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Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

Primary Purpose

Leukemia, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
fludarabine phosphate
thiotepa
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 childhood acute lymphoblastic leukemia, childhood myelodysplastic syndromes, childhood acute lymphoblastic leukemia in remission, recurrent childhood acute myeloid leukemia, childhood acute myeloid leukemia in remission, secondary acute myeloid leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, previously treated myelodysplastic syndromes

Eligibility Criteria

undefined - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of a life-threatening hematologic malignancy, including any of the following: Acute leukemia advanced beyond first remission Acute leukemia in first remission* with very high-risk prognostic features, including any of the following: Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) ALL or acute myeloid leukemia (AML) with 11q23 chromosomal abnormality Hypodiploid ALL Failed to achieve first remission within 1 month after induction therapy Secondary AML Myelodysplastic syndromes with International Prognostic Index score > 1 Chronic myelogenous leukemia in accelerated or blast phase NOTE: *Must be approved by PCC Haploidentical family donor available No suitable HLA-matched related or unrelated donor available No related donor mismatched for a single HLA-A, -B, -C, -DRB1, or -DQB1 antigen available PATIENT CHARACTERISTICS: Age Under 21 Performance status Not specified Life expectancy At least 6 months Hematopoietic Not specified Hepatic SGPT and SGOT < 2 times upper limit of normal (ULN)* Bilirubin < 2 times ULN* NOTE: *Unless due to malignancy Renal Not specified Cardiovascular Ejection fraction ≥ 45% Pulmonary DLCO ≥ 60% of predicted Other Not pregnant or nursing Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy No second bone marrow transplantation, after a first regimen containing total body irradiation No concurrent growth factors until day 21 post-transplantation Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy See Biologic therapy Surgery Not specified

Sites / Locations

  • Fred Hutchinson Cancer Research Center
  • Seattle Cancer Care Alliance

Outcomes

Primary Outcome Measures

Safety

Secondary Outcome Measures

Risk of severe graft-versus-host disease
Kinetics of immune reconstitution
Risk of life-threatening infections

Full Information

First Posted
June 2, 2005
Last Updated
September 17, 2010
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00112567
Brief Title
Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer
Official Title
A Phase I/II Study of Total Body Irradiation, Thiotepa, and Fludarabine as Conditioning for Haploidentical CD34+ Purified Peripheral Blood Stem Cell Transplants
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 2007 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Chemotherapy, such as fludarabine and thiotepa, and radiation therapy may destroy cancerous blood-forming cells (stem cells) in the blood and bone marrow. Giving healthy stem cells from a donor whose blood closely resembles the patient's blood will help the patient's bone marrow make new stem cells that become red blood cells, white blood cells, and platelets. PURPOSE: This phase I/II trial is studying the side effects of total-body irradiation, fludarabine, and thiotepa and to see how well they work in treating young patients who are undergoing a donor stem cell transplant for hematologic cancer.
Detailed Description
OBJECTIVES: Primary Determine the safety of a conditioning regimen without anti-thymocyte globulin comprising total body irradiation, thiotepa, and fludarabine followed by CD34-positive-selected haploidentical allogeneic peripheral blood stem cell transplantation in young patients with life-threatening hematologic malignancies. Secondary Determine the risk for severe graft-vs-host disease in patients treated with this regimen. Determine the kinetics of immune reconstitution in patients treated with this regimen. Determine the risk for life-threatening infections in patients treated with this regimen. OUTLINE: Conditioning regimen: Patients 7 years of age and under undergo total body irradiation twice daily on days -9 to -7. Patients over 7 years of age undergo total body irradiation once on day -7. All patients receive fludarabine IV once daily on days -6 to -2 and thiotepa IV over 2 hours twice on day -5. CD34-positive (CD34+)-selected haploidentical allogeneic peripheral blood stem cell transplantation (PBSCT): Patients undergo CD34+-selected allogeneic PBSCT on days 0 and 2. Patients with acute lymphoblastic leukemia or CNS disease also receive methotrexate intrathecally twice before transplantation and 4 times after day 35 post-transplantation. Male patients with lymphoid malignancies undergo additional radiotherapy to the testes. After completion of study treatment, patients are followed for at least 100 days, at 1 year, and then periodically thereafter. PROJECTED ACCRUAL: A total of 20 patients (10 patients ≤ 7 years of age and 10 patients > 7 years of age) will be accrued for this study within 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
recurrent childhood acute lymphoblastic leukemia, childhood myelodysplastic syndromes, childhood acute lymphoblastic leukemia in remission, recurrent childhood acute myeloid leukemia, childhood acute myeloid leukemia in remission, secondary acute myeloid leukemia, accelerated phase chronic myelogenous leukemia, blastic phase chronic myelogenous leukemia, childhood chronic myelogenous leukemia, relapsing chronic myelogenous leukemia, de novo myelodysplastic syndromes, secondary myelodysplastic syndromes, previously treated myelodysplastic syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
None (Open Label)
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Drug
Intervention Name(s)
thiotepa
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Safety
Secondary Outcome Measure Information:
Title
Risk of severe graft-versus-host disease
Title
Kinetics of immune reconstitution
Title
Risk of life-threatening infections

10. Eligibility

Sex
All
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of a life-threatening hematologic malignancy, including any of the following: Acute leukemia advanced beyond first remission Acute leukemia in first remission* with very high-risk prognostic features, including any of the following: Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) ALL or acute myeloid leukemia (AML) with 11q23 chromosomal abnormality Hypodiploid ALL Failed to achieve first remission within 1 month after induction therapy Secondary AML Myelodysplastic syndromes with International Prognostic Index score > 1 Chronic myelogenous leukemia in accelerated or blast phase NOTE: *Must be approved by PCC Haploidentical family donor available No suitable HLA-matched related or unrelated donor available No related donor mismatched for a single HLA-A, -B, -C, -DRB1, or -DQB1 antigen available PATIENT CHARACTERISTICS: Age Under 21 Performance status Not specified Life expectancy At least 6 months Hematopoietic Not specified Hepatic SGPT and SGOT < 2 times upper limit of normal (ULN)* Bilirubin < 2 times ULN* NOTE: *Unless due to malignancy Renal Not specified Cardiovascular Ejection fraction ≥ 45% Pulmonary DLCO ≥ 60% of predicted Other Not pregnant or nursing Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy No second bone marrow transplantation, after a first regimen containing total body irradiation No concurrent growth factors until day 21 post-transplantation Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy See Biologic therapy Surgery Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann E. Woolfrey, MD
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1023
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Total-Body Irradiation, Thiotepa, and Fludarabine in Treating Young Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

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