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

Alternate Title

Pilot Study of Busulfan, Cyclophosphamide, and Fludarabine Phosphate Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Younger Patients With Epidermolysis Bullosa at High Risk of Developing Squamous Cell Carcinoma of the Skin

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Prevention, Treatment Active 25 and under Other UMN-MT2006-15 MT2006-15, UMN-0702M01504, NCT00478244

Trial Description

Purpose:

Giving chemotherapy before a donor stem cell transplant helps stop the growth of abnormal cells. It also helps stop the patient’s immune system from rejecting the donor’s stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient’s bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body’s normal cells. Giving cyclosporine together with mycophenolate mofetil before, during, and after transplant may stop this from happening.

This clinical trial is studying how well combination chemotherapy followed by donor stem cell transplant works in treating young patients with epidermolysis bullosa at high risk of developing squamous cell skin cancer.

Eligibility:

Eligibility criteria include the following:

• 25 years old and younger
• No squamous cell skin cancer
• No previous donor skin transplant
• 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 a 2-hour infusion of busulfan every 6 hours on days 1-6, a 1-hour infusion of fludarabine on days 5-7, and a 1-hour infusion of cyclophosphamide on days 5-8. They will undergo donor stem cell transplant on day 10. Patients will receive cyclosporine as a 2-hour infusion or by mouth every 8 hours beginning on day 7 and continuing for 6 months and mycophenolate mofetil by infusion or by mouth beginning on day 7 and continuing for 1 month. Some patients will also undergo donor skin cell transplant at approximately 3½ months.

After finishing treatment, patients will be evaluated periodically for at least 5 years.

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

Masonic Cancer Center at University of Minnesota

John Wagner, MD, Protocol chair		Ph: 612-626-2961; 888-226-2376

U.S.A.
Minnesota
	Minneapolis
	Masonic Cancer Center at University of Minnesota
		Clinical Trials Office - Masonic Cancer Center at University of Minnesota	Ph:  612-624-2620

Registry Information
Official Title		Allogeneic Hematopoietic Cell Transplantation to Correct the Biochemical Defect and Create Tolerance to Donor Tissue in Subjects with Epidermolysis Bullosa
Trial Start Date		2007-04-25
Registered in ClinicalTrials.gov		NCT00478244
Date Submitted to PDQ		2007-04-30
Information Last Verified		2008-03-30
NCI Grant/Contract Number		CA77598