Donor Stem Cell Transplantation in Treating Patients With Hematologic Cancer
This study is currently recruiting patients.
Sponsored by: |
Ireland Cancer Center
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation
therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy and radiation therapy with donor stem cell
transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation to kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of chemotherapy with or without radiation therapy followed by donor stem
cell transplantation in treating patients who have hematologic cancer.
Condition
|
Treatment or Intervention |
Phase |
childhood non-Hodgkin's lymphoma Leukemia Lymphoma myelodysplastic and myeloproliferative diseases
|
Drug: busulfan Drug: cyclophosphamide Drug: cytarabine Procedure: allogeneic bone marrow transplantation Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: bone marrow transplantation Procedure: chemotherapy Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy
|
Phase II
|
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Hematopoietic Stem Cell Transplantation Using Matched Unrelated Donors in Patients With Hematologic Malignancies
Further Study Details:
OBJECTIVES:
- Determine a standard approach to hematopoietic stem cell transplantation with matched unrelated donors in patients with hematologic
malignancies.
- Determine the toxicity of this regimen in these patients.
- Determine the relapse rate and survival rate in patients treated with this regimen.
- Correlate incidence and severity of graft-versus-host disease with relapse and survival in patients treated with this regimen.
OUTLINE: Patients receive 1 of the following preparative regimens:
- Regimen A: Patients receive cytarabine IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide IV over 2 hours on
days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1.
- Regimen B: Patients receive cyclophosphamide IV and TBI as in regimen A.
- Regimen B2: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on
days -3 to -1.
- Regimen C: Patients receive oral busulfan 4 times daily on days -8 to -5 and cyclophosphamide IV over 2 hours on days -4 to
-2. All patients undergo stem cell transplantation from a matched, unrelated donor on day 0.
Patients are followed weekly for 100 days, at 6 months, and then every 6 months for 2.5 years.
PROJECTED ACCRUAL: Not specified
Eligibility
Ages Eligible for Study:
up to 55 Years,
Genders Eligible for Study:
Both
DISEASE CHARACTERISTICS:
- One of the following histologically confirmed diseases:
- Acute myeloid leukemia (AML)
- In first, second, or greater remission
- In early relapse (less than 30% marrow blasts)
- Acute lymphoblastic leukemia (ALL)
- In second or greater complete remission
- High-risk ALL in first complete remission, defined by 1 of the following factors:
- t(4;11), t(9;22), or t(8;14) translocation
- Extreme hyperleukocytosis (WBC greater than 500,000/mL) at presentation
- Failure to achieve a complete remission after standard induction therapy
- Chronic myelogenous leukemia
- Myelodysplastic syndromes
- Evolution to AML included
- Refractory anemia with excess blasts (RAEB)
- RAEB in transformation
- Intermediate or high-grade lymphoma
- Complete response (CR) or partial response (PR) after first or greater relapse OR
- PR only after first-line therapy NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ.
The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high"
grade lymphoma. However, this protocol uses the former terminology.
PATIENT CHARACTERISTICS: Age
Performance status
- ECOG 0-2 OR
- Lansky 80-100%
Life expectancy
Hematopoietic
- See Disease Characteristics
Hepatic
- Bilirubin less than 2.5 mg/dL
- AST less than 4 times upper limit of normal
- No chronic active hepatitis
Renal
- Creatinine no greater than 2.0 mg/dL
- Creatinine clearance at least 50 mL/min by 24-hour urine collection
Cardiovascular
- Resting ejection fraction at least 50%
- Shortening fraction greater than 28% (for small children)
- No angina requiring treatment
- No congestive heart failure requiring treatment
- No myocardial infarction within the past year
Pulmonary
- FEV_1 at least 50% of predicted
- Arterial partial pressure of oxygen at least 80 mm Hg by pulmonary function testing
- Diffusion capacity at least 50% of predicted
Other
- Not pregnant or nursing
- Negative pregnancy test
- HIV negative
- No uncontrolled diabetes mellitus
- No active infection, including any of the following:
- Soft tissue infection
- Sinus infection
- Dental infection
- Fungal infection
- No significant psychiatric illness that would preclude study participation
- No medical complication that makes the risk of death during transplantation from nonmalignant causes greater than the risk
of relapse
PRIOR CONCURRENT THERAPY: Biologic therapy
- At least 1 year since prior stem cell transplantation
Chemotherapy
- See Disease Characteristics
Endocrine therapy
Radiotherapy
Surgery
Location
and Contact
Information
Ohio Ireland Cancer Center, Cleveland,
Ohio,
44106-5065,
United States; Recruiting
Study chairs or principal investigators
Michael L. Nieder, MD, Study Chair, Ireland Cancer Center
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000270380; CWRU-1Y00
Record last reviewed:
January 2003
Record first received:
February 5, 2003
ClinicalTrials.gov Identifier:
NCT00054327Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-18