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Sponsored by: |
Masonic Cancer Center, University of Minnesota |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00478244 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention |
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Non-Melanomatous Skin Cancer Precancerous/Nonmalignant Condition |
Drug: busulfan Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Procedure: umbilical cord blood transplantation |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Allogeneic Hematopoietic Cell Transplantation to Correct the Biochemical Defect and Create Tolerance to Donor Tissue in Subjects With Epidermolysis Bullosa |
Estimated Enrollment: | 30 |
Study Start Date: | April 2007 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, pilot study.
Conditioning regimen: Patients receive busulfan IV over 2 hours every 6 hours on days -9 to -4, fludarabine phosphate IV over 1 hour on days -5 to
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Ages Eligible for Study: | up to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of epidermolysis bullosa (EB)
Documented collagen type VII deficiency by the following methods:
Healthy related hematopoietic stem cell donor available and meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Minnesota | |
Masonic Cancer Center at University of Minnesota | Recruiting |
Minneapolis, Minnesota, United States, 55455 | |
Contact: Clinical Trials Office - Masonic Cancer Center at University o 612-624-2620 |
Study Chair: | John E. Wagner, MD | Masonic Cancer Center, University of Minnesota |
Study ID Numbers: | CDR0000546620, UMN-MT2006-15, UMN-0702M01504 |
Study First Received: | May 23, 2007 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00478244 History of Changes |
Health Authority: | Unspecified |
squamous cell carcinoma of the skin epidermolysis bullosa |
Antimetabolites Cyclosporine Precancerous Conditions Immunologic Factors Clotrimazole Miconazole Epidermolysis Bullosa Cyclophosphamide Squamous Cell Carcinoma Cyclosporins Antifungal Agents Mycophenolate mofetil Congenital Abnormalities Skin Diseases, Genetic Alkylating Agents |
Skin Diseases, Vesiculobullous Skin Diseases Tioconazole Skin Abnormalities Fludarabine monophosphate Skin Neoplasms Immunosuppressive Agents Carcinoma Genetic Diseases, Inborn Busulfan Epidermoid Carcinoma Fludarabine Antineoplastic Agents, Alkylating Carcinoma, Squamous Cell Antirheumatic Agents |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Precancerous Conditions Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Epidermolysis Bullosa Cyclosporins Neoplasms by Site Antifungal Agents Therapeutic Uses |
Mycophenolate mofetil Congenital Abnormalities Dermatologic Agents Skin Diseases, Genetic Alkylating Agents Skin Diseases, Vesiculobullous Skin Diseases Skin Abnormalities Enzyme Inhibitors Fludarabine monophosphate Skin Neoplasms Immunosuppressive Agents Pharmacologic Actions Neoplasms Genetic Diseases, Inborn |