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Home > "5" Clinical Trials Conditions > 506U78 in Treating Patients With Lymphoma  506U78 in Treating Patients With Lymphoma
506U78 in Treating Patients With Lymphoma
For Condition: Leukemia,Lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Cancer and Leukemia Group B
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have lymphoma that has not been treated previously or that has not responded to previous treatment.
Details: OBJECTIVES: I. Determine the complete and partial remission rates and remission duration in patients with previously systemically untreated cutaneous T-cell lymphoma or refractory or relapsed noncutaneous peripheral T-cell lymphoma treated with 506U78. II. Determine the safety and toxicity of this treatment regimen in this patient population. PROTOCOL OUTLINE: Patients are stratified according to diagnosis (cutaneous T-cell lymphoma vs peripheral T-cell lymphoma). Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment repeats every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response receive up to a maximum of 8 courses of therapy. Patients are followed every 3 months for 1 year, and then every 6 months for 1 year or until relapse. PROJECTED ACCRUAL: A total of 34-74 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /69 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically and immunophenotypically confirmed cutaneous T-cell lymphoma (CTCL) or noncutaneous peripheral T-cell lymphoma (PTCL) including: Mycosis fungoides/Sezary syndrome; Medium, mixed medium-large, or large cell PTCL; PTCL variants: Angioimmunoblastic T-cell lymphoma; Angiocentric lymphoma; Intestinal T-cell lymphoma; Adult T-cell lymphoma/leukemia; Anaplastic large cell (CD30+) T-cell lymphoma - Measurable disease Must have measurable skin lesions for CTCL; No barium studies No ascites or pleural effusion; No bony disease; No bone marrow - No CNS lymphoma requiring intrathecal or craniospinal radiotherapy - May have failed no more than 2 prior treatment regimens (one may include peripheral blood stem cell transplantation) for PTCL --Prior/Concurrent Therapy-- - Biologic therapy: See Disease Characteristics; Prior local or topical interferon, monoclonal antibodies, or fusion toxins for CTCL allowed; Recovered from prior biologic therapy - Chemotherapy: See Disease Characteristics; No prior systemic chemotherapy for CTCL; Prior local or topical chemotherapy for CTCL allowed; Recovered from prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: See Disease Characteristics; No concurrent hormonal therapy except steroids for adrenal failure or hormones for nondisease related conditions (e.g., insulin for diabetes); No concurrent dexamethasone or other steroidal antiemetics - Radiotherapy: See Disease Characteristics; Prior local radiotherapy or electron beam therapy for CTCL allowed; Recovered from prior radiotherapy - Surgery: Not specified - Other: Prior local or topical retinoids for CTCL allowed --Patient Characteristics-- - Age: Under 70 - Performance status: 0-2 - Life expectancy: Not specified - Hematopoietic: Not specified - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal - Renal: Creatinine clearance at least 50 mL/min (unless due to lymphoma) - Other: HIV negative; No history of seizure disorder; Neurologic toxicity no greater than grade; 1 Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelSchuster, Study Chair, Cancer and Leukemia Group B
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
Syracuse, New York, 13217
United States
Veterans Affairs Medical Center - Richmond
Richmond, Virginia, 23249
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
CCOP - Christiana Care Health Services
Wilmington, Delaware, 19899
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
MBCCOP - Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
University of Illinois at Chicago Health Sciences Center
Chicago, Illinois, 60612
United States
Veterans Affairs Medical Center - Buffalo
Buffalo, New York, 14215
United States
Veterans Affairs Medical Center - Syracuse
Syracuse, New York, 13210
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Veterans Affairs Medical Center - Durham
Durham, North Carolina, 27705
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
CCOP - Southwestern Vermont Regional Cancer Center
Bennington, Vermont, 05201
United States
Lombardi Cancer Center, Georgetown University
Washington D.C., District of Columbia, 20007
United States
Veterans Affairs Medical Center - Togus
Togus, Maine, 04330
United States
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, 35233
United States
Veterans Affairs Medical Center - Memphis
Memphis, Tennessee, 38104
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
CCOP - Mount Sinai Medical Center
Miami, Florida, 33140
United States
Veterans Affairs Medical Center - Chicago (Westside Hospital)
Chicago, Illinois, 60612
United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, 05009
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Vermont Cancer Center
Burlington, Vermont, 05401-3498
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Veterans Affairs Medical Center - San Francisco
San Francisco, California, 94121
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Veterans Affairs Medical Center - Columbia (Truman Memorial)
Columbia, Missouri, 65201
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
North Shore University Hospital
Manhasset, New York, 11030
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
Additional Information:
Study ID Numbers: CDR0000067687; CLB-59901,CALGB-59901
Study Start Date: May 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005080
Other Leukemia Studies:
1. Safety and Efficacy of 90Y Zevalin in Nonmyeloablative Transplantation for Lymphoid Malignancies
2. Monoclonal Antibodies in Detecting Residual Disease in Patients Who Have Been Treated for Non-Hodgkin's Lymphoma
3. Bone Marrow Transplantation in Treating Patients With Leukemia, Myelodysplasia, or Lymphoblastic Lymphoma
4. Campath-1H and EPOCH to Treat non-Hodgkin's T- and NK-Cell Lymphomas
5. UCN-01 in Treating Patients With Advanced Cancer
Related Studies:
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506U78 in Treating Patients With Lymphoma
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