Clinical Trial: Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

This study is no longer recruiting patients.

Sponsors and Collaborators: Cancer and Leukemia Group B
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. Combining more than one drug may kill more cancer cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by donor peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.

Condition Treatment or Intervention Phase
Graft Versus Host Disease
stage I mantle cell lymphoma
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma
recurrent mantle cell lymphoma
 Drug: allogeneic lymphocytes
 Drug: carmustine
 Drug: cytarabine
 Drug: etoposide
 Drug: melphalan
 Drug: methotrexate
 Drug: sargramostim
 Drug: tacrolimus
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: graft versus host disease prophylaxis/therapy
 Procedure: leukocyte therapy
 Procedure: peripheral blood lymphocyte therapy
 Procedure: peripheral blood stem cell transplantation
 Procedure: supportive care/therapy
Phase II

MedlinePlus related topics:  Immune System and Disorders;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Etoposide, Carmustine, Melphalan, and Cytarabine Followed By Allogeneic Peripheral Blood Stem Cell Transplantation in Patients With Mantle Cell Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a multicenter study.

Patients receive carmustine IV over 2 hours on day -6; etoposide IV over 3 hours and cytarabine IV over 1 hour every 12 hours on days -5 to -2 for a total of 8 doses; and melphalan IV over 20-30 minutes on day -1. Patients undergo allogeneic peripheral blood stem cell (PBSC) transplantation on day 0. Patients also receive tacrolimus IV continuously over 24 hours beginning on day -2 and then orally twice daily until day 120 and methotrexate IV over 30 minutes on days 1, 3, and 6 as graft-versus-host disease (GVHD) prophylaxis. Patients receive sargramostim (GM-CSF) IV or subcutaneously daily beginning on day 7 and continuing until blood counts recover.

Patients with no active GVHD who have persistent disease on day 150 or progressive disease at any time after PBSC transplantation receive donor lymphocytes IV over 2 hours. Patients may receive additional donor lymphocytes at least 8 weeks later if disease persists.

Patients are followed at 6 and 12 months posttransplantation and then annually for 4 years.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3.5 years.

Eligibility

Ages Eligible for Study:  up to  59 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed mantle cell lymphoma of any stage with at least 1 of the following:
  • Immunophenotype with expression of CD5 and CD19 and absence of CD23
  • Cytogenetic analysis with presence of t(11;14)
  • Overexpression of cyclin D1
  • Rearrangement of BCL1 gene
  • Bone marrow biopsy required
  • No needle or core biopsy as sole means of diagnosis
  • First remission allowed if at least 1 of the following poor prognostic characteristics present:
  • International Prognostic Index (IPI) score higher than 1 defined by the following risk factors:
  • Performance status higher than 1
  • Elevated LDH
  • Presence of more than 1 extranodal site
  • Stage III or IV disease
  • Blastic variant of mantle cell lymphoma*
  • Complex karyotypes (i.e., cytogenetic abnormalities different from or in addition to t(11;14)*
  • Proliferative index more than 10%*
  • Presence of p53 mutations NOTE: *Regardless of IPI score
  • Failure of initial therapy with anthracycline-containing regimen allowed
  • Failure to achieve clinical complete remission after initial therapy OR
  • Recurrent disease after initial therapy
  • HLA matched (6/6) sibling donor by serologic typing (A, B, or DR)
  • Any age
  • No syngeneic (identical twin) donor
  • No active CNS lymphoma

PATIENT CHARACTERISTICS: Age:

  • Under 60

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin less than 2 mg/dL
  • AST and ALT no greater than 3 times upper limit of normal

Renal:

  • Creatinine less than 2 mg/dL

Pulmonary:

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • HIV negative

PRIOR CONCURRENT THERAPY: Biologic therapy:

Chemotherapy:

  • See Disease Characteristics
  • No more than 2 prior chemotherapy regimens
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy

Radiotherapy:

Surgery:

  • See Disease Characteristics

Location Information


Alabama
      Veterans Affairs Medical Center - Birmingham, Birmingham,  Alabama,  35233-1996,  United States

California
      UCSF Cancer Center and Cancer Research Institute, San Francisco,  California,  94143-0128,  United States

      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States

      Veterans Affairs Medical Center - San Francisco, San Francisco,  California,  94121,  United States

Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States

District of Columbia
      Lombardi Cancer Center, Washington,  District of Columbia,  20007,  United States

      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States

Florida
      CCOP - Mount Sinai Medical Center, Miami Beach,  Florida,  33140,  United States

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States

      University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States

      Veterans Affairs Medical Center - Chicago (Westside Hospital), Chicago,  Illinois,  60612,  United States

Iowa
      Holden Comprehensive Cancer Center, Iowa City,  Iowa,  52242-1009,  United States

Maine
      Veterans Affairs Medical Center - Togus, Togus,  Maine,  04330,  United States

Maryland
      Marlene and Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States

Massachusetts
      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

      University of Massachusetts Memorial Medical Center - University Campus, Worcester,  Massachusetts,  01655,  United States

Minnesota
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States

      Veterans Affairs Medical Center - Minneapolis, Minneapolis,  Minnesota,  55417,  United States

Missouri
      Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States

      Ellis Fischel Cancer Center - Columbia, Columbia,  Missouri,  65203,  United States

      Veterans Affairs Medical Center - Columbia (Truman Memorial), Columbia,  Missouri,  65201,  United States

Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States

Nevada
      CCOP - Southern Nevada Cancer Research Foundation, Las Vegas,  Nevada,  89106,  United States

New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756-0002,  United States

New York
      CCOP - North Shore University Hospital, Manhasset,  New York,  11030,  United States

      CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C., Syracuse,  New York,  13217,  United States

      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

      Mount Sinai Medical Center, NY, New York,  New York,  10029,  United States

      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021,  United States

      North Shore University Hospital, Manhasset,  New York,  11030,  United States

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States

      Veterans Affairs Medical Center - Buffalo, Buffalo,  New York,  14215,  United States

      Veterans Affairs Medical Center - Syracuse, Syracuse,  New York,  13210,  United States

North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States

      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

      Lineberger Comprehensive Cancer Center, UNC, Chapel Hill,  North Carolina,  27599-7295,  United States

      Veterans Affairs Medical Center - Durham, Durham,  North Carolina,  27705,  United States

Ohio
      Arthur G. James Cancer Hospital - Ohio State University, Columbus,  Ohio,  43210-1240,  United States

Rhode Island
      Rhode Island Hospital, Providence,  Rhode Island,  02903,  United States

Tennessee
      University of Tennessee Cancer Institute, Memphis,  Tennessee,  38103,  United States

      Veterans Affairs Medical Center - Memphis, Memphis,  Tennessee,  38104,  United States

Vermont
      Green Mountain Oncology Group, Bennington,  Vermont,  05201,  United States

      Vermont Cancer Center, Burlington,  Vermont,  05401-3498,  United States

      Veterans Affairs Medical Center - White River Junction, White River Junction,  Vermont,  05009,  United States

Virginia
      MBCCOP - Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States

      Veterans Affairs Medical Center - Richmond, Richmond,  Virginia,  23249,  United States

Study chairs or principal investigators

Koen Van Besien, MD,  Study Chair,  University of Illinois   

More Information

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

Study ID Numbers:  CDR0000068324; CLB-59908
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  December 6, 2000
ClinicalTrials.gov Identifier:  NCT00006747
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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