Clinical Trial: Combination Chemotherapy Plus Alemtuzumab Followed by Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

This study is currently recruiting patients.

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
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. Monoclonal antibodies such as alemtuzumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining chemotherapy and monoclonal antibody therapy may kill more cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus alemtuzumab followed by peripheral stem cell transplantation in treating patients who have hematologic cancer.

Condition Treatment or Intervention Phase
childhood Hodgkin's lymphoma
childhood non-Hodgkin's lymphoma
Leukemia
Lymphoma
myelodysplastic and myeloproliferative diseases
plasma cell neoplasm
 Drug: alemtuzumab
 Drug: cyclosporine
 Drug: fludarabine
 Drug: melphalan
 Procedure: allogeneic bone marrow transplantation
 Procedure: antibody therapy
 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: monoclonal antibody therapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: supportive care/therapy
Phase II

MedlinePlus related topics:  Blood and Blood Disorders;   Cancer;   Cancer Alternative Therapy;   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 a Nonmyeloablative Regimen Comprising Melphalan, Fludarabine, and Alemtuzumab Followed By Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Lymphohematopoietic Malignancies

Further Study Details: 

OBJECTIVES:

OUTLINE: Patients are stratified according to donor type (HLA-matched related vs HLA-matched unrelated, single HLA-allele disparate related, or unmatched).

Patients receive a nonmyeloablative regimen comprising alemtuzumab IV over 8 hours on days -8 to -5, fludarabine IV over 30 minutes on days -8 to -4, and melphalan IV over 30 minutes on days -3 and -2. Allogeneic peripheral blood stem cells or bone marrow is infused on day 0.

Patients receive graft-versus host disease prophylaxis comprising cyclosporine IV every 12 hours beginning on day -1 and continuing orally as tolerated until day 100.

Patients are followed every 6 weeks for 6 months, every 3 months for 6 months, every 3-6 months for 1 year, and then annually thereafter or as clinically indicated.

PROJECTED ACCRUAL: A maximum of 50 patients (25 HLA-matched related and 25 HLA-mismatched related or matched unrelated) will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:  up to  70 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of one of the following:
  • Relapsed or primary refractory non-Hodgkin's lymphoma (NHL)
  • Aggressive NHL histologies allowed if the following criteria are met:
  • Chemosensitive/radiosensitive, nonprogressive, or stable on therapy
  • Ineligible for autologous hematopoietic stem cell transplantation because of disease in bone marrow
  • Chemosensitive relapsed or refractory acute lymphoblastic leukemia or chronic lymphocytic leukemia
  • Relapsed or primary refractory Hodgkin's lymphoma
  • Stage II or III multiple myeloma
  • Advanced or refractory Waldenstrom's macroglobulinemia
  • Ineligible for protocols involving myeloablative conditioning regimens by virtue of any of the following conditions:
  • Advanced age
  • Intensity of prior radiotherapy and/or chemotherapy
  • History of prior toxicity associated with chemotherapy/radiotherapy
  • Existing organ damage
  • Diagnosis of chronic myeloid leukemia, high-risk acute myelogenous leukemia, or myelodysplastic syndromes allowed if no alternative, active, higher priority allogeneic transplantation protocol exists
  • Availability of an HLA-matched or a single HLA allele disparate related or unrelated donor
  • No uncontrolled CNS disease

PATIENT CHARACTERISTICS: Age:

  • 70 and under

Performance status:

  • Karnofsky 40-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 2.5 mg/dL
  • AST and ALT no greater than 3 times normal unless due to liver involvement with disease

Renal:

  • Creatinine no greater than 2.0 mg/dL OR
  • Creatinine clearance at least 30 mL/min

Cardiovascular:

  • Resting LVEF at least 30% by echocardiogram or MUGA scan

Pulmonary:

  • DLCO at least 40% of predicted
  • No requirement for supplementary oxygen

Other:

  • HIV negative
  • HTLV negative
  • No active or uncontrolled bacterial, viral, or fungal infection that would preclude myelosuppressive chemotherapy
  • Not pregnant or nursing
  • Negative pregnancy test

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • See Disease Characteristics

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy

  • Not specified

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • Not specified

Other:


Location and Contact Information


New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States; Recruiting
Farid Boulad, MD  212-639-6684    bouladf@mskcc.org 

Study chairs or principal investigators

Hugo R. Castro-Malaspina, MD,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

More Information

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

Study ID Numbers:  CDR0000069043; MSKCC-01092; NCI-G01-2028; NCT00027560
Record last reviewed:  October 2002
Last Updated:  December 6, 2004
Record first received:  December 7, 2001
ClinicalTrials.gov Identifier:  NCT00027560
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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