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 II Study of HLA-Matched Nonmyeloablative Peripheral Blood Stem Cell Transplantation Followed By Allogeneic T-Cell Infusion as Adoptive Immunotherapy in Patients With Metastatic Renal Cell Carcinoma

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active 18 to 80 NHLBI NHLBI-97-H-0196 NCT00003553

Special Category: NIH Clinical Center trial

Trial Description

Purpose:

Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before a donor peripheral blood stem cell transplant helps stop the growth of tumor cells. It may also stop the patient’s immune system from rejecting the donor’s stem cells. The donated stem cells may replace the patient’s immune cells and help destroy any remaining tumor cells (graft-versus-tumor effect). Giving an infusion of the donor’s T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine with or without mycophenolate mofetil or methotrexate after the transplant may stop this from happening.

This phase II trial is studying how well peripheral stem cell transplant works in treating patients with metastatic kidney cancer.

Eligibility:

Eligibility criteria include the following:

• 18-80 years old
• Evaluable disease
• Family donor available
• No CNS metastases
• At least 1 month since treatment for kidney cancer
• 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 chemotherapy during a 7-day period. On day 8, they will undergo peripheral stem cell transplant. Treatment with stem cells may be repeated on days 9 and 10. Patients will also receive cyclosporine beginning 4 days before the transplant and continuing for up to approximately 3 months. Some patients may also receive mycophenolate mofetil or methotrexate. Some patients may receive infusions of donated T cells.

Patients will be evaluated every 2 months for 6 months, every 3 months for 2 years, and every 6 months until year 5.

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

National Heart, Lung, and Blood Institute

Richard Childs, MD, Protocol chair		Ph: 301-594-8008 Email: childsr@nih.gov

U.S.A.
Maryland
	Bethesda
	NIH - Warren Grant Magnuson Clinical Center
		Patient Recruitment	Ph:  800-411-1222

Registry Information
Official Title		A Phase II Study of HLA-Matched Peripheral Blood Mobilized Hematopoietic Progenitor Cell Transplantation for Metastatic Renal Cell Carcinoma Followed by Allogeneic T-Cell Infusion as Adoptive Immunotherapy
Trial Start Date		1999-01-05
Trial Completion Date		2009-12-30 (estimated)
Registered in ClinicalTrials.gov		NCT00003553
Date Submitted to PDQ		1998-08-12
Information Last Verified		2008-11-30