Total-Body Irradiation and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer and Other Diseases
This study has been completed.
Sponsor:
Fred Hutchinson Cancer Research Center
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00317785
First received: April 24, 2006
Last updated: May 5, 2010
Last verified: May 2010
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Purpose
RATIONALE: Giving total-body irradiation and chemotherapy, such as cyclophosphamide, before a donor stem cell transplant helps stop the patient's immune system from rejecting the donor's stem cells and helps stop the growth of cancer or abnormal 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 immunosuppressive therapy before or after transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving total-body irradiation together with cyclophosphamide works in treating patients who are undergoing donor stem cell transplant for hematologic cancer and other diseases.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma Myelodysplastic Syndromes |
Drug: cyclophosphamide Drug: cyclosporine Drug: methotrexate Drug: mycophenolate mofetil Drug: sirolimus Drug: tacrolimus Other: pharmacological study Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation Radiation: total-body irradiation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial of Total Body Irradiation Plus Metabolism-Based Cyclophosphamide Dosing as Preparative Therapy for Allogeneic Hematopoietic Cell Transplant for Patients With Hematological Malignancy |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Bone Marrow Transplantation
Cancer
Chronic Myeloid Leukemia
Hodgkin Disease
Leukemia
Lymphoma
Myelodysplastic Syndromes
Drug Information available for:
Cyclophosphamide
Methotrexate
Methotrexate sodium
Mycophenolic acid
Mycophenolate sodium
Sirolimus
Cyclosporine
Tacrolimus
Mycophenolate mofetil hydrochloride
Mycophenolate mofetil
Everolimus
Temsirolimus
U.S. FDA Resources
Further study details as provided by Fred Hutchinson Cancer Research Center:
Primary Outcome Measures:
- Non-relapse mortality (NRM) at 200 days [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Designated as safety issue: No ]
- Relapse rate [ Designated as safety issue: No ]
- Sinusoidal obstruction syndrome (SOS) [ Designated as safety issue: No ]
- Acute renal failure [ Designated as safety issue: No ]
- Respiratory failure [ Designated as safety issue: No ]
- Cause of death [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2005 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Evaluate the potential efficacy of targeting cyclophosphamide to a metabolic endpoint when given together with total-body irradiation, in terms of day 200 nonrelapse mortality, in patients with hematologic cancer and other diseases who are undergoing allogeneic hematopoietic stem cell transplantation.
Secondary
- Determine the overall survival of patients treated with this regimen.
- Determine the rate of relapse in patients treated with this regimen.
- Determine the occurrence of sinusoidal obstruction syndrome in patients treated with this regimen.
- Determine the occurrence of acute renal failure in these patients.
- Determine the occurrence of respiratory failure in these patients.
OUTLINE:
- Conditioning regimen: Patients undergo total-body irradiation twice daily on days -6 to -4. Patients also receive cyclophosphamide IV over 1 hour on day -3 and then IV at a metabolism-based dose* on day -2.
NOTE: *Patients undergo frequent blood sampling after completion of the first cyclophosphamide infusion for pharmacokinetic studies in order to determine the dose for the second cyclophosphamide infusion.
- Allogeneic stem cell transplantation: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0.
- Graft-versus-host disease (GVHD) prophylaxis: Patients receive GVHD prophylaxis as per the attending physician, including one of the following regimens: cyclosporine and methotrexate; tacrolimus and methotrexate; tacrolimus and mycophenolate mofetil; or sirolimus, tacrolimus, and methotrexate (as per the GVHD prophylaxis regimen chosen for each patient).
After completion of study treatment, patients are followed periodically for at least 200 days.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Diagnosis of a hematologic cancer or other disease that is unlikely to respond to conventional treatment, including any of the following:
- Chronic myelogenous leukemia
- Acute myeloid leukemia
- Acute lymphocytic leukemia
- Myelodysplastic syndromes
- Lymphoma
- Patients who have bulky tumor mass must not require additional involved-field irradiation
- Planning to undergo conditioning for transplantation at the Seattle Cancer Care Alliance and University of Washington Medical Center
Must have an HLA-matched donor available
- No donors who are mismatched for > 1 HLA class I antigen or allele
- Negative anti-donor lymphocytotoxic crossmatch
PATIENT CHARACTERISTICS:
- Life expectancy must not be severely limited by diseases other than malignancy
- No moribund patients
- Creatinine ≤ 1.2 mg/dL
- Oxygen saturation on room air ≥ 93%
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No HIV positivity
- No cirrhosis
- No hepatic fibrosis with bridging
- No fulminant hepatic failure
- No acute liver injury
- No persistent cholestasis
- No infection requiring systemic antibiotic or antifungal therapy
- No coronary artery disease
- No congestive heart failure requiring therapy
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior hematopoietic stem cell transplantation
- No prior radiation therapy to the liver or adjacent organs
- More than 30 days since prior cytoreductive chemotherapy for patients with a large body burden of tumor cells
- No concurrent enrollment in a phase I study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317785
Locations
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| Seattle Cancer Care Alliance | |
| Seattle, Washington, United States, 98109-1023 | |
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
| Principal Investigator: | George B. McDonald, MD | Fred Hutchinson Cancer Research Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00317785 History of Changes |
| Other Study ID Numbers: | 1998.00, FHCRC-1998.00, CDR0000471840 |
| Study First Received: | April 24, 2006 |
| Last Updated: | May 5, 2010 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Fred Hutchinson Cancer Research Center:
|
adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) accelerated phase chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission blastic phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma noncontiguous stage II adult Burkitt lymphoma noncontiguous stage II adult diffuse large cell lymphoma |
noncontiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse small cleaved cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult lymphoblastic lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma noncontiguous stage II mantle cell lymphoma noncontiguous stage II marginal zone lymphoma noncontiguous stage II small lymphocytic lymphoma previously treated myelodysplastic syndromes recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia recurrent adult Burkitt lymphoma recurrent adult Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Lymphoma, Non-Hodgkin Myelodysplastic Syndromes Preleukemia Lymphoma, Large-Cell, Immunoblastic Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
Cyclophosphamide Cyclosporins Cyclosporine Methotrexate Mycophenolate mofetil Sirolimus Tacrolimus Mycophenolic Acid Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating |
ClinicalTrials.gov processed this record on June 17, 2013