Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 to 65 NCI FHCRC-1797.00 NCT00062140

Objectives

1. 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.

Entry 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)

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

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

Expected Enrollment

A total of 20 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Fred Hutchinson Cancer Research Center

George McDonald, MD, Protocol chair		Ph: 206-667-5211

Registry Information
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
Trial Start Date		2003-04-17
Registered in ClinicalTrials.gov		NCT00062140
Date Submitted to PDQ		2003-04-29
Information Last Verified		2004-10-18
NCI Grant/Contract Number		P30-CA15704, P01-CA18029

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