Expired Study
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Philadelphia, Pennsylvania 19111


Purpose:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy together with bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bone marrow transplant from an unrelated donor together with cyclophosphamide and total-body irradiation works in treating patients with hematologic cancer.


Study summary:

OBJECTIVES: - Study the curative potential of high-dose cyclophosphamide and total-body irradiation followed by rescue with bone marrow from volunteer HLA-matched donors in patients with a variety of hematologic malignancies and bone marrow failure states. - Study the toxic effects associated with matched unrelated bone marrow transplantation in this patient population. - Participate in collaborative research studies with the National Marrow Donor Program. OUTLINE: All patients receive myeloablative therapy with high-dose cyclophosphamide and total body irradiation over 4 days; patients with severe aplastic anemia also receive antithymocyte globulin. Patients then undergo allogeneic bone marrow transplantation. Filgrastim (G-CSF) is given after transplant to accelerate engraftment. Sargramostim (GM-CSF) may be given in case of graft failure. All patients receive graft-versus-host-disease (GVHD) prophylaxis with tacrolimus, methotrexate, and gamma globulin. Established GVHD is treated with corticosteroids and, as necessary, antithymocyte globulin. Patients are followed at 100 days, 6 months, and 1 year after transplant, then annually thereafter. PROJECTED ACCRUAL: A total of 10 patients per year will be accrued for this study over 5 years.


Criteria:

DISEASE CHARACTERISTICS: - One of the following hematologic malignancies/disorders: - Acute lymphoblastic leukemia - In second or subsequent complete remission (CR) - In first CR with high-risk features (e.g., Philadelphia chromosome-positive) - In first relapse and failed conventional salvage therapy - Acute myelogenous leukemia (AML) - In second or subsequent CR - In early first relapse - In full first relapse and failed conventional salvage therapy - In first CR with high-risk features, e.g., trisomy 8 or FAB 6/7 - Standard-risk AML offered conventional-dose consolidation chemotherapy or autologous bone marrow transplantation - Chronic myelogenous leukemia in chronic, accelerated, or second chronic phase - No blast crisis - Severe aplastic anemia that has failed at least 1 course of immunosuppressive therapy - Paroxysmal nocturnal hemoglobinuria with high-risk features (e.g., disseminated intravascular coagulation, thrombotic events) - Myelodysplastic syndrome, i.e.: - Symptomatic, transfusion-dependent refractory anemia with excess blasts - (RAEB) or RAEB in transformation - Secondary leukemia in CR following conventional-dose induction chemotherapy - Unrelated marrow donor available who is 8 out of 10-, 9 out of 10-, or 10 out of 10-antigen serologically HLA-matched at A, B, C, DRb, and DQB loci by molecular typing - No CNS malignancy PATIENT CHARACTERISTICS: Age: - 17 to 60 Performance status: - Karnofsky 70-100% Life expectancy: - No reduction due to other serious illness Hematopoietic: - Not specified Hepatic: - Bilirubin less than 3 mg/dL - AST/ALT no greater than twice normal Renal: - Creatinine no greater than 2.0 mg/dL - Creatinine clearance greater than 60 mL/min Cardiovascular: - Left ventricular ejection fraction at least 45% - No severe hypertension Pulmonary: - DLCO, FEV_1, and FVC at least 50% Other: - HIV negative - No active infection at time of transplant - No advanced diabetes - No significant neurologic deficit - No active drug or substance abuse - No emotional disorders - Able to participate in frequent medical care for at least 1-2 years - Willing to comply with National Marrow Donor Program policies PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics Chemotherapy - See Disease Characteristics Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified


Study is Available At:


Original ID:

CDR0000064937


NCT ID:

NCT00002809


Secondary ID:

TUHSC-2803


Study Acronym:


Brief Title:

Bone Marrow Transplant Plus Cyclophosphamide and Total-Body Irradiation in Treating Patients With Hematologic Cancer


Official Title:

Unrelated Bone Marrow Transplantation With Cyclophosphamide and Total Body Irradiation For Hematologic Malignancies and Bone Marrow Failure States


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

17 Years


Maximum Age:

60 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Temple University


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Masking: Open Label, Primary Purpose: Treatment


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Kenneth F. Mangan, MD, FACP
Study Chair
Fox Chase Cancer Center

Study Dates

Start Date:August 1996
Completion Date:December 2003
Completion Type:Actual
Primary Completion Date:December 2003
Primary Completion Type:Actual
Verification Date:September 2010
Last Changed Date:September 30, 2010
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:anti-thymocyte globulin
Intervention Type:Biological
Name:filgrastim
Intervention Type:Biological
Name:sargramostim
Intervention Type:Biological
Name:therapeutic immune globulin
Intervention Type:Drug
Name:cyclophosphamide
Intervention Type:Drug
Name:methotrexate
Intervention Type:Drug
Name:tacrolimus
Intervention Type:Procedure
Name:allogeneic bone marrow transplantation
Intervention Type:Radiation
Name:radiation therapy

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Temple University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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