Prevention of Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Receiving a Bone Marrow Transplant
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|ClinicalTrials.gov Identifier: NCT00002790|
Recruitment Status : Withdrawn
First Posted : September 2, 2004
Last Update Posted : March 6, 2015
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RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Treatment with sirolimus, methotrexate, and cyclosporine may prevent this from happening.
PURPOSE: Phase I/II trial to study the effectiveness of sirolimus plus methotrexate and cyclosporine in preventing graft-versus-host disease in patients with hematologic malignancies who are receiving a bone marrow transplant.
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease Leukemia Myelodysplastic Syndromes||Drug: cyclosporine Drug: methotrexate Drug: sirolimus||Phase 1 Phase 2|
OBJECTIVES: I. Estimate the maximum tolerated dose of rapamycin that can be safely combined with standard methotrexate/cyclosporine prophylaxis for graft-versus-host disease (GVHD) in patients with hematologic disorders who have received a bone marrow transplant from a related donor who is mismatched for 1 HLA-A, -B, or -DR antigen in the GVHD direction.
OUTLINE: This is a dose escalation study. Groups of 6-12 patients receive escalating doses of rapamycin until the maximum tolerated dose of rapamycin given in combination with methotrexate/cyclosporine is determined. All patients receive cyclosporine from the day prior to transplant until day 50 post-transplant; the dose is then tapered over 130 days. Methotrexate is given on days 1, 3, and 6 post-transplant. Rapamycin is given every other day, days 7-59. Bone marrow transplantation occurs on day 0. Patients may not receive concurrent therapy with agents that could interfere with rapamycin metabolism, intravenous lipids, FK506 or other immunosuppressive agents (prednisone allowed), NSAIDs, or other cytotoxic agents. Patients are followed at 6 months for 2 years, then annually.
PROJECTED ACCRUAL: 12-36 patients will be accrued over 1-2.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||A PHASE I/II STUDY OF RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH METHOTREXATE (MTX) AND CYCLOSPORINE (CPS) IN PATIENTS UNDERGOING MARROW TRANSPLANTATION FROM RELATED DONORS MISMATCHED FOR ONE HLA ANTIGEN IN THE DIRECTION OF GRAFT-VERSUS-HOST DISEASE (GVHD)|
|Study Start Date :||March 1996|
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|Ages Eligible for Study:||13 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
DISEASE CHARACTERISTICS: See General Eligibility Criteria
PATIENT CHARACTERISTICS: Age: 13 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No cardiac disease No clinically significant cardiac abnormality No ischemia No recent injury on EKG Other: No intolerance or unresponsiveness to rapamycin No hypersensitivity to macrolide antibiotics, e.g., erythromycin, azithromycin, clarithromycin No requirement for medications that may significantly affect rapamycin metabolism, i.e.: Carbamazepine Ketoconazole Primidone Cimetidine Nicardipine Rifampin Diltiazem Phenobarbital Valproic acid Erythromycin Phenytoin Verapamil No uncontrolled systemic infection No pregnant or nursing women Negative pregnancy test required of fertile women Effective contraception required of fertile patients during and for 3 months after study Able to tolerate less than 400 mL of liquid oral intake
PRIOR CONCURRENT THERAPY: At least 1 week since any investigational drug
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002790
|Study Chair:||H. Joachim Deeg, MD||Fred Hutchinson Cancer Center|
|Other Study ID Numbers:||
CDR0000064855 ( Registry Identifier: PDQ )
|First Posted:||September 2, 2004 Key Record Dates|
|Last Update Posted:||March 6, 2015|
|Last Verified:||March 2015|
childhood acute lymphoblastic leukemia
chronic lymphocytic leukemia
adult acute lymphoblastic leukemia
adult acute myeloid leukemia
chronic myelogenous leukemia
childhood acute myeloid leukemia/other myeloid malignancies
graft versus host disease
childhood myelodysplastic syndromes
Graft vs Host Disease
Neoplasms by Histologic Type
Bone Marrow Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Reproductive Control Agents
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists