Status:
UNKNOWN
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Myeloproliferative Disorders
Kidney Cancer
Eligibility:
All Genders
Up to 74 years
Phase:
NA
Brief Summary
RATIONALE: Giving low doses of chemotherapy before a donor stem cell transplant using stem cells that closely match the patient's stem cells, helps stop the growth of cancer cells. It also stops the p...
Detailed Description
OBJECTIVES: Primary * Determine the treatment-related mortality (TRM) rate at 100 days in patients with hematologic malignancy, metastatic renal cell carcinoma, or aplastic anemia undergoing nonmyel...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Aplastic anemia not responsive to immunosuppressive therapy
- Metastatic renal cell carcinoma
- Hematologic malignancy, including any of the following:
- Acute myeloid leukemia (AML)\* not curable with chemotherapy and meeting any of the following criteria:
- AML with high-risk cytogenetic abnormalities (e.g., -7, -7q, -5, -5q, complex, Philadelphia chromosome-positive \[Ph+\])
- AML evolved from prior myelodysplasia
- AML secondary to prior chemotherapy
- Failed to achieve remission
- In second or subsequent remission NOTE: \*Marrow blasts \< 10%- can be achieved by chemotherapy
- Myelodysplasia\* with any of the following high-risk features:
- Adverse cytogenetics (-7, 7q, -5, -5q, complex)
- Excess blasts
- Prior conversion to AML
- Severe cytopenias with absolute neutrophil count \< 500/mm\^3 or platelet count \< 20,000/mm\^3 NOTE: \*Marrow blasts \< 10%- can be achieved by chemotherapy
- Acute lymphoblastic leukemia (ALL)\* not curable with chemotherapy and meeting any of the following criteria:
- High-risk cytogenetics (Ph+, 11q23 abnormalities, monosomy 7)
- More than 1 induction course required to achieve remission
- Failed to enter remission
- In second or subsequent remission NOTE: \*Marrow blasts \< 10 %
- Chronic lymphocytic leukemia (CLL) with high-risk features, including any of the following:
- Refractory to initial or subsequent therapy
- Progression after initial response to therapy
- Prolymphocytic morphology
- Follicular lymphoma with any of the following high-risk features:
- Refractory to initial or subsequent therapy
- Progression after response to initial therapy
- Has ≥ 3 International Prognostic Index (IPI) risk factors
- Multiple myeloma
- Stage II-III disease confirmed at diagnosis or after initial progression
- Other lymphoma that has failed to respond to primary therapy, progressed, or recurred after prior therapy, including any of the following:
- Diffuse large cell lymphoma
- Mantle cell lymphoma
- Hodgkin's lymphoma
- Myeloproliferative disease with evidence of disease acceleration, including any of the following:
- Myelofibrosis
- Polycythemia vera
- Essential thrombocythemia
- Chronic myeloid leukemia (CML) that failed to be controlled by imatinib mesylate
- Disease must be stable or responding to therapy
- No rapid progression of malignant disease
- Expected time to disease progression \> 12 weeks
- Not eligible for autologous stem cell transplantation
- Matched unrelated donor available
- 9/10 HLA matched, including HLA-A, -B, -C, -DR, and -DQ
- PATIENT CHARACTERISTICS:
- Creatinine \< 2.0 mg/dL
- Creatinine clearance \> 40 mL/min
- Bilirubin \< 3 mg/dL
- Elevated total bilirubin due to Gilbert's disease allowed if direct bilirubin is normal
- AST \< 4 times upper limit of normal
- Hepatitis C or B allowed provided bilirubin and AST are normal
- Cardiac ejection fraction \> 30%
- DLCO \> 40% of predicted
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No uncontrolled active infection requiring ongoing antibiotic treatment
- No poor performance status
- No poor organ function
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior stem cell or bone marrow transplantation allowed
Exclusion
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00295997
Start Date
May 1 2005
Last Update
January 6 2014
Active Locations (2)
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1
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
2
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096