Vaccine Therapy With or Without Sargramostim in Treating Patients With High-Risk or Metastatic Melanoma
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|ClinicalTrials.gov Identifier: NCT00037037|
Recruitment Status : Unknown
Verified May 2004 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : December 18, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: MAGE-10.A2 Biological: MART-1 antigen Biological: NY-ESO-1 peptide vaccine Biological: sargramostim Biological: tyrosinase peptide||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Peptide Based Vaccine Therapy in Patients With High-Risk or Metastatic Melanoma|
|Study Start Date :||October 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037037
|United States, New York|
|Herbert Irving Comprehensive Cancer Center at Columbia University|
|New York, New York, United States, 10032|
|Study Chair:||Kyriakos P. Papadopoulos, MD||Herbert Irving Comprehensive Cancer Center|