Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I Pilot Randomized Study of Melanoma Peptide Vaccine With or Without Sargramostim (GM-CSF) in Patients With High-Risk or Metastatic Melanoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	CPMC-IRB-13824 LUDWIG-LUD00-025, NCI-G02-2068, NCT00037037

Trial Description

Purpose:

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.

Randomized phase I trial to study the effectiveness of vaccine therapy with or without sargramostim in treating patients who have metastatic melanoma.

Eligibility:

• At least 18 years old
• No previous bone marrow or stem cell transplantation
• At least 4 weeks since biological therapy, chemotherapy, radiation therapy, or surgery
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned to one of two groups. Patients in group one will receive five injections of vaccine each week for 6 weeks. Patients in group two will receive injections of vaccine as in group one. They will also receive an injection of sargramostim 7 days a week. Patients will be evaluated at 2 weeks.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

Kyriakos Papadopoulos, MD, Protocol chair(Contact information may not be current)		Ph: 212-305-9327

Registry Information
Official Title		A Phase I Study of Peptide Based Vaccine Therapy in Patients with High-Risk or Metastatic Melanoma
Trial Start Date		2001-10-10
Registered in ClinicalTrials.gov		NCT00037037
Date Submitted to PDQ		2002-04-02
Information Last Verified		2004-05-07
NCI Grant/Contract Number		P30-CA13696

Back to Top