Status:
TERMINATED
Total Marrow and Total Lymph Node Irradiation, Fludarabine, and Melphalan Followed By Donor Stem Cell Transplant in Treating Patients With Advanced Hematological Cancer That Has Not Responded to Treatment
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Leukemia
Eligibility:
All Genders
16+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Giving total marrow and total lymph node irradiation together with low doses of chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It may also stop the ...
Detailed Description
OBJECTIVES: Primary * To determine the maximum tolerated dose of intensity-modulated total marrow and lymph node irradiation (TMLI) using helical tomotherapy in combination with a reduced-intensity ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histopathologically confirmed diagnosis of 1 of the following:
- Acute myeloid leukemia (AML)
- Myelodysplastic syndromes
- Intermediate- or high-risk disease
- Myelofibrosis
- Granulocytic sarcoma (chloroma)
- With or without bone marrow involvement
- Mixed lineage leukemia
- Induction therapy must have been directed predominantly against AML
- Acute lymphoblastic leukemia
- Non-Hodgkin lymphoma
- Multiple myeloma
- Relapsed or refractory disease with M3 marrow (marrow blasts \> 25%), meeting 1 of the following criteria:
- Persistent disease after an induction attempt
- Persistent initial disease after two induction attempts
- Relapse after one re-induction attempt (second relapse)
- Persistent disease after first relapse and initial re-induction attempt
- Not eligible for myeloablative allogeneic hematopoietic stem cell transplantation due to age (\> 50 years), organ insufficiency, or significant comorbidity
- Patients 16-50 years of age must meet ≥ 1 of the following criteria:
- Ejection fraction 50-60% by MUGA scan and/or echocardiogram
- DLCO 50-75% of predicted
- Creatinine clearance or GFR 60-80 mL/min
- Serum bilirubin ≤ 2.0 mg/dL
- SGOT and SGPT 1.5-5 times upper limit of normal
- No other medical and/or psychosocial problem that, in the opinion of the primary physician or principal investigator, would place the patient at unacceptable risk from study regimen
- No Fanconi anemia
- HLA-identical sibling OR matched unrelated donor available
- PATIENT CHARACTERISTICS:
- Zubrod or Karnofsky performance status 70-100%
- Negative pregnancy test
- Able to lie supine in a full body cast for 30 minutes
- No HIV infection
- No evidence of active hepatitis B or C infection
- No evidence of cirrhosis
- No uncontrolled viral, bacterial, or fungal infection within the past 4 weeks
- No radiographic changes indicating pulmonary disease (e.g., pulmonary nodules, infiltrates, or pleural effusion) unless cleared by pulmonary biopsy that shows no evidence of active pulmonary disease
- No major medical or psychiatric disorder that would seriously compromise patient tolerance of study regimen
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiation therapy
Exclusion
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00800150
Start Date
November 1 2008
End Date
October 1 2010
Last Update
June 8 2015
Active Locations (1)
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1
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000