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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062140
• Other study ID #: 1797.00
• Secondary ID: FHCRC-1797.00CDR
• Status: Completed
• Phase: Phase 1
• First received: June 5, 2003
• Last updated: September 20, 2010
• Start date: April 2003
• Est. completion date: July 2004

Study information

• Verified date: September 2010
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders
• Preleukemia

Intervention

Drug:
• cyclophosphamide

Procedure:
• allogeneic bone marrow transplantation

• peripheral blood stem cell transplantation

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,