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

Alternate Title

Phase II/III Study of Disease-Specific High-Dose Conditioning Regimens Followed by Autologous Stem Cell Transplantation (Single or Tandem) in Patients With Hematologic Malignancies or Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III, Phase II	Treatment	Active	4 and over	NCI	RPCI-I-72806 I 72806, NCT00536601

Trial Description

Purpose:

Giving high-dose chemotherapy with or without total-body irradiation before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. It is also given to prepare the patient's bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood -forming cells that were destroyed by the chemotherapy and radiation therapy.

This phase II/III clinical trial is studying different high-dose chemotherapy regimens with or without total-body irradiation to compare how well they work when given before autologous stem cell transplant in treating patients with hematologic cancer or solid tumors.

Eligibility:

Eligibility criteria include the following:

• At least 4 years old
• Not planning to undergo donor stem cell transplant
• No radiation therapy within 3 weeks before stem cell collection
• 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 different high-dose chemotherapy regimens with or without total-body irradiation. They will then undergo autologous stem cell transplant. Approximately 4-8 weeks after the transplant, some patients will receive more chemotherapy followed by a second autologous stem cell transplant.

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

Roswell Park Cancer Institute

Philip McCarthy, MD, Principal investigator		Ph: 716-845-4074; 800-685-6825 Email: philip.mccarthy@roswellpark.org

U.S.A.
New York
	Buffalo
	Roswell Park Cancer Institute
		Philip McCarthy, MD	Ph:  716-845-4074
			Email: philip.mccarthy@roswellpark.org

Registry Information
Official Title		Autologous Blood and Marrow Transplantation for Hematologic Malignancies and Selected Solid Tumors
Trial Start Date		2006-06-29
Trial Completion Date		2024-04-18 (estimated)
Registered in ClinicalTrials.gov		NCT00536601
Date Submitted to PDQ		2007-08-27
Information Last Verified		2008-11-30
NCI Grant/Contract Number		CA16056