Melanoma (Skin) Clinical Trial
Official title:
A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill
tumor cells. Colony-stimulating factors such as sargramostim may increase the number of
immune cells found in bone marrow or peripheral blood. Combining vaccine therapy with
sargramostim may kill more tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy with or
without sargramostim in treating patients who have metastatic melanoma.
OBJECTIVES:
- Compare the safety of melanoma peptide vaccine with or without sargramostim (GM-CSF) in
patients with high-risk or metastatic melanoma.
- Compare changes in peptide-specific cellular and humoral immunologic profiles in
patients treated with these regimens.
- Compare tumor response in patients treated with these regimens.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment
arms.
- Arm I: Patients receive melanoma peptide vaccine comprising tyrosinase leader injected
at 2 separate sites, Melan-A ELA injected at another site, NY-ESO-1a and NY-ESO-1b
combined and injected at one site, and MAGE-10.A2 injected at another site,
intradermally once weekly on weeks 1-6.
- Arm II: Patients receive vaccine as in arm I. Patients also receive sargramostim
(GM-CSF) subcutaneously daily beginning 2 days before each vaccination and continuing
for 5 days.
Treatment in both arms continues through week 6 in the absence of disease progression or
unacceptable toxicity.
Patients are followed at 2 weeks.
PROJECTED ACCRUAL: A total of 20 patients (10 per treatment arm) will be accrued for this
study within 18 months.
;
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
| 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 |
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 |
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 | |
| 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 | |
| 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 |