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

NCT00112567 | Completed Phase 1

• 3 other identifiers: 1629.00FHCRC-1629.00CDR0000430650
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety

Secondary Outcomes (3)

• Risk of severe graft-versus-host disease

• Kinetics of immune reconstitution

• Risk of life-threatening infections

Interventions

fludarabine phosphate DRUG

thiotepa DRUG

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109-1023, United States

Location

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Accelerated Phase; Blast Crisis

Interventions

fludarabine phosphate; Thiotepa; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Myeloproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes

Intervention Hierarchy (Ancestors)

Phosphoramides; Organophosphorus Compounds; Organic Chemicals; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Ann E. Woolfrey, MD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: April 1, 2003
• Study Completion: July 1, 2007
• Last Updated: September 21, 2010

Record last verified: 2010-09

Locations

US (2)