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

Alternate Title

Phase I/II Pilot Study of WT-1 Peptide-Loaded Allogeneic Dendritic Cell Vaccine and Donor Lymphocyte Infusion in Patients With WT1-Expressing Progressive or Relapsed Hematologic Malignancies After Prior Allogeneic Stem Cell Transplantation

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Biomarker/Laboratory analysis, Treatment	Active	1 to 75	NCI	NCI-08-C-0051 08-C-0051, NCI-P06049, NCT00608166

Special Category: NIH Clinical Center trial

Trial Description

Purpose:

Vaccines made from peptides may help the body build an effective immune response to kill cancer cells. Giving vaccine therapy together with donor lymphocytes that have been treated in the laboratory may be an effective treatment for hematologic cancer.

This phase I/II trial is studying the side effects of giving vaccine therapy together with donor lymphocyte infusion and to see how well it works in treating patients who have undergone a donor stem cell transplant for progressive or relapsed hematologic cancer.

Eligibility:

Eligibility criteria include the following:

• 1-75 years old
• No CNS cancer
• Underwent a stem cell transplant at least 6 weeks ago
• At least 2 weeks since chemotherapy or radiation therapy
• At least 4 weeks since donor lymphocyte infusion
• 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 receive injections of vaccine once in weeks 1, 3, 5, 7, 9, and 11. They will also receive an infusion of donor lymphocytes once in weeks 1, 5, and 9.

Patients will undergo blood and tissue sample collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated at 3, 4, 6, 9, and 12 months.

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

NCI - Center for Cancer Research

Alan Wayne, MD, Principal investigator		Ph: 301-496-4256

U.S.A.
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Center at John Hopkins	Ph:  410-955-8804
			Email: jhcccro@jhmi.edu
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937

Registry Information
Official Title		A Pilot Trial of WT1 Peptide-Loaded Allogeneic Dendritic Cell Vaccine and Donor Lymphocyte Infusion for WT1-Expressing Hematologic Malignancies
Trial Start Date		2007-11-01
Trial Completion Date		2009-11-02 (estimated)
Registered in ClinicalTrials.gov		NCT00608166
Date Submitted to PDQ		2008-01-18
Information Last Verified		2008-11-30