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Home > "M" Clinical Trials Conditions > Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
For Condition: stage 4 chronic lymphocytic leukemia,T-cell chronic lymphocytic leukemia,stage 3 chronic lymphocytic leukemia,stage 1 chronic lymphocytic leukemia,stage 2 chronic lymphocytic leukemia
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
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 methotrexate with or without cyclophosphamide in treating patients who have lymphocyticleukemia with neutropenia or anemia.
Details: OBJECTIVES: - Determine the complete, partial, and overall response rates to methotrexate in patients with large granular lymphocytic (LGL) leukemia presenting with neutropenia or anemia. - Determine the complete, partial, and overall response rates to cyclophosphamide in the patients who fail to respond to methotrexate. - Assess the association of clinical response with increased sensitivity of leukemic LGL to Fas-dependent apoptosis, reduction in levels of Fas ligand, and disappearance of leukemic clone. - Determine the toxic effects of methotrexate and cyclophosphamide in these patients. OUTLINE: Patients are stratified according to symptom (neutropenia vs anemia). Patients receive oral methotrexate once a week for 4 months and oral prednisone daily for 54 days. Patients who show a partial response to methotrexate may continue this therapy for up to 1 year. Patients who do not respond to this therapy after 4 months then receive oral cyclophosphamide daily for up to 1 year and oral prednisone daily for 54 days. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 38-88 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Cytologically proven T-cell large granular lymphocytic (LGL) leukemia - Absolute LGL count greater than 500/mm3 (peripheral blood only) - CD3+ and CD57+ cells greater than 400/mm3 OR - CD8+ cells greater than 650/mm3 - Clonal T-cell receptor gene rearrangement - At least 1 of the following: - Severe neutropenia (neutrophil count less than 500/mm3) - Neutropenia associated with recurrent infections - Symptomatic anemia - Transfusion dependent anemia PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - At least 2 years Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin no greater than 2.0 mg/dL - SGOT no greater than 1.5 times normal Renal: - Creatinine no greater than 2.0 mg/dL Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior or concurrent malignancy within past 5 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix - No other serious medical illness - No concurrent psychiatric condition PRIOR CONCURRENT THERAPY: - No prior oral methotrexate or cyclophosphamide
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ThomasLoughran, Study Chair, Milton S. Hershey Medical Center
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Cancer Answers 800-456-7121
CCOP - Illinois Oncology Research Association *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Beth Israel Deaconess Medical Center *Recruiting*
Boston, Massachusetts, 02215
United States
Recruiting Michael Atkins 617-667-1930
CCOP - Mayo Clinic Scottsdale Oncology Program *Recruiting*
Scottsdale, Arizona, 85259-5404
United States
Recruiting Tom Fitch 480-301-9875
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
Additional Information:
Study ID Numbers: CDR0000067089; ECOG-5998
Study Start Date:
Record last reviewed: September 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003910
Other Stage 2 Chronic Lymphocytic Leukemia Studies:
1. Fludarabine Followed by Campath-1H in Treating Patients With Chronic Lymphocytic Leukemia
2. Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
3. Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
4. Alemtuzumab Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
5. High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
Related Studies:
Other stage 2 chronic lymphocytic leukemia Clinical Trials
Other Illinois Clinical Trials
Other Urbana Clinical Trials
Methotrexate With or Without Cyclophosphamide in Treating Patients With Lymphocytic Leukemia
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