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Spots Global Cancer Trial Database for Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

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Trial Identification

Brief Title: Chemotherapy and Rituximab With Peripheral Stem Cell Transplantation in Treating Patients With Mantle Cell Lymphoma

Official Title: A Phase II Study Of Intensive Induction Chemotherapy Followed By Autologous Stem Cell Transplantation Plus Immunotherapy For Mantle Cell Lymphoma

Study ID: NCT00020943

Conditions

Lymphoma

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: * Determine the two-year progression-free survival of patients with mantle cell lymphoma treated with intensive chemotherapy and rituximab with autologous peripheral blood stem cell (PBSC) transplantation. * Determine the complete and partial response rates of patients treated with this regimen. * Determine the disease-free and overall survival of patients treated with this regimen. * Determine the autologous immune reconstitution in patients treated with this regimen. * Determine the feasibility of this regimen in this patient population. * Determine whether treatment with rituximab during autologous PBSC transplantation reduces the amount of contaminating lymphoma in the autologous PBSC product. 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

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

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

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

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

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

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

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

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

Hematology/Oncology Faculty Practice, San Francisco, California, United States

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

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

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

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

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

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

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

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

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

University of Chicago Cancer Research Center, Chicago, Illinois, United States

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

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

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

Fort Wayne Medical Oncology and Hematology, Incorporated, Fort Wayne, Indiana, United States

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Cooper University Hospital, Camden, New Jersey, United States

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

Roswell Park Cancer Institute, Buffalo, New York, United States

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

Elmhurst Hospital Center, Elmhurst, New York, United States

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

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

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

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

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

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

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

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

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

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

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

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

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

Cape Fear Valley Health System, Fayetteville, North Carolina, United States

CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, United States

Lenoir Memorial Hospital Cancer Center, Kinston, North Carolina, United States

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

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

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

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

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

Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States

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

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

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

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

Green Mountain Oncology Group, Bennington, Vermont, United States

Vermont Cancer Center at University of Vermont, Burlington, Vermont, United States

Martha Jefferson Hospital, Charlottesville, Virginia, United States

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

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

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

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

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

Contact Details

Name: Lloyd Damon, MD

Affiliation: University of California, San Francisco

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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