Recurrent Melanoma Clinical Trial
Official title:
A Phase III Multi-Institutional Randomized Study of Immunization With the gp100: 209-217 (210M) Peptide Followed by High Dose IL-2 vs. High Dose IL-2 Alone in Patients With Metastatic Melanoma
This randomized phase III trial studies aldesleukin with vaccine therapy to see how well it works compared to aldesleukin alone in treating patients with melanoma that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Aldesleukin may stimulate a person's white blood cells to kill melanoma cells. Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether combining aldesleukin with vaccine therapy is more effective than aldesleukin alone in treating melanoma.
PRIMARY OBJECTIVES:
I. To identify whether the addition of the peptide vaccine to high dose interleukin (IL)-2
(aldesleukin) can result in a clinical response rate which may be superior to that found in
similar patients treated with high dose IL-2 alone.
SECONDARY OBJECTIVES:
I. To evaluate the toxicity profile of patients treated on this trial, according to the
regimen received.
II. To compare the disease free/progression free survival of patients treated on both arms of
the study.
III. To determine the immunologic response experienced by patients who have received the
peptide vaccination, as measured by changes in T-cell precursors from before to after
treatment.
IV. To evaluate the quality of life of patients before and after high-dose IL-2.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive aldesleukin intravenously (IV) over 15 minutes every 8 hours for 12
doses.
ARM II: Patients receive gp100 antigen emulsified in Montanide ISA-51 subcutaneously (SC) on
day 1. Patients also receive aldesleukin as in Arm I beginning on day 2.
In both arms, treatment repeats every 3 weeks for 2 courses in the absence of disease
progression or unacceptable toxicity. Patients with stable or responding disease 3 weeks
after completing 2 courses may receive a maximum of 12 additional courses. Patients with
complete response may receive a maximum of 2 additional courses.
After completion of treatment, patients are followed up every 3 months for 1 year, every 4
months for 1 year, every 6 months for 2 years, and then annually thereafter.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT02224781 -
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
|
Phase 3 | |
Completed |
NCT02107755 -
Stereotactic Radiation Therapy and Ipilimumab in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT01886235 -
Intravital Microscopy for Identifying Tumor Vessels in Patients With Stage IA-IV Melanoma That is Being Removed by Surgery
|
N/A | |
Completed |
NCT00553306 -
Laboratory-Treated T Cells and Aldesleukin After Cyclophosphamide in Treating Patients With Stage IV Melanoma
|
Phase 1/Phase 2 | |
Completed |
NCT00121225 -
Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma
|
Phase 2 | |
Completed |
NCT00019448 -
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT01961115 -
Epacadostat and Vaccine Therapy in Treating Patients With Stage III-IV Melanoma
|
Phase 2 | |
Completed |
NCT01748747 -
Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery
|
Early Phase 1 | |
Terminated |
NCT01316692 -
Aurora A Kinase Inhibitor MLN8237 in Treating Patients With Unresectable Stage III-IV Melanoma
|
Phase 2 | |
Active, not recruiting |
NCT01120275 -
Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Stage IV Melanoma
|
Phase 2 | |
Terminated |
NCT01217411 -
RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer
|
Phase 1 | |
Terminated |
NCT01166126 -
Temsirolimus/AZD 6244 for Treatment-naive With BRAF Mutant Unresectable Stage IV
|
Phase 2 | |
Completed |
NCT01037790 -
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
|
Phase 2 | |
Completed |
NCT00288041 -
Bortezomib, Paclitaxel, and Carboplatin in Treating Patients With Metastatic Melanoma
|
Phase 2 | |
Completed |
NCT00072163 -
Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
|
Phase 2 | |
Completed |
NCT00074308 -
Imatinib Mesylate and Bevacizumab in Treating Patients With Advanced Melanoma or Other Advanced Cancers
|
Phase 1/Phase 2 | |
Completed |
NCT01989559 -
Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery
|
Phase 1 | |
Completed |
NCT00026143 -
Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Malignant Melanoma
|
Phase 2 | |
Completed |
NCT00006243 -
Vaccine Therapy and Sargramostim in Treating Patients With Stage IV Malignant Melanoma
|
N/A | |
Active, not recruiting |
NCT04284774 -
Tipifarnib for the Treatment of Advanced Solid Tumors, Lymphoma, or Histiocytic Disorders With HRAS Gene Alterations, a Pediatric MATCH Treatment Trial
|
Phase 2 |