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Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00006042
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 10, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.

PURPOSE: Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow transplantation in treating patients who have hematologic cancer.


Condition or disease Intervention/treatment Phase
Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Biological: filgrastim Drug: cyclophosphamide Drug: fludarabine phosphate Drug: mycophenolate mofetil Drug: tacrolimus Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy Phase 1

Detailed Description:

OBJECTIVES:

  • Determine the minimum effective dose of pretransplant cyclophosphamide to induce engraftment of haploidentical allogeneic bone marrow without the use of myeloablative conditioning in patients with hematologic malignancies.
  • Determine the incidence and severity of graft versus host disease and nonhematologic toxicities with this treatment regimen in these patients.
  • Correlate the pretreatment phenotypic and functional immunologic characteristics in these patients in relation to risk of graft rejection with this treatment regimen.

OUTLINE: This is a dose-escalation study of cyclophosphamide.

Patients receive fludarabine IV over 1 hour on days -6 to -2; cyclophosphamide IV over 1 hour on days -6, -5, and 3; total body irradiation on day -1; and allogeneic bone marrow transplantation on day 0. Patients also receive tacrolimus IV or orally twice a day on days 4-50; oral mycophenolate mofetil on days 4-35; and filgrastim (G-CSF) subcutaneously or IV starting on day 4 and continuing until blood counts recover.

Cohorts of 3-6 patients receive escalating doses of cyclophosphamide until the minimum effective dose necessary to induce chimerism without unacceptable toxicity in these patients is determined.

Patients are followed at 2 and 6 months, at one year, and then annually thereafter.

PROJECTED ACCRUAL: At least 23 patients will be accrued for this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Non-Myeloablative Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Using Haploidentical Donors: A Phase I Trial of Pre-Transplant Cyclophosphamide
Study Start Date : December 1999

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Patients with any of the following diagnoses:

    • Chronic myelogenous leukemia

      • Chronic phase 1

        • Failed prior interferon alfa therapy OR
        • Relapsed after prior autologous stem cell transplantation
      • Chronic phase 2

    • Acute leukemia

      • Standard risk

        • Age over 60 years
        • Complete remission 1 (CR1)

      • High risk

        • High WBC at presentation, unfavorable cytogenetics, mixed lineage, delayed response to induction chemotherapy
        • CR1
        • Complete remission 2 or higher

    • Acute lymphocytic leukemia

      • CR1 or higher

    • Myelodysplastic syndrome

      • Untreated OR
      • CR1
    • Acute myeloid leukemia in CR1

    • Chronic lymphocytic leukemia

      • Rai stage III or IV OR
      • Received prior autologous stem cell transplantation

    • Multiple myeloma

      • Stage II or III
      • Stable or progressive disease after prior chemotherapy OR
      • Received prior autologous stem cell transplantation
    • Non-Hodgkin's Lymphoma
    • Hodgkin's lymphoma
  • Ineligible for or refused autologous or standard allogeneic bone marrow transplantation
  • Ineligible for bone marrow transplantation from an HLA matched, sibling donor or from an HLA matched, unrelated donor
  • Must have an HLA mismatched, related donor (3-5 out of 6)

PATIENT CHARACTERISTICS:

Age:

  • 0.5 to 70

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin less than 3.1 mg/dL

Renal:

  • Not specified

Cardiovascular:

  • Left ventricular ejection fraction at least 35%

Pulmonary:

  • FEV_1 and FVC at least 40% of predicted OR
  • FEV_1 and FVC at least 60% in patients who have received prior thoracic or mantle radiotherapy

Other:

  • HIV negative
  • No other debilitating medical or psychiatric illness that would preclude study compliance
  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No prior transfusions from donor

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • Not specified
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006042


Locations
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United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
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Study Chair: Ephraim J. Fuchs, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00006042    
Other Study ID Numbers: CDR0000068057, J9966
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J9966
JHOC-99110501
NCI-G00-1816
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: March 10, 2010
Last Verified: March 2010
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
recurrent adult Hodgkin lymphoma
Burkitt lymphoma
refractory multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
recurrent childhood lymphoblastic lymphoma
stage III chronic lymphocytic leukemia
stage IV chronic lymphocytic leukemia
relapsing chronic myelogenous leukemia
refractory chronic lymphocytic leukemia
chronic phase chronic myelogenous leukemia
adult acute myeloid leukemia in remission
adult acute lymphoblastic leukemia in remission
childhood acute myeloid leukemia in remission
childhood acute lymphoblastic leukemia in remission
 recurrent/refractory childhood Hodgkin lymphoma
stage II adult lymphoblastic lymphoma
stage III grade 3 follicular lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III adult Burkitt lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Syndrome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions
Mycophenolic Acid
Cyclophosphamide
Fludarabine
Fludarabine phosphate