Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy together with GM-CSF, CpG 7909, and incomplete Freund's adjuvant may make a stronger immune response and kill more tumor cells.

PURPOSE: This clinical trial is studying the side effects and how well vaccine therapy works in treating patients with recurrent stage III or stage IV melanoma that cannot be removed by surgery.


Clinical Trial Description

OBJECTIVES:

- Determine the safety of a peptide vaccine comprising MART-1:27-35 peptide, gp100:209-217 (210M) peptide, and tyrosinase peptide with sargramostim (GM-CSF) and CpG 7909 emulsified in incomplete Freund's adjuvant in patients with unresectable recurrent stage III or IV melanoma.

- Determine the efficacy of immunoadjuvants CpG 7909 and GM-CSF, in terms of a strong antigen-specific CD8+ T-cell response, in these patients.

- Determine the anti-pigmentary response to this regimen in these patients.

- Determine the anti-tumor response, in terms of objective tumor regression, progression-free survival, and overall survival, in patients treated with this regimen.

OUTLINE: This is a pilot study.

Patients receive peptide vaccine comprising MART-1:27-35 peptide, gp100:209-217 (210M) peptide, and tyrosinase peptide with sargramostim (GM-CSF) and CpG 7909 emulsified in incomplete Freund's adjuvant subcutaneously on days 1 and 15. Treatment repeats every 28 days for up to 13 courses in the absence of disease progression or unacceptable toxicity.

Blood samples are collected at baseline, day 50-53, and day 91-94. Samples are examined by ELISPOT assay to measure lymphocyte immune response and by flow cytometry for biomarker quantification and T-cell response.

After completion of study treatment, patients are followed up periodically for at least 2 years. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00471471
Study type Interventional
Source University of Pittsburgh
Contact
Status Completed
Phase Phase 1
Start date October 2008
Completion date December 2011

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 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 NCT00072124 - Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma Phase 3
Completed NCT00072085 - Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic 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 NCT00006385 - Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma Phase 2
Completed NCT00020358 - Vaccine Therapy in Treating Patients With Melanoma Phase 2
Completed NCT00005610 - Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung Phase 2
Completed NCT00006022 - Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer Phase 1
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