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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

1990-08-31

Study Completion Date

2003-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Leukemia Lymphoma

Keywords

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stage IV adult Hodgkin lymphoma recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma Waldenstrom macroglobulinemia stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies untreated childhood acute lymphoblastic 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 stage IV childhood Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma recurrent adult non-Hodgkin lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma stage IV childhood small noncleaved cell lymphoma stage IV childhood large cell lymphoma recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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cyclophosphamide

Intervention Type DRUG

allogeneic bone marrow transplantation

Intervention Type PROCEDURE

low-LET cobalt-60 gamma ray therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

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

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Claudio Anasetti, MD

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Anasetti C, Etzioni R, Petersdorf EW, Martin PJ, Hansen JA. Marrow transplantation from unrelated volunteer donors. Annu Rev Med. 1995;46:169-79. doi: 10.1146/annurev.med.46.1.169.

Reference Type BACKGROUND

PMID: 7598453 (View on PubMed)

Petersdorf EW, Longton GM, Anasetti C, Martin PJ, Mickelson EM, Smith AG, Hansen JA. The significance of HLA-DRB1 matching on clinical outcome after HLA-A, B, DR identical unrelated donor marrow transplantation. Blood. 1995 Aug 15;86(4):1606-13.

Reference Type RESULT

PMID: 7632970 (View on PubMed)

Beatty PG, Anasetti C, Hansen JA, Longton GM, Sanders JE, Martin PJ, Mickelson EM, Choo SY, Petersdorf EW, Pepe MS, et al. Marrow transplantation from unrelated donors for treatment of hematologic malignancies: effect of mismatching for one HLA locus. Blood. 1993 Jan 1;81(1):249-53.

Reference Type RESULT

PMID: 8417795 (View on PubMed)

Beatty PG, Hansen JA, Longton GM, Thomas ED, Sanders JE, Martin PJ, Bearman SI, Anasetti C, Petersdorf EW, Mickelson EM, et al. Marrow transplantation from HLA-matched unrelated donors for treatment of hematologic malignancies. Transplantation. 1991 Feb;51(2):443-7. doi: 10.1097/00007890-199102000-00034.

Reference Type RESULT

PMID: 1994541 (View on PubMed)

Other Identifiers

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CDR0000063397

Identifier Type: -

Identifier Source: secondary_id

NCI-H94-0372

Identifier Type: -

Identifier Source: secondary_id

160.06

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Interventions

cyclophosphamide

allogeneic bone marrow transplantation

low-LET cobalt-60 gamma ray therapy

Eligibility Criteria

Inclusion Criteria

Sponsors

National Cancer Institute (NCI)

Fred Hutchinson Cancer Center

Principal Investigators

Claudio Anasetti, MD

Locations

Fred Hutchinson Cancer Research Center

Countries

References

Anasetti C, Etzioni R, Petersdorf EW, Martin PJ, Hansen JA. Marrow transplantation from unrelated volunteer donors. Annu Rev Med. 1995;46:169-79. doi: 10.1146/annurev.med.46.1.169.

Petersdorf EW, Longton GM, Anasetti C, Martin PJ, Mickelson EM, Smith AG, Hansen JA. The significance of HLA-DRB1 matching on clinical outcome after HLA-A, B, DR identical unrelated donor marrow transplantation. Blood. 1995 Aug 15;86(4):1606-13.

Beatty PG, Anasetti C, Hansen JA, Longton GM, Sanders JE, Martin PJ, Mickelson EM, Choo SY, Petersdorf EW, Pepe MS, et al. Marrow transplantation from unrelated donors for treatment of hematologic malignancies: effect of mismatching for one HLA locus. Blood. 1993 Jan 1;81(1):249-53.

Other Identifiers

CDR0000063397

NCI-H94-0372

160.06