibody negative Anti-phospholipid antibody negative Anti-islet cell antibody negative Anti-neutrophil cytoplasmic antibody negative HIV negative No autoimmune disease (e.g., uveitis or autoimmune inflammatory eye disease) No active infection No hypersensitivity to tyrosinase:368-376, gp100:209-217, MART-1:26-35, or Montanide ISA-51 Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix No underlying medical condition 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 anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody No prior tyrosinase, gp100, or MART-1 peptide No prior antitumor vaccination No prior interleukin-2 At least 4 weeks since prior immunotherapy for melanoma Chemotherapy: At least 4 weeks since prior chemotherapy for melanoma Endocrine therapy: At least 4 weeks since prior hormonal therapy for melanoma At least 4 weeks since prior corticosteroids No concurrent systemic or topical corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy for melanoma Surgery: See Disease Characteristics Other: No prior cytotoxic therapy At least 4 weeks since any other prior therapy for melanoma Concurrent analgesics allowed if on stable dose for at least 2 weeks before study

Sites / Locations

  • USC/Norris Comprehensive Cancer Center and Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 11, 2001
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
NCT00025181
Brief Title
Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery
Official Title
An Open-label Study Of MDX-CTLA4 In Combination With Tyrosinase/gp100/MART-1 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Resected Stage III Or Stage IV Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
January 2003 (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

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining monoclonal antibody therapy and vaccine therapy in treating patients who have stage III or stage IV melanoma that has been removed during surgery.
Detailed Description
OBJECTIVES: Determine the safety and adverse event profile of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 in patients with resected stage III or IV melanoma. Determine if this regimen causes antigen-specific T-cell activation in these patients. Determine the clearance profile of this regimen in these patients. Assess the development of host immune response in patients treated with this regimen. OUTLINE: This is a dose-escalation study of anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4). Patients receive tyrosinase:368-376, gp100:209-217, and MART-1:26-35 peptides emulsified in Montanide ISA-51 subcutaneously followed by MDX-CTLA4 IV over 90 minutes at 0, 1, 2, 3, 4, 5, 8, and 11 months in the absence of disease progression or unacceptable toxicity. Cohorts of at least 6 patients receive escalating doses of MDX-CTLA4 until the maximum tolerated dose is determined. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter until disease progression. PROJECTED ACCRUAL: A total of 18 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
iris melanoma, ciliary body and choroid melanoma, small size, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, recurrent intraocular melanoma, stage III melanoma, stage IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
MART-1 antigen
Intervention Type
Biological
Intervention Name(s)
gp100 antigen
Intervention Type
Biological
Intervention Name(s)
incomplete Freund's adjuvant
Intervention Type
Biological
Intervention Name(s)
ipilimumab
Intervention Type
Biological
Intervention Name(s)
tyrosinase peptide
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed completely resected stage III or IV melanoma Mucosal or ocular subtypes allowed HLA-A2 positive Positive staining of tumor tissue with antibody HMB-45 for gp100, tyrosinase, and/or MART-1 Failed (or ineligible for or refusal of) interferon alfa PATIENT CHARACTERISTICS: Age: Not specified Performance status: Karnofsky 60-100% Life expectancy: At least 12 months Hematopoietic: WBC at least 2,500/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hematocrit at least 30% Hepatic: Bilirubin no greater than upper limit of normal (ULN) AST no greater than 1.25 times ULN Hepatitis B surface antigen negative Hepatitis C antibody nonreactive Renal: Creatinine less than 1.25 times ULN Immunologic: Antinuclear antibody (ANA) negative OR If ANA positive, must be: Antithyroglobulin antibody negative Rheumatoid factor negative Anti-LKM antibody negative Anti-phospholipid antibody negative Anti-islet cell antibody negative Anti-neutrophil cytoplasmic antibody negative HIV negative No autoimmune disease (e.g., uveitis or autoimmune inflammatory eye disease) No active infection No hypersensitivity to tyrosinase:368-376, gp100:209-217, MART-1:26-35, or Montanide ISA-51 Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix No underlying medical condition 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 anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody No prior tyrosinase, gp100, or MART-1 peptide No prior antitumor vaccination No prior interleukin-2 At least 4 weeks since prior immunotherapy for melanoma Chemotherapy: At least 4 weeks since prior chemotherapy for melanoma Endocrine therapy: At least 4 weeks since prior hormonal therapy for melanoma At least 4 weeks since prior corticosteroids No concurrent systemic or topical corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy for melanoma Surgery: See Disease Characteristics Other: No prior cytotoxic therapy At least 4 weeks since any other prior therapy for melanoma Concurrent analgesics allowed if on stable dose for at least 2 weeks before study
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

Monoclonal Antibody and Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma That Has Been Removed During Surgery

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