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Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Primary Purpose

Leukemia, Lymphoma, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cyclophosphamide
allogeneic bone marrow transplantation
peripheral blood stem cell transplantation
radiation therapy
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II mantle cell lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, meningeal chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, recurrent mycosis fungoides/Sezary syndrome, secondary acute myeloid leukemia, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III mantle cell lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV mantle cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of hematological malignancy, including any of the following: Chronic myeloid leukemia Acute myeloid leukemia Acute lymphocytic leukemia Myelodysplastic syndromes Lymphoma Unlikely to respond to conventional treatment and would benefit from hematopoietic stem cell transplantation No bulky tumor mass requiring additional involved field radiotherapy No large body burden of tumor cells requiring cytoreductive chemotherapy before total body irraditation and cyclophosphamide Undergoing conditioning for transplantation at the University of Washington Medical Center Availability of 1 of the following types of allogeneic donors: HLA-identical family members Unrelated donors Allele match (match grade 1) One allele mismatch for A, B, C, DRB1 or DQB1 (match grades 2.1 or 2.2) PATIENT CHARACTERISTICS: Age 18 to 65 Performance status Not specified Life expectancy Not severely limited by diseases other than malignancy Not moribund Hematopoietic Not specified Hepatic Bilirubin no greater than 1.2 mg/dL No cirrhosis No hepatic fibrosis with bridging Renal Creatinine no greater than 1.2 mg/dL Cardiovascular No coronary artery disease No congestive heart failure requiring therapy Pulmonary Oxygen saturation at least 93% (on room air) Other Not pregnant or nursing Fertile patients must use effective contraception HIV negative No concurrent infection requiring systemic antibiotic or antifungal therapy PRIOR CONCURRENT THERAPY: Biologic therapy No prior hematopoietic stem cell transplantation Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy See Disease Characteristics No prior radiotherapy to the liver or adjacent organs Surgery Not specified Other No concurrent aspirin or nonsteroidal anti-inflammatory medications such as ibuprofen (e.g., Motrin® or Advil®) No other concurrent phase I study enrollment

Sites / Locations

  • Fred Hutchinson Cancer Research Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 5, 2003
Last Updated
September 20, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00062140
Brief Title
Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Official Title
A Phase I Trial Of Total Body Irradiation, Cyclophosphamide Dose-Adjustment Based On Its Metabolism, And Hematopoietic Stem Cell Transplantation For Patients With Hematological Malignancy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Adjusting the dose of drugs used in chemotherapy such as cyclophosphamide may decrease side effects while stopping cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill cancer cells. PURPOSE: Phase I trial to study the effect on the body of dose-adjusted cyclophosphamide combined with total-body irradiation and donor stem cell transplantation in treating patients who have hematologic cancer.
Detailed Description
OBJECTIVES: Determine a safe and reproducible method of adjusting the dose of cyclophosphamide based on its metabolism when given in combination with total body irradiation and hematopoietic stem cell transplantation in patients with hematologic malignancy. OUTLINE: Preparative regimen: Patients undergo total body irradiation twice daily on days -6 to -4. Patients then receive dose-adjusted (based on metabolism) cyclophosphamide IV over 1 hour on days -3 and -2. Hematopoietic stem cell (HSC) infusion: Patients undergo allogeneic HSC transplantation on day 0. Patients receive graft-versus-host disease prophylaxis, CNS prophylaxis, and testicular irradiation as per institutional standard practices. Patients are followed daily until day 80 after transplantation and then regularly thereafter for survival. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases
Keywords
recurrent adult diffuse large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse small cleaved cell lymphoma, recurrent adult Burkitt lymphoma, recurrent adult Hodgkin lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent adult lymphoblastic lymphoma, recurrent cutaneous T-cell non-Hodgkin lymphoma, recurrent grade 1 follicular lymphoma, recurrent grade 2 follicular lymphoma, recurrent grade 3 follicular lymphoma, recurrent mantle cell lymphoma, noncontiguous stage II adult diffuse large cell lymphoma, noncontiguous stage II adult diffuse mixed cell lymphoma, noncontiguous stage II adult Burkitt lymphoma, noncontiguous stage II adult immunoblastic large cell lymphoma, noncontiguous stage II adult lymphoblastic lymphoma, noncontiguous stage II grade 3 follicular lymphoma, noncontiguous stage II mantle cell lymphoma, stage III adult lymphoblastic lymphoma, stage IV adult lymphoblastic lymphoma, stage III adult Burkitt lymphoma, stage IV adult Burkitt lymphoma, recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, chronic phase chronic myelogenous leukemia, meningeal chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes, noncontiguous stage II adult diffuse small cleaved cell lymphoma, noncontiguous stage II grade 1 follicular lymphoma, noncontiguous stage II grade 2 follicular lymphoma, recurrent mycosis fungoides/Sezary syndrome, secondary acute myeloid leukemia, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III adult diffuse small cleaved cell lymphoma, stage III grade 3 follicular lymphoma, stage III adult diffuse large cell lymphoma, stage III adult diffuse mixed cell lymphoma, stage III adult immunoblastic large cell lymphoma, stage III mantle cell lymphoma, stage IV grade 3 follicular lymphoma, stage IV adult diffuse large cell lymphoma, stage IV adult diffuse mixed cell lymphoma, stage IV adult immunoblastic large cell lymphoma, stage IV mantle cell lymphoma, stage IV adult diffuse small cleaved cell lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, recurrent adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, atypical chronic myeloid leukemia, myelodysplastic/myeloproliferative disease, unclassifiable, noncontiguous stage II small lymphocytic lymphoma, noncontiguous stage II marginal zone lymphoma, recurrent marginal zone lymphoma, recurrent small lymphocytic lymphoma, stage III small lymphocytic lymphoma, stage III marginal zone lymphoma, stage IV small lymphocytic lymphoma, stage IV marginal zone lymphoma, extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue, nodal marginal zone B-cell lymphoma, splenic marginal zone lymphoma, adult acute myeloid leukemia with t(8;21)(q22;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with t(15;17)(q22;q12)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Procedure
Intervention Name(s)
allogeneic bone marrow transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of hematological malignancy, including any of the following: Chronic myeloid leukemia Acute myeloid leukemia Acute lymphocytic leukemia Myelodysplastic syndromes Lymphoma Unlikely to respond to conventional treatment and would benefit from hematopoietic stem cell transplantation No bulky tumor mass requiring additional involved field radiotherapy No large body burden of tumor cells requiring cytoreductive chemotherapy before total body irraditation and cyclophosphamide Undergoing conditioning for transplantation at the University of Washington Medical Center Availability of 1 of the following types of allogeneic donors: HLA-identical family members Unrelated donors Allele match (match grade 1) One allele mismatch for A, B, C, DRB1 or DQB1 (match grades 2.1 or 2.2) PATIENT CHARACTERISTICS: Age 18 to 65 Performance status Not specified Life expectancy Not severely limited by diseases other than malignancy Not moribund Hematopoietic Not specified Hepatic Bilirubin no greater than 1.2 mg/dL No cirrhosis No hepatic fibrosis with bridging Renal Creatinine no greater than 1.2 mg/dL Cardiovascular No coronary artery disease No congestive heart failure requiring therapy Pulmonary Oxygen saturation at least 93% (on room air) Other Not pregnant or nursing Fertile patients must use effective contraception HIV negative No concurrent infection requiring systemic antibiotic or antifungal therapy PRIOR CONCURRENT THERAPY: Biologic therapy No prior hematopoietic stem cell transplantation Chemotherapy See Disease Characteristics Endocrine therapy Not specified Radiotherapy See Disease Characteristics No prior radiotherapy to the liver or adjacent organs Surgery Not specified Other No concurrent aspirin or nonsteroidal anti-inflammatory medications such as ibuprofen (e.g., Motrin® or Advil®) No other concurrent phase I study enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George B. McDonald, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States

12. IPD Sharing Statement

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Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer

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