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

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

Ages Eligible for Study:  up to  55 Years,  Genders Eligible for Study:  Both

Criteria

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

• 55 and under

Performance status

• ECOG 0-2 OR
• Lansky 80-100%

Life expectancy

• At least 3 months

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

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Ohio
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-5065,  United States; Recruiting

Study chairs or principal investigators

Michael L. Nieder, MD,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000270380; CWRU-1Y00; NCT00054327
Record last reviewed:  January 2003
Last Updated:  December 6, 2004
Record first received:  February 5, 2003
ClinicalTrials.gov Identifier:  NCT00054327
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08