Related Links Educational Materials About Clinical Trials Clinical Trials: Questions and Answers 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/II Randomized Study of Vaccination Comprising MART-1/gp100/Tyrosinase/NY-ESO-1/MAGE-3 Peptide-Pulsed Dendritic Cells Matured Using Cytokines in Combination With Autologous Lymphocyte Infusion With or Without Fludarabine in Patients With Chemotherapy-Naïve Metastatic Melanoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Active 16 and over NCI MCC-13649 LAC-USC-10M-05-2, 6241, NCI-6241, LAC-USC-HS-05-00068, NCT00313508

Trial Description

Purpose:

Vaccines made from a person’s dendritic cells that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving an infusion of autologous lymphocytes and then infusing the vaccine directly into a lymph node may cause a stronger immune response and kill more tumor cells. Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vaccine therapy and autologous lymphocyte infusion together with fludarabine may kill more tumor cells.

This randomized phase I/II trial is studying the side effects and best dose of fludarabine followed by autologous lymphocyte infusion and vaccine therapy and to see how well it works in treating patients with metastatic melanoma.

Eligibility:

Eligibility criteria include the following:

• At least 16 years old
• Measurable disease
• No previous chemotherapy
• More than 1 month since treatment for melanoma
• At least 1 month since 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 (have an equal chance of being placed) to one of two treatment groups. All patients will undergo two apheresis procedures to collect lymphocytes and dendritic cells.

Beginning 3 days after the second apheresis procedure, patients in group one will receive an infusion of fludarabine on days 1-5. They will also receive a 1-hour infusion of autologous lymphocytes on day 8. Patients will receive a 24-hour continuous infusion of the vaccine into a lymph node in weeks 2, 3, 5, and 7. Treatment may repeat approximately 4 weeks to 6 months later.

Patients in group two will receive a 1-hour infusion of autologous lymphocytes on day 8. They will also receive a 24-hour continuous infusion of the vaccine into a lymph node in weeks 2, 3, 5, and 7. Treatment may repeat approximately 4 weeks to 6 months later.

After finishing treatment, patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and once a year thereafter.

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

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Jeffrey Weber, MD, PhD, Protocol chair		Ph: 813-745-4261; 888-663-3488

U.S.A.
Florida
	Tampa
	H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
		Clinical Trials Office - H. Lee Moffitt Cancer Center and Reseach Institute	Ph:  800-456-7121
			Email: canceranswers@moffitt.org

Registry Information
Official Title		A Dose Ranging Trial of MART-1/gp100/Tyrosinase/NY-ESO-1 Peptide-Pulsed Dendritic Cells Matured Using Cytokines with Autologous Lymphocyte Infusion With or Without Escalating Doses of Fludarabine for Patients With Chemotherapy-naive Metastatic Melanoma
Trial Start Date		2006-02-01
Trial Completion Date		2009-03-02 (estimated)
Registered in ClinicalTrials.gov		NCT00313508
Date Submitted to PDQ		2005-12-22
Information Last Verified		2008-04-10
NCI Grant/Contract Number		CA14089, CA105139, CA76292