Melanoma (Skin) Clinical Trial
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
Verified date | March 2003 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | August 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
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) |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
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 m — View 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. — View 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. Epub 2005 Oct 21. — View 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 cytoto — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04062032 -
Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma
|
Phase 2 | |
Completed |
NCT03620019 -
Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT03291002 -
Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC
|
Phase 1 | |
Completed |
NCT04534309 -
Behavioral Weight Loss Program for Cancer Survivors in Maryland
|
N/A | |
Completed |
NCT00962845 -
Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery
|
Early Phase 1 | |
Completed |
NCT00324623 -
Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma
|
Phase 1 | |
Completed |
NCT00104845 -
Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
|
Phase 1 | |
Completed |
NCT00096382 -
Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00089193 -
Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma
|
Phase 2 | |
Completed |
NCT00072085 -
Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00072124 -
Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma
|
Phase 3 | |
Active, not recruiting |
NCT00039234 -
Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver
|
Phase 3 | |
Completed |
NCT00042783 -
Vaccine Therapy in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
Completed |
NCT00049010 -
Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma
|
N/A | |
Completed |
NCT00020358 -
Vaccine Therapy in Treating Patients With Melanoma
|
Phase 2 | |
Completed |
NCT00006022 -
Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer
|
Phase 1 | |
Completed |
NCT00006385 -
Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00005610 -
Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung
|
Phase 2 | |
Recruiting |
NCT03767348 -
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab
|
Phase 2 | |
Withdrawn |
NCT00006126 -
Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
|
Phase 1 |