RATIONALE: Peripheral stem cell transplantation or bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by donor bone marrow transplantation or peripheral stem cell transplantation in treating patients who have hematologic cancer or genetic disorders.

Condition	Treatment or Intervention	Phase
childhood Hodgkin's lymphoma childhood non-Hodgkin's lymphoma Leukemia Lymphoma plasma cell neoplasm	Drug: anti-thymocyte globulin  Drug: cyclosporine  Drug: fludarabine  Drug: melphalan  Drug: methylprednisolone  Drug: mycophenolate mofetil  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: graft versus host disease prophylaxis/therapy  Procedure: peripheral blood stem cell transplantation  Procedure: supportive care/therapy  Procedure: syngeneic bone marrow transplantation	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the hematopoietic recovery in patients with hematologic malignancies or genetic disorders treated with fludarabine and melphalan followed by allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation.
• Determine the chemotherapeutic toxicity of this regimen in these patients.
• Determine the relapse and survival of patients treated with this regimen.
• Determine the incidence of graft-versus-host disease in patients treated with this regimen.

OUTLINE: Patients receive fludarabine IV on days -6 to -2 and melphalan IV on days -3 and -2. Patients with a non-HLA-identical family member may also receive anti-thymocyte globulin on days -4 to -1. Patients undergo allogeneic or syngeneic bone marrow or peripheral blood stem cell transplantation on day 0. Patients receive graft-vs-host disease prophylaxis comprising mycophenolate mofetil twice daily beginning on day -3, methylprednisolone beginning on day 5 and continuing over 8 weeks, and cyclosporine IV or orally beginning on day -3 and continuing until at least 6 months post-transplantation.

Patients are followed at 1, 3, and 6 months, and then at 1 year post-transplantation.

PROJECTED ACCRUAL: A total of 52 patients will be accrued for this study within 5-6 years.

Ages Eligible for Study:  1 Year   -   80 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Clinically and/or histologically confirmed hematologic malignancy or genetic disorder
• Chronic myelogenous leukemia
• Typical blood and marrow morphology
• Presence of Philadelphia chromosome OR
• Molecular evidence of bcr/abl rearrangement if Philadelphia chromosome-negative
• Acute myeloid leukemia, acute lymphocytic leukemia, myelodysplasia, or lymphoma
• High risk of relapse or progressive disease
• Typical clinical features and morphology in blood, marrow, lymph node, or other tissue by cytochemistry, immunophenotyping, and/or chromosomal abnormalities
• Multiple myeloma
• Typical marrow morphology, radiographic findings, and paraprotein
• Aplastic anemia
• Typical marrow and blood findings
• Genetic disorder including storage disease (e.g., adrenoleukodystrophy), hemoglobinopathies (e.g., thalassemia), or severe immunodeficiency
• Unwilling to undergo conventional high-dose chemoradiotherapeutic conditioning prior to allogeneic stem cell transplantation OR
• Presence of other medical disorder which precludes high-dose chemoradiotherapeutic conditioning (e.g., cardiac disease or infection)
• Syngeneic twin, HLA-identical, or 1 or 2 HLA antigen-mismatched family member or unrelated donor

PATIENT CHARACTERISTICS: Age:

• 1 to 80

Performance status:

• Karnofsky 50-100%

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other serious medical or psychiatric illness that would preclude study compliance
• Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

Surgery:

• Not specified

New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting

Study chairs or principal investigators

David G. Savage, MD,  Study Chair,  Herbert Irving Comprehensive Cancer Center   

Study ID Numbers:  CDR0000068396; CPMC-IRB-8462; CPMC-IRB-CAMP-25; NCI-G00-1897; NCT00008307
Record last reviewed:  April 2001
Last Updated:  February 4, 2005
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00008307
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08