Chemotherapy Plus Radiation Therapy and Biological Therapy in Treating Patients With Hematologic Cancer

Sponsor
Fred Hutchinson Cancer Research Center (Other)
Overall Status
Completed
CT.gov ID
NCT00002553
Collaborator
National Cancer Institute (NCI) (NIH)
50
Enrollment
1
Location
154
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation using unrelated bone marrow donors in treating patients who have hematologic cancer.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: cyclophosphamide
  • Procedure: allogeneic bone marrow transplantation
  • Radiation: low-LET cobalt-60 gamma ray therapy
Phase 2

Detailed Description

OBJECTIVES: I. Determine whether the use of donors with a one non crossreactive group (CREG) mismatch for HLA-A or B in patients less than 36 years of age is associated with more frequent graft versus host disease (GVHD) of grades III-IV than previously observed with donors with one CREG mismatch. II. Determine whether the use of donors with a one CREG mismatch for HLA-A or B in patients 36-50 years of age is associated with more frequent GVHD of grades III-IV than previously observed with matched donors. III. Determine the relevance of HLA-A allele mismatching in bone marrow transplants from donors matched for HLA-A, B, and DR phenotypes.

OUTLINE: This is a parallel, open label study. Patients are assigned to 1 of 3 treatment arms. Arm I: Patients receive cyclophosphamide IV on days -7 and -6 and total body irradiation (TBI) 3 times a day on days -4 through -1. Allogeneic bone marrow (ABM) is infused on day 0. Arm II: Patients receive therapy as in arm I, except TBI is administered twice a day on day -1 only. ABM is infused on day 0. Arm III: Patients receive cyclophosphamide IV on days -6 and -5 and TBI twice a day on days -3 through -1. ABM is infused on day 0. Males with ALL receive an additional radiation boost to the testes during TBI. Patients are followed at least every 6 months for 2 years, then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients under 36 years old and 50 patients 36-50 years old will be accrued for this study within 5 years. Additional patients will be accrued for the standard therapy arm of this study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Primary Purpose:
Treatment
Official Title:
TREATMENT OF PATIENTS WITH HEMATOLOGIC MALIGNANCIES USING MARROW TRANSPLANTATION FROM UNRELATED DONORS MATCHED FOR HLA OR INCOMPATIBLE FOR ONE HLA LOCUS ANTIGEN
Study Start Date :
Aug 1, 1990
Actual Study Completion Date :
Jun 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    DISEASE CHARACTERISTICS: Hematologic malignancies of the following types: Chronic myelogenous leukemia (CML) in chronic or accelerated phase Newly diagnosed acute leukemia at high risk of relapse following chemotherapy alone Early referral encouraged so that donor search can begin as soon as possible Acute leukemia failing one cycle of induction chemotherapy Acute leukemia beyond first remission High-risk Hodgkin's disease and non-Hodgkin's lymphoma in first remission Hodgkin's disease, non-Hodgkin's lymphoma, or other malignant lymphoproliferative disease after first remission No suitable related donor available (i.e., no HLA genotypically identical sibling) No haploidentical relative with no more than 1 unshared haplotype for an HLA-A, -B, or -D locus Acute leukemia in relapse and CML in blast crisis eligible only under the following conditions: Patient's clinical condition is likely to remain stable for the 2-6 month period necessary to find a marrow donor Remission induction has been attempted Local physician and patient accept that the search or transplant may be canceled if the patient's condition deteriorates during the search No leukoencephalopathy Donor requirements: Age less than 60 In good health Phenotypically identical for HLA-A, -B, and -DRB1 1-antigen mismatch for HLA-A, -B, or -DRB1 locus allowed for patients below age 36 Patients for whom TBI is contraindicated may be treated on protocol FHCRC-739 Severe aplastic anemia should be transplanted according to protocols FHCRC-174.2 or FHCRC-800 Myelodysplastic syndrome should be transplanted according to protocol FHCRC-179.3 or FHCRC-844

    PATIENT CHARACTERISTICS: Age: Under 56 Performance status: Not specified Life expectancy:

    Not specified Hematopoietic: Not specified Hepatic: No acute hepatitis No other severe hepatic disease Renal: Creatinine less than 2 times normal for age, weight, and sex Cardiovascular: No symptomatic cardiac disease Pulmonary: No active pulmonary disease No history of pulmonary fibrosis No severe hypoxemia (pO2 less than 70 mm Hg and DLCO less than 70%) No mild hypoxemia (pO2 less than 80 mm Hg and DLCO less than 60%) Other: HIV negative No severe limitations due to diseases other than malignancy

    PRIOR CONCURRENT THERAPY: No more than 3,000 cGy to the whole brain No more than 1,500 cGy to the chest or abdomen At least 6 months since involved-field irradiation to the chest or abdomen

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Fred Hutchinson Cancer Research CenterSeattleWashingtonUnited States98109

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Research Center
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Claudio Anasetti, MD, Fred Hutchinson Cancer Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00002553
    Other Study ID Numbers:
    • 160.06
    • CDR0000063397
    • NCI-H94-0372
    First Posted:
    Apr 26, 2004
    Last Update Posted:
    Nov 30, 2011
    Last Verified:
    Nov 1, 2011
    Keywords provided by , ,
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 30, 2011