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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003829 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Alternating treatment with more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of fludarabine alternating with cyclophosphamide in treating patients who have previously untreated chronic lymphocytic leukemia.
Condition | Intervention | Phase |
Leukemia |
Drug: cyclophosphamide Drug: fludarabine phosphate |
Phase II |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
ChemIDplus related topics: | Cyclophosphamide Fludarabine Fludarabine monophosphate |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | `A Phase II Study of Alternating Cycles of Fludarabine and Cyclophosphamide in Previously Untreated Patients With B-Cell CLL |
Estimated Enrollment: | 30 |
Study Start Date: | August 1999 |
OBJECTIVES: I. Determine the rate and duration of complete and partial remissions in patients with previously untreated B-cell chronic lymphocytic leukemia after treatment with alternating courses of fludarabine and cyclophosphamide. II. Monitor and assess toxicity of this regimen in these patients. III. Utilize molecular genetic studies and flow cytometry on peripheral blood cells from patients achieving complete remission by conventional criteria. IV. Apply FISH techniques using probes to chromosomes 12 and 13 as prognostic factors for time to progression and overall survival of these patients.
OUTLINE: Patients receive alternating courses of fludarabine and cyclophosphamide. Fludarabine is administered IV over 10-30 minutes on days 1-5 of courses 1, 3, and 5. Cyclophosphamide is administered IV over 30-60 minutes on day 1 of courses 2, 4, and 6. Treatment repeats every 4 weeks. Patients achieving clinical complete remission (CCR) after 6 courses of chemotherapy receive 2 additional courses (one course of each drug). Patients achieving partial remission after 6 courses of chemotherapy also receive 2 additional courses. If these patients then achieve CCR, they receive another 2 courses. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 22 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Diagnosis of B-cell chronic lymphocytic leukemia (CLL) manifested by all of the following: Threshold peripheral lymphocyte count greater than 5000/mm3 Small to moderate peripheral lymphocytes with no greater than 55% prolymphocytes Peripheral lymphocyte count less than 15,000/mm3 At least 30% lymphoid cells in bone marrow Monoclonality of B lymphocytes Active disease by at least one of the following criteria: Weight loss of at least 10% within the past 6 months or prolonged fever or night sweats without evidence of infection Progressive marrow failure (stage III or IV disease) manifested by Hemoglobin less than 11 g/dL (anemia) AND/OR Platelet count less than 100,000/mm3 (thrombocytopenia) Autoimmune anemia and/or thrombocytopenia minimally responsive to corticosteroid therapy Massive or progressive splenomegaly Massive or progressive lymphadenopathy Progressive lymphocytosis (not due to the effects of corticosteroids) Marked hypogammaglobulinemia or development of monoclonal protein in the absence of any of the above criteria is not sufficient for eligibility
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN (unless due to hemolysis or CLL) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No New York Heart Association class III or IV heart disease No myocardial infarction in the past month Other: No uncontrolled infection No active infection with HIV (AIDS) No other malignancy within past 2 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: Prior interferon allowed Chemotherapy: No prior cytotoxic chemotherapy Endocrine therapy: See Disease Characteristics Prior corticosteroids, somatostatin analogues, and tamoxifen allowed Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior major surgery
United States, Arizona | |||||
CCOP - Scottsdale Oncology Program | |||||
Scottsdale, Arizona, United States, 85259-5404 | |||||
United States, Illinois | |||||
CCOP - Carle Cancer Center | |||||
Urbana, Illinois, United States, 61801 | |||||
CCOP - Illinois Oncology Research Association | |||||
Peoria, Illinois, United States, 61602 | |||||
United States, Iowa | |||||
CCOP - Cedar Rapids Oncology Project | |||||
Cedar Rapids, Iowa, United States, 52403-1206 | |||||
CCOP - Iowa Oncology Research Association | |||||
Des Moines, Iowa, United States, 50309-1016 | |||||
Siouxland Hematology-Oncology | |||||
Sioux City, Iowa, United States, 51101-1733 | |||||
United States, Kansas | |||||
CCOP - Wichita | |||||
Wichita, Kansas, United States, 67214-3882 | |||||
United States, Michigan | |||||
CCOP - Ann Arbor Regional | |||||
Ann Arbor, Michigan, United States, 48106 | |||||
United States, Minnesota | |||||
CCOP - Duluth | |||||
Duluth, Minnesota, United States, 55805 | |||||
CCOP - Metro-Minnesota | |||||
Saint Louis Park, Minnesota, United States, 55416 | |||||
CentraCare Clinic | |||||
Saint Cloud, Minnesota, United States, 56303 | |||||
Mayo Clinic Cancer Center | |||||
Rochester, Minnesota, United States, 55905 | |||||
United States, Nebraska | |||||
CCOP - Missouri Valley Cancer Consortium | |||||
Omaha, Nebraska, United States, 68131 | |||||
United States, North Dakota | |||||
Altru Health Systems | |||||
Grand Forks, North Dakota, United States, 58201 | |||||
Quain & Ramstad Clinic, P.C. | |||||
Bismarck, North Dakota, United States, 58501 | |||||
United States, South Dakota | |||||
CCOP - Sioux Community Cancer Consortium | |||||
Sioux Falls, South Dakota, United States, 57105-1080 | |||||
Rapid City Regional Hospital | |||||
Rapid City, South Dakota, United States, 57709 |
North Central Cancer Treatment Group |
National Cancer Institute (NCI) |
Study Chair: | Thomas E. Witzig, MD | Mayo Clinic |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000066985, NCCTG-978151 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003829 |
Health Authority: | United States: Federal Government |
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