Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: UCSF Helen Diller Family Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00295997
  Purpose

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 patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening.

PURPOSE: This clinical trial is studying how well a donor stem cell transplant works in treating patients with hematologic cancer, metastatic kidney cancer, or aplastic anemia.


Condition Intervention
Chronic Myeloproliferative Disorders
Kidney Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Drug: anti-thymocyte globulin
Drug: busulfan
Drug: cyclophosphamide
Drug: filgrastim
Drug: fludarabine phosphate
Drug: methotrexate
Drug: mycophenolate mofetil
Drug: tacrolimus
Drug: therapeutic allogeneic lymphocytes
Procedure: allogeneic bone marrow transplantation
Procedure: graft-versus-tumor induction therapy
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Procedure: peripheral blood stem cell transplantation

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Anemia Bone Marrow Transplantation Cancer Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma
Drug Information available for: Cyclophosphamide Filgrastim Methotrexate Fludarabine Fludarabine monophosphate Tacrolimus Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Tacrolimus anhydrous Busulfan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Non-Myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 35
Study Start Date: May 2005
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 nonmyeloablative allogeneic stem cell transplantation using matched unrelated donors.

Secondary

  • Determine the TRM at 12 months in patients treated with this regimen.
  • Determine the 6-month engraftment rate in patients treated with this regimen.
  • Determine 1-year overall survival of patients treated with this regimen.

OUTLINE:

  • Nonmyeloablative preparative regimen: Patients receive fludarabine IV over 30 minutes on days -7 to -3, busulfan* IV over 6 hours on days -4 and -3, and anti-thymocyte globulin IV over 6-10 hours on days -4 to -1.

NOTE: *Patients with aplastic anemia receive cyclophosphamide IV over 2 hours on days -6 to -3 instead of busulfan.

  • Allogeneic stem cell reinfusion: Patients undergo allogeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients then receive filgrastim (G-CSF) subcutaneously daily beginning on day 7 and continuing until blood counts recover.
  • Graft-vs-host disease (GVHD) prophylaxis: Patients receive tacrolimus orally twice daily or IV continuously beginning on day -2 and continuing for approximately for 6-12 months after transplantation. Patients also receive mycophenolate mofetil orally or IV twice daily on days 0 to 60 and methotrexate IV on days 1, 3, 6, and 11**.

NOTE: **Patients with aplastic anemia receive methotrexate IV on days 1, 3, and 6 (not day 11).

  • Donor lymphocyte infusion (DLI): After day 180, patients with no evidence of active GVHD may receive DLI. A second DLI may be infused > 8 weeks after the first in the absence of disease response or GVHD.

After completion of study treatment, patients are followed periodically for at least 2 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   up to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00295997

Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
UCSF Helen Diller Family Comprehensive Cancer Center
Investigators
Principal Investigator: Charles A. Linker, MD UCSF Helen Diller Family Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000463522, UCSF-01251, UCSF-H5010-19585-05, UCSF-2101
Study First Received: February 23, 2006
Last Updated: November 16, 2008
ClinicalTrials.gov Identifier: NCT00295997  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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)
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
childhood acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
essential thrombocythemia
juvenile myelomonocytic leukemia
myelodysplastic/myeloproliferative disease, unclassifiable
polycythemia vera
previously treated myelodysplastic syndromes
recurrent adult acute myeloid leukemia
prolymphocytic leukemia
recurrent adult Hodgkin lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent/refractory childhood Hodgkin lymphoma

Study placed in the following topic categories:
Blast Crisis
Chronic myelogenous leukemia
Hodgkin lymphoma, adult
Urogenital Neoplasms
Tacrolimus
Lymphoma, large-cell, immunoblastic
Preleukemia
Leukemia, Prolymphocytic
Hemorrhagic Disorders
Hemorrhagic thrombocythemia
Neoplasm Metastasis
Thrombocythemia, Hemorrhagic
Methotrexate
Kidney Diseases
Myelodysplastic syndromes
Essential thrombocytosis
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Leukemia, Myelomonocytic, Chronic
Blood Coagulation Disorders
Acute myelogenous leukemia
Leukemia, Myeloid
Carcinoma
Folic Acid
Myelodysplastic myeloproliferative disease
Leukemia, Myeloid, Accelerated Phase
Fludarabine
Neoplasms, Glandular and Epithelial
Precancerous Conditions

Additional relevant MeSH terms:
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Pathologic Processes
Neoplasms by Site
Syndrome
Therapeutic Uses
Abortifacient Agents
Cardiovascular Diseases
Alkylating Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Disease
Neoplasms by Histologic Type
Immune System Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents

ClinicalTrials.gov processed this record on January 16, 2009