Status:
COMPLETED
High-Dose Busulfan and High-Dose Cyclophosphamide Followed By Donor Bone Marrow Transplant in Treating Patients With Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Recurrent Hodgkin or Non-Hodgkin Lymphoma
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Accelerated Phase Chronic Myelogenous Leukemia
Adult Acute Lymphoblastic Leukemia in Remission
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
RATIONALE: Giving high doses of chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's i...
Detailed Description
OBJECTIVES: I. To determine the toxicity and efficacy of the high-dose chemotherapy regimen which employs busulfan, cyclophosphamide, and allogeneic bone marrow transplantation. II. To ascertain fea...
Eligibility Criteria
Inclusion
- Criteria
- Acute non-lymphocytic leukemia (FAB types M1-M7) in first, or second remission, or early first or second bone or marrow relapse (\>31% marrow blasts and no circulating peripheral blasts)
- All patients with acute promyelocytic leukemia in first complete remission who have received retinoic acid and chemotherapy are not eligible
- Acute lymphocytic leukemia in first or second remission, or early first or second bone marrow relapse (31% marrow blasts and no circulating peripheral blasts)
- Pediatric ALL patients in first complete remission are not eligible
- Chronic myelogenous leukemia in first or second chronic phase, or accelerated phase
- Myelodysplastic syndrome =\< 50 years
- Lymphoma patients age =\< 50 years (non Hodgkins or Hodgkins) in first or second relapse, or refractory disease, who are ineligible for autologous bone marrow transplantation because of tumor in the bone marrow
- Multiple myeloma patients age =\< 50 who have relapsed or are refractory to at least 2 chemo-radiation or chemotherapy regimens
- Patients who have failed a previous allogeneic bone marrow transplant
- Patients with inborn errors of metabolism
- ECOG performance status of 0 or 1
- Karnofsky performance status of \>= 70%
- Patients must be HTLV-III (HIV) anti-body negative
- Acute and chronic leukemia patients must be age =\< 50 years; patients up to age 60 years for any of these diseases who have a syngeneic donor are eligible
- Patients (or bone marrow donors) who are HTLV-III (HIV) antibody positive are ineligible for this study
- Patients must not have active infection
- Patients must not have cytotoxic chemotherapeutic agents for at least 4 weeks before the transplant conditioning regimen is to begin
- It is recommended but not required that acute leukemia patients undergoing transplantation in first remission must have received at least one course of consolidation therapy
- Patients undergoing transplant in early relapse are eligible for transplant in first and second relapse only
- Patients must have no history of acute myocardial infarction in the 6 months prior to transplantation, angina pectoris requiring nitrate therapy, uncontrolled major ventricular dysrhythmia, uncontrolled hypertension, or uncontrolled congestive heart failure
- A gated-pool radionuclide scan fraction must be \>= 50%
- Serum creatinine must be =\< 1.8% and a 24 hour creatinine clearance must be \>= 60ml/min
- Serum direct bilirubin \>= 1.8mg%, or serum SGOT or SGPT \> twice normal will exclude patients from this study
- Severe symptomatic CNS disease of any etiology other than CNS leukemia will exclude patients from study
- FEV1 and DLco (corrected) must be \>= 60% of normal
- pO2 \> 60mmHg
- Insulin-dependent diabetes mellitus or uncompensated major thyroid or adrenal dysfunction render patients ineligible
- Written informed consent must be obtained
- Patients treated previously with radiation therapy in excess of 1000 cGy (rads) to any thoracic or abdominal port, or in excess of 3000 cGy (rads) to cranial-spinal ports, who are not eligible for other protocols are eligible for this study
- DONOR: All genotypically HLA- or D/DR identical siblings are eligible to be bone marrow donors so long as their general medical condition permits the safe use of general or spinal anesthesia; selected donors who are not HLA-identical may be considered for use as long as they are D/DR identical, MLC compatible, and are in good condition to safely undergo spinal or general anesthesia
- DONOR: This protocol will allow the use of donors who are unrelated but are HLA-A, b, C, D/Dr identical and MLC (mixed lymphocyte culture) compatible
- Patient must have adequate insurance to cover the cost of the transplant and hospitalization
Exclusion
Key Trial Info
Start Date :
March 1 1988
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT01177371
Start Date
March 1 1988
End Date
February 1 2010
Last Update
August 9 2010
Active Locations (1)
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1
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106