Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Vaccines may make the body build an immune response to kill tumor cells. Combining the vaccines with Montanide ISA-51 may cause a stronger immune response and kill more tumor cells. Giving monoclonal antibody therapy together with vaccine therapy may be an effective treatment for stage III or stage IV melanoma. PURPOSE: This phase II trial is studying how well giving monoclonal antibody therapy together with vaccine therapy works in treating patients with resected stage III or stage IV melanoma.


Clinical Trial Description

OBJECTIVES: Primary - Achieve at least a 40% autoimmune breakthrough event rate, as defined by the induction of grade 1, grade 2, or acceptable grade 3 drug-related autoimmune adverse events, in patients with resected stage III or IV melanoma treated with anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51. Secondary - Determine the incidence of drug-related autoimmune adverse events of any grade in patients treated with this regimen. - Determine the time to disease relapse in patients treated with this regimen. - Determine the 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 (MDX-010) IV over 90 minutes on day 1 of weeks 1, 9, 17, 25, 33, 41, and 53 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen emulsified in Montanide ISA-51 subcutaneously on day 1 of weeks 1, 3, 5, 7, 9, 11, 17, 21, 25, 33, 41, and 53. Patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00084656
Study type Interventional
Source Bristol-Myers Squibb
Contact
Status Completed
Phase Phase 2
Start date May 31, 2004
Completion date October 31, 2009

See also
  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 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 NCT00104845 - Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma Phase 1
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
Completed NCT00089193 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma Phase 2
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 NCT00006385 - Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma Phase 2
Completed NCT00006022 - Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer Phase 1
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