Clinical Trial: Combination Chemotherapy Followed by Donor Bone Marrow Transplantation or Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer or Genetic Disorders

This study is currently recruiting patients.

Sponsors and Collaborators: Herbert Irving Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Hodgkin's Disease;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma;   Multiple Myeloma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Fludarabine and Melphalan Followed By Allogeneic or Syngeneic Bone Marrow or Peripheral Blood Stem Cell Transplantation in Patients With Hematologic Malignancies or Genetic Disorders

Further Study Details: 

OBJECTIVES:

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.

Eligibility

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

Location and Contact Information


New York
      Herbert Irving Comprehensive Cancer Center at Columbia University, New York,  New York,  10032,  United States; Recruiting
David G. Savage, MD  212-305-9783 

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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