Clinical Trial: Chemotherapy and Rituximab With 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 tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy and rituximab with peripheral stem cell transplantation in treating patients who have mantle cell lymphoma.

Condition Treatment or Intervention Phase
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
 Drug: carmustine
 Drug: cyclophosphamide
 Drug: cytarabine
 Drug: doxorubicin
 Drug: etoposide
 Drug: filgrastim
 Drug: leucovorin calcium
 Drug: methotrexate
 Drug: prednisone
 Drug: rituximab
 Drug: vincristine
 Procedure: antibody therapy
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: chemotherapy
 Procedure: colony-stimulating factor therapy
 Procedure: cytokine therapy
 Procedure: high-dose chemotherapy
 Procedure: monoclonal antibody therapy
 Procedure: peripheral blood stem cell transplantation
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Intensive Chemotherapy and Rituximab With Autologous Peripheral Blood Stem Cell Transplantation in Patients With Mantle Cell Lymphoma

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a multicenter study.

Patients receive induction therapy comprising rituximab IV over 4-6 hours on day 1; methotrexate IV over 4 hours on day 2; cyclophosphamide IV over 2 hours, doxorubicin IV, and vincristine IV on day 3; and oral prednisone on days 3-7. Patients also receive leucovorin calcium IV every 6 hours beginning on day 3 and continuing until blood levels of methotrexate are safe. Filgrastim (G-CSF) is administered subcutaneously (SC) beginning on day 4 and continuing until blood counts recover.

Induction therapy repeats every 21-28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Rituximab may be omitted during course 1 if circulating mantle cells are excessive. Patients may receive a third course if more than 15% persistent bone marrow involvement is documented.

Patients with stable or responding disease begin consolidation therapy 29 days after the start of the final course of induction therapy. Patients receive cytarabine IV over 2 hours twice daily and etoposide IV over 96 hours on days 1-4. Patients also receive rituximab IV over 4-6 hours on days 5 or 6 and 12 or 13 and G-CSF SC beginning on day 14 and continuing until leukapheresis is complete. Patients undergo leukapheresis beginning between days 22-25 and continuing until adequate CD34 cells are collected.

Beginning 4 weeks after recovery from consolidation therapy, patients receive high-dose therapy comprising carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on day -2. Patients undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive G-CSF SC beginning on day 6 and continuing until blood counts recover.

After blood counts recover and more than 35 days after autologous PBSC transplantation, patients receive rituximab IV over 4-6 hours weekly for 2 weeks.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for up to 10 years.

PROJECTED ACCRUAL: At least 45 patients will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:  18 Years   -   69 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed mantle cell lymphoma
  • Presenting with at least one of the following:
  • Coexpression of CD20 (or CD19) and CD5 and a lack of CD23 expression by immunophenotyping
  • Positive for cyclin D1 by immunostaining
  • Presence of t(11,14) by cytogenetic analysis
  • Molecular evidence of bcl-1/IgH rearrangement
  • Stage I-IV disease
  • Stage III or IV if nodular histology mantle cell lymphoma present
  • Any stage for other mantle cell histologies
  • No mantle zone histology
  • No active CNS disease
  • No symptomatic meningeal lymphoma
  • No known CNS parenchymal lymphoma
  • Lumbar puncture showing mantle cell lymphoma allowed
  • Bidimensionally measurable disease greater than 1 cm
  • Nonmeasurable disease includes the following:
  • Bone lesions
  • Leptomeningeal disease
  • Ascites
  • Pleural/pericardial effusion
  • Inflammatory breast disease
  • Lymphangitis cutis/pulmonis
  • Abdominal masses not confirmed and followed by imaging techniques
  • Cystic lesions
  • Lesions in a previously irradiated area

PATIENT CHARACTERISTICS: Age:

  • 18 to 69

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Hepatitis B surface antigen and hepatitis C antibody positive patients must meet all of the following criteria:
  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST no greater than 3 times ULN
  • Liver biopsy shows no greater than grade 2 fibrosis and no cirrhosis

Renal:

  • Creatinine no greater than 2.0 mg/dL

Cardiovascular:

  • LVEF at least 45% by MUGA or echocardiogram

Other:

  • No known hypersensitivity to murine products
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy:

  • No more than 1 prior dose of rituximab

Chemotherapy:

  • No more than 1 prior cycle of chemotherapy
  • At least 3 weeks since prior chemotherapy
  • No other concurrent chemotherapeutic agents

Endocrine therapy:

  • No chronic use of oral corticosteroids for ongoing medical condition
  • No concurrent hormonal therapy except for non-lymphoma-related conditions (e.g., insulin for diabetes)
  • Other concurrent corticosteroids for adrenal failure, diffuse alveolar hemorrhage, carmustine pneumonitis, or as an anti-emetic allowed

Radiotherapy:

Surgery:

  • At least 2 weeks since prior major surgery

Location Information


Alabama
      Northeast Alabama Regional Medical Center, Anniston,  Alabama,  36207,  United States

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

California
      Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States

      Hematology/Oncology Faculty Practice, San Francisco,  California,  94143-0324,  United States

      Naval Medical Center - San Diego, San Diego,  California,  92134-3202,  United States

      Rebecca and John Moores UCSD Cancer Center, La Jolla,  California,  92093-0658,  United States

      UCSF Comprehensive Cancer Center, San Francisco,  California,  94115,  United States

      Veterans Affairs Medical Center - San Diego, San Diego,  California,  92161,  United States

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

Delaware
      CCOP - Christiana Care Health Services, Newark,  Delaware,  19713,  United States

District of Columbia
      Lombardi Cancer Center at Georgetown University Medical Center, Washington,  District of Columbia,  20007,  United States

      Veterans Affairs Medical Center - Washington, DC, Washington,  District of Columbia,  20422,  United States

      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5001,  United States

Florida
      Broward General Medical Center, Fort Lauderdale,  Florida,  33316,  United States

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

      Memorial Regional Cancer Center at Memorial Regional Hospital, Hollywood,  Florida,  33021,  United States

      Palm Beach Cancer Institute, West Palm Beach,  Florida,  33401,  United States

Illinois
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61615-7828,  United States

      Louis A. Weiss Memorial Hospital, Chicago,  Illinois,  60640,  United States

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

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

      West Suburban Center for Cancer Care, River Forest,  Illinois,  60305,  United States

Indiana
      CCOP - Northern Indiana CR Consortium, South Bend,  Indiana,  46601,  United States

      Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne,  Indiana,  46885-5099,  United States

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

Kentucky
      Baptist Hospital East - Louisville, Louisville,  Kentucky,  40207,  United States

Maryland
      Greenebaum Cancer Center at University of Maryland Medical Center, Baltimore,  Maryland,  21201,  United States

Massachusetts
      Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

      UMASS Memorial Cancer Center - University Campus, Worcester,  Massachusetts,  01655,  United States

Michigan
      Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph, Saint Joseph,  Michigan,  49085,  United States

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

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

Missouri
      CCOP - Kansas City, Kansas City,  Missouri,  64131,  United States

      Ellis Fischel Cancer Center at University of Missouri - Columbia, Columbia,  Missouri,  65203,  United States

      Missouri Baptist Cancer Center, Saint Louis,  Missouri,  63131,  United States

      Siteman Cancer Center at Barnes-Jewish Hospital, Saint Louis,  Missouri,  63110,  United States

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

Nebraska
      UNMC Eppley Cancer Center at the University of Nebraska Medical Center, Omaha,  Nebraska,  68198-7680,  United States

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

      Veterans Affairs Medical Center - Las Vegas, Las Vegas,  Nevada,  89106,  United States

New Hampshire
      New Hampshire Oncology-Hematology, PA - Hooksett, Hooksett,  New Hampshire,  03106,  United States

      Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon,  New Hampshire,  03756-0002,  United States

New Jersey
      Cooper University Hospital, Camden,  New Jersey,  08103,  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., East Syracuse,  New York,  13057,  United States

      Elmhurst Hospital Center, Elmhurst,  New York,  11373,  United States

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

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

      New York Weill Cornell Cancer Center at Cornell University, New York,  New York,  10021,  United States

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

      Queens Cancer Center of Queens Hospital, Jamaica,  New York,  11432,  United States

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

      University Hospital at 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
      Cape Fear Valley Health System, Fayetteville,  North Carolina,  28302-2000,  United States

      CCOP - Southeast Cancer Control Consortium, Goldsboro,  North Carolina,  27534-9479,  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

      FirstHealth Moore Regional Hospital, Pinehurst,  North Carolina,  28374,  United States

      Lenoir Memorial Hospital Cancer Center, Kinston,  North Carolina,  28503-1678,  United States

      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States

      NorthEast Oncology Associates - Concord, Concord,  North Carolina,  28025,  United States

      Veterans Affairs Medical Center - Asheville, Asheville,  North Carolina,  28805,  United States

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

      Zimmer Cancer Center at New Hanover Regional Medical Center, Wilmington,  North Carolina,  28402-9025,  United States

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

Oklahoma
      Oklahoma University Medical Center, Oklahoma City,  Oklahoma,  73104,  United States

Pennsylvania
      Western Pennsylvania Hospital, Pittsburgh,  Pennsylvania,  15224,  United States

Rhode Island
      Lifespan: The Miriam Hospital, Providence,  Rhode Island,  02906,  United States

Tennessee
      University of Tennessee Cancer Institute, Memphis,  Tennessee,  38104,  United States

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

Texas
      Veterans Affairs Medical Center - Dallas, Dallas,  Texas,  75219,  United States

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

      Vermont Cancer Center at University of Vermont, Burlington,  Vermont,  05401-3498,  United States

Virginia
      Martha Jefferson Hospital, Charlottesville,  Virginia,  22902,  United States

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

      Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke, Roanoke,  Virginia,  24014,  United States

      Virginia Oncology Associates - Norfolk, Norfolk,  Virginia,  23502,  United States

West Virginia
      St. Mary's Medical Center, Huntington,  West Virginia,  25701,  United States

Puerto Rico
      Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus, San Juan,  00936-5067,  Puerto Rico

Study chairs or principal investigators

Lloyd Damon, MD,  Study Chair,  University of California, San Francisco   

More Information

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

Study ID Numbers:  CDR0000068732; CALGB-59909
Record last reviewed:  December 2004
Last Updated:  December 9, 2004
Record first received:  July 11, 2001
ClinicalTrials.gov Identifier:  NCT00020943
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


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

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