Know Cancer

or
forgot password

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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Leukemia, Lymphoma, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Diseases

Thank you

Trial Information

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


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.

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., MotrinĀ® or AdvilĀ®)

- No other concurrent phase I study enrollment

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

George B. McDonald, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1797.00

NCT ID:

NCT00062140

Start Date:

April 2003

Completion Date:

July 2004

Related Keywords:

  • Leukemia
  • Lymphoma
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Diseases
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent adult Hodgkin lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV adult Burkitt lymphoma
  • recurrent adult acute myeloid leukemia
  • untreated adult acute myeloid leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • chronic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II grade 1 follicular lymphoma
  • noncontiguous stage II grade 2 follicular lymphoma
  • recurrent mycosis fungoides/Sezary syndrome
  • secondary acute myeloid leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV mantle cell lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • recurrent adult acute lymphoblastic leukemia
  • untreated adult acute lymphoblastic leukemia
  • atypical chronic myeloid leukemia
  • myelodysplastic/myeloproliferative disease, unclassifiable
  • noncontiguous stage II small lymphocytic lymphoma
  • noncontiguous stage II marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • stage III small lymphocytic lymphoma
  • stage III marginal zone lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Lymphoma, Large-Cell, Immunoblastic
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109