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| Sponsor: | Cancer and Leukemia Group B |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020943 |
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: filgrastim Biological: rituximab Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: leucovorin calcium Drug: methotrexate Drug: prednisone Drug: vincristine sulfate Procedure: bone marrow ablation with stem cell support Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Study Of Intensive Induction Chemotherapy Followed By Autologous Stem Cell Transplantation Plus Immunotherapy For Mantle Cell Lymphoma |
| Study Start Date: | June 2001 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
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 to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Presenting with at least one of the following:
Stage I-IV disease
No active CNS disease
Bidimensionally measurable disease greater than 1 cm
Nonmeasurable disease includes the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Hepatitis B surface antigen and hepatitis C antibody positive patients must meet all of the following criteria:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Northeast Alabama Regional Medical Center | |
| Anniston, Alabama, United States, 36207 | |
| Veterans Affairs Medical Center - Birmingham | |
| Birmingham, Alabama, United States, 35233-1996 | |
| United States, California | |
| Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center | |
| Los Angeles, California, United States, 90048 | |
| Hematology/Oncology Faculty Practice | |
| San Francisco, California, United States, 94143-0324 | |
| Naval Medical Center - San Diego | |
| San Diego, California, United States, 92134-3202 | |
| Rebecca and John Moores UCSD Cancer Center | |
| La Jolla, California, United States, 92093-0658 | |
| UCSF Comprehensive Cancer Center | |
| San Francisco, California, United States, 94115 | |
| Veterans Affairs Medical Center - San Diego | |
| San Diego, California, United States, 92161 | |
| Veterans Affairs Medical Center - San Francisco | |
| San Francisco, California, United States, 94121 | |
| United States, Delaware | |
| CCOP - Christiana Care Health Services | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| Lombardi Cancer Center at Georgetown University Medical Center | |
| Washington, District of Columbia, United States, 20007 | |
| Veterans Affairs Medical Center - Washington, DC | |
| Washington, District of Columbia, United States, 20422 | |
| Walter Reed Army Medical Center | |
| Washington, District of Columbia, United States, 20307-5001 | |
| United States, Florida | |
| Broward General Medical Center | |
| Fort Lauderdale, Florida, United States, 33316 | |
| CCOP - Mount Sinai Medical Center | |
| Miami Beach, Florida, United States, 33140 | |
| Memorial Regional Cancer Center at Memorial Regional Hospital | |
| Hollywood, Florida, United States, 33021 | |
| Palm Beach Cancer Institute | |
| West Palm Beach, Florida, United States, 33401 | |
| United States, Illinois | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615-7828 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| Veterans Affairs Medical Center - Chicago (Westside Hospital) | |
| Chicago, Illinois, United States, 60612 | |
| West Suburban Center for Cancer Care | |
| River Forest, Illinois, United States, 60305 | |
| United States, Indiana | |
| CCOP - Northern Indiana CR Consortium | |
| South Bend, Indiana, United States, 46601 | |
| Fort Wayne Medical Oncology and Hematology, Incorporated | |
| Fort Wayne, Indiana, United States, 46885-5099 | |
| United States, Iowa | |
| Holden Comprehensive Cancer Center at University of Iowa | |
| Iowa City, Iowa, United States, 52242-1009 | |
| United States, Kentucky | |
| Baptist Hospital East - Louisville | |
| Louisville, Kentucky, United States, 40207 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| UMASS Memorial Cancer Center - University Campus | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph | |
| Saint Joseph, Michigan, United States, 49085 | |
| United States, Minnesota | |
| University of Minnesota Cancer Center | |
| Minneapolis, Minnesota, United States, 55455 | |
| Veterans Affairs Medical Center - Minneapolis | |
| Minneapolis, Minnesota, United States, 55417 | |
| United States, Missouri | |
| CCOP - Kansas City | |
| Kansas City, Missouri, United States, 64131 | |
| Ellis Fischel Cancer Center at University of Missouri - Columbia | |
| Columbia, Missouri, United States, 65203 | |
| Missouri Baptist Cancer Center | |
| Saint Louis, Missouri, United States, 63131 | |
| Siteman Cancer Center at Barnes-Jewish Hospital | |
| Saint Louis, Missouri, United States, 63110 | |
| Veterans Affairs Medical Center - Columbia (Truman Memorial) | |
| Columbia, Missouri, United States, 65201 | |
| United States, Nebraska | |
| UNMC Eppley Cancer Center at the University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198-7680 | |
| United States, Nevada | |
| CCOP - Southern Nevada Cancer Research Foundation | |
| Las Vegas, Nevada, United States, 89106 | |
| Veterans Affairs Medical Center - Las Vegas | |
| Las Vegas, Nevada, United States, 89106 | |
| United States, New Hampshire | |
| New Hampshire Oncology-Hematology, PA - Hooksett | |
| Hooksett, New Hampshire, United States, 03106 | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| United States, New Jersey | |
| Cooper University Hospital | |
| Camden, New Jersey, United States, 08103 | |
| United States, New York | |
| CCOP - North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | |
| East Syracuse, New York, United States, 13057 | |
| Elmhurst Hospital Center | |
| Elmhurst, New York, United States, 11373 | |
| Queens Cancer Center of Queens Hospital | |
| Jamaica, New York, United States, 11432 | |
| Mount Sinai Medical Center | |
| New York, New York, United States, 10029 | |
| New York Weill Cornell Cancer Center at Cornell University | |
| New York, New York, United States, 10021 | |
| North Shore University Hospital | |
| Manhasset, New York, United States, 11030 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| University Hospital at State University of New York - Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Veterans Affairs Medical Center - Buffalo | |
| Buffalo, New York, United States, 14215 | |
| Veterans Affairs Medical Center - Syracuse | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Cape Fear Valley Health System | |
| Fayetteville, North Carolina, United States, 28302-2000 | |
| Lenoir Memorial Hospital Cancer Center | |
| Kinston, North Carolina, United States, 28503-1678 | |
| Comprehensive Cancer Center at Wake Forest University | |
| Winston-Salem, North Carolina, United States, 27157-1082 | |
| Duke Comprehensive Cancer Center | |
| Durham, North Carolina, United States, 27710 | |
| FirstHealth Moore Regional Hospital | |
| Pinehurst, North Carolina, United States, 28374 | |
| CCOP - Southeast Cancer Control Consortium | |
| Goldsboro, North Carolina, United States, 27534-9479 | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| NorthEast Oncology Associates - Concord | |
| Concord, North Carolina, United States, 28025 | |
| Veterans Affairs Medical Center - Asheville | |
| Asheville, North Carolina, United States, 28805 | |
| Veterans Affairs Medical Center - Durham | |
| Durham, North Carolina, United States, 27705 | |
| Zimmer Cancer Center at New Hanover Regional Medical Center | |
| Wilmington, North Carolina, United States, 28402-9025 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital at Ohio State University | |
| Columbus, Ohio, United States, 43210-1240 | |
| United States, Oklahoma | |
| Oklahoma University Medical Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| United States, Pennsylvania | |
| Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Rhode Island | |
| Lifespan: The Miriam Hospital | |
| Providence, Rhode Island, United States, 02906 | |
| United States, Tennessee | |
| University of Tennessee Cancer Institute | |
| Memphis, Tennessee, United States, 38104 | |
| Veterans Affairs Medical Center - Memphis | |
| Memphis, Tennessee, United States, 38104 | |
| United States, Texas | |
| Veterans Affairs Medical Center - Dallas | |
| Dallas, Texas, United States, 75219 | |
| United States, Vermont | |
| Green Mountain Oncology Group | |
| Bennington, Vermont, United States, 05201 | |
| Vermont Cancer Center at University of Vermont | |
| Burlington, Vermont, United States, 05401-3498 | |
| United States, Virginia | |
| Martha Jefferson Hospital | |
| Charlottesville, Virginia, United States, 22902 | |
| MBCCOP - Massey Cancer Center | |
| Richmond, Virginia, United States, 23298-0037 | |
| Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke | |
| Roanoke, Virginia, United States, 24014 | |
| Virginia Oncology Associates - Norfolk | |
| Norfolk, Virginia, United States, 23502 | |
| United States, West Virginia | |
| St. Mary's Medical Center | |
| Huntington, West Virginia, United States, 25701 | |
| Puerto Rico | |
| Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus | |
| San Juan, Puerto Rico, 00936-5067 | |
| Study Chair: | Lloyd Damon, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
More Information
| Study ID Numbers: | CDR0000068732, CALGB-59909 |
| Study First Received: | July 11, 2001 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00020943 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
|
Anti-Inflammatory Agents Prednisone Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Lymphoma, Mantle-Cell Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Therapeutic Uses Abortifacient Agents Methotrexate Etoposide Dermatologic Agents Nucleic Acid Synthesis Inhibitors |
Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Rituximab Carmustine Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin Neoplasms Lymphoma, Non-Hodgkin Antineoplastic Agents, Phytogenic Antimetabolites Immunologic Factors Antineoplastic Agents |
