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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2004-07-31

Brief Summary

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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

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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.

Conditions

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Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cyclophosphamide

Intervention Type DRUG

allogeneic bone marrow transplantation

Intervention Type PROCEDURE

peripheral blood stem cell transplantation

Intervention Type PROCEDURE

radiation therapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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George B. McDonald, MD

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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FHCRC-1797.00

Identifier Type: -

Identifier Source: secondary_id

CDR0000304522

Identifier Type: REGISTRY