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Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

Primary Purpose

Intraocular Melanoma, Melanoma (Skin)

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gp100 antigen
incomplete Freund's adjuvant
ipilimumab
Sponsored by
National Cancer Institute (NCI)
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 IV melanoma, recurrent melanoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically confirmed stage IV melanoma Mucosal or ocular melanoma allowed Clinically evaluable disease HLA-A*0201 positive PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: At least 6 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: AST no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than ULN (less than 3.0 mg/dL in patients with Gilbert's syndrome) Hepatitis B surface antigen negative Hepatitis C antibody nonreactive Renal: Creatinine less than 2.0 mg/dL Immunologic: Antinuclear antibody negative Thyroglobulin antibody normal Rheumatoid factor normal HIV negative No prior autoimmune disease (including uveitis and autoimmune inflammatory eye disease) No active infection No hypersensitivity to Montanide ISA-51 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 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 other underlying medical condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy for melanoma and recovered No prior gp100 peptides No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody Chemotherapy: At least 3 weeks since prior chemotherapy for melanoma and recovered No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy for melanoma and recovered At least 4 weeks since prior systemic or topical corticosteroids No concurrent topical or systemic corticosteroids Radiotherapy: At least 3 weeks since prior radiotherapy for melanoma and recovered Surgery: Not specified Other: No other concurrent immunosuppressive agents (e.g., cyclosporine and its analog)

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 8, 2002
Last Updated
June 18, 2013
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00032045
Brief Title
Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma
Official Title
An Open-label Study Of MDX-010 In Combination With gp100 Peptides Emulsified With Montanide ISA 51 In The Treatment Of Patients With Stage IV Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2003
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
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. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining vaccine therapy with a monoclonal antibody may cause a stronger immune response and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy with monoclonal antibody therapy in treating patients who have stage IV melanoma.
Detailed Description
OBJECTIVES: Determine the clinical response in patients with stage IV melanoma when treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody combined with gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51. Determine a safety and adverse event profile of this regimen in these patients. Determine improved immunologic response in patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV over 90 minutes immediately followed by gp100:209-217 and gp100:280-288 peptides emulsified in Montanide ISA-51 subcutaneously on days 1, 22, 43, and 64. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 68 patients will be accrued for this study within 2 years.

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 IV melanoma, recurrent melanoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed stage IV melanoma Mucosal or ocular melanoma allowed Clinically evaluable disease HLA-A*0201 positive PATIENT CHARACTERISTICS: Age: 16 and over Performance status: Karnofsky 60-100% Life expectancy: At least 6 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: AST no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than ULN (less than 3.0 mg/dL in patients with Gilbert's syndrome) Hepatitis B surface antigen negative Hepatitis C antibody nonreactive Renal: Creatinine less than 2.0 mg/dL Immunologic: Antinuclear antibody negative Thyroglobulin antibody normal Rheumatoid factor normal HIV negative No prior autoimmune disease (including uveitis and autoimmune inflammatory eye disease) No active infection No hypersensitivity to Montanide ISA-51 Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception 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 other underlying medical condition that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy for melanoma and recovered No prior gp100 peptides No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody Chemotherapy: At least 3 weeks since prior chemotherapy for melanoma and recovered No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy for melanoma and recovered At least 4 weeks since prior systemic or topical corticosteroids No concurrent topical or systemic corticosteroids Radiotherapy: At least 3 weeks since prior radiotherapy for melanoma and recovered Surgery: Not specified Other: No other concurrent immunosuppressive agents (e.g., cyclosporine and its analog)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven A. Rosenberg, MD, PhD
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16301685
Citation
Maker AV, Attia P, Rosenberg SA. Analysis of the cellular mechanism of antitumor responses and autoimmunity in patients treated with CTLA-4 blockade. J Immunol. 2005 Dec 1;175(11):7746-54. doi: 10.4049/jimmunol.175.11.7746.
Results Reference
background
PubMed Identifier
16283570
Citation
Maker AV, Phan GQ, Attia P, Yang JC, Sherry RM, Topalian SL, Kammula US, Royal RE, Haworth LR, Levy C, Kleiner D, Mavroukakis SA, Yellin M, Rosenberg SA. Tumor regression and autoimmunity in patients treated with cytotoxic T lymphocyte-associated antigen 4 blockade and interleukin 2: a phase I/II study. Ann Surg Oncol. 2005 Dec;12(12):1005-16. doi: 10.1245/ASO.2005.03.536. Epub 2005 Oct 21.
Results Reference
background
PubMed Identifier
16087944
Citation
Attia P, Phan GQ, Maker AV, Robinson MR, Quezado MM, Yang JC, Sherry RM, Topalian SL, Kammula US, Royal RE, Restifo NP, Haworth LR, Levy C, Mavroukakis SA, Nichol G, Yellin MJ, Rosenberg SA. Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anti-cytotoxic T-lymphocyte antigen-4. J Clin Oncol. 2005 Sep 1;23(25):6043-53. doi: 10.1200/JCO.2005.06.205. Epub 2005 Aug 8.
Results Reference
result
PubMed Identifier
12826605
Citation
Phan GQ, Yang JC, Sherry RM, Hwu P, Topalian SL, Schwartzentruber DJ, Restifo NP, Haworth LR, Seipp CA, Freezer LJ, Morton KE, Mavroukakis SA, Duray PH, Steinberg SM, Allison JP, Davis TA, Rosenberg SA. Cancer regression and autoimmunity induced by cytotoxic T lymphocyte-associated antigen 4 blockade in patients with metastatic melanoma. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8372-7. doi: 10.1073/pnas.1533209100. Epub 2003 Jun 25.
Results Reference
result
PubMed Identifier
25667295
Citation
Schadendorf D, Hodi FS, Robert C, Weber JS, Margolin K, Hamid O, Patt D, Chen TT, Berman DM, Wolchok JD. Pooled Analysis of Long-Term Survival Data From Phase II and Phase III Trials of Ipilimumab in Unresectable or Metastatic Melanoma. J Clin Oncol. 2015 Jun 10;33(17):1889-94. doi: 10.1200/JCO.2014.56.2736. Epub 2015 Feb 9.
Results Reference
derived

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Vaccine Therapy and Monoclonal Antibody Therapy in Treating Patients With Stage IV Melanoma

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