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Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma Clinical research trials and Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma. Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma  Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma
Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma
For Condition: stage 4 grade II follicular mixed cell lymphoma,recurrent grade I follicular small cleaved cell lymphoma,recurrent grade II follicular mixed cell lymphoma,stage 4 grade I follicular small cleaved cell 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 cyclophosphamide and filgrastim in treating patients with stage IV, relapsed, or refractory low-grade follicular non-Hodgkin's lymphoma.
Details: OBJECTIVES: I. Determine the feasibility of high-dose cyclophosphamide and filgrastim (G-CSF) in patients with stage IV, relapsed, or progressive low-grade follicular non-Hodgkin's lymphoma. II. Determine the toxic effects of this regimen in these patients, including those with marrow involvement. III. Determine the rates of complete remission (CR) and partial remission and time to failure in previously treated and untreated patients. IV. Determine the effectiveness of this regimen in eradicating bcl-2 rearrangements, as determined by polymerase chain reaction (PCR), in previously untreated patients. V. Correlate the duration of CR to PCR results in responding patients. PROTOCOL OUTLINE: Patients are stratified according to prior treatment (yes vs no). Patients receive cyclophosphamide IV over 90 minutes on day 1 and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing until blood counts recover. Treatment continues every 2 weeks for 4 courses in the absence of disease progression or stable disease. Patients who achieve complete remission (CR) after completion of course 4 receive 2 additional courses. Patients who achieve partial remission (PR) after completion of course 4 receive 2 additional courses, and those who achieve CR after completion of course 6 receive 2 additional courses. Patients are followed every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/55 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven low-grade non-Hodgkin's lymphoma of the following subtypes: Follicular, predominantly small cleaved cell; Follicular mixed (small cleaved and large cell) - Previously treated on Protocol CLB 8691 or previously untreated - Previously untreated patients with Stage IV disease (Ann Arbor classification) must meet the following conditions: Documented bone marrow involvement; Lymph node biopsy must not show higher grade lymphoma; At least 1 additional risk factor as follows: At least 2 extranodal sites; Nodes or nodal group at least 5 cm; Male - Previously treated patients must have progressed or relapsed on Protocol CLB-8691; Recurrence should be documented by biopsy if possible - Bidimensionally measurable disease by physical exam, radiograph, CT, or MRI (sonography and barium studies alone not acceptable) Measurable liver disease defined as: Mass greater than 3.5 cm on CT, MRI, or ultrasound OR Histologically documented lymphomatous hepatomegaly more than 5 cm below the costal margin; The following disease manifestations are not considered measurable: Ascites or pleural effusion; Bony disease (lytic lesions on x-ray should be documented and followed); CNS lesions; Bone marrow involvement - No lymphomatous involvement (including CNS lymphoma) requiring immediate radiotherapy [A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.] --Prior/Concurrent Therapy-- - Biologic therapy: Prior interferon only on Protocol CLB-8691 allowed - Chemotherapy: Prior oral cyclophosphamide only on Protocol CLB-8691 allowed; No concurrent chemotherapy - Endocrine therapy: No chronic steroids for other health problems; No concurrent steroids for any condition including documented CNS metastases, adrenal failure, or septic shock; Nonsteroidal hormonal drugs for nondisease related problems allowed (e.g., insulin for diabetes) - Radiotherapy: See Disease Characteristics; No prior radiotherapy; No concurrent palliative radiotherapy - Surgery: At least 2 weeks since prior major surgery - Other: No other prior therapy --Patient Characteristics-- - Age: 18 to physiologic 55; Patients over 55 are eligible only if study chairperson agrees that the patient can tolerate intensive chemotherapy - Performance status: Zubrod 0-1 - Life expectancy: More than 2 years - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9.0 g/dL - Hepatic: Bilirubin less than 1.5 times normal - Renal: Creatinine less than 1.5 times normal - Cardiovascular: LVEF at least 50% No acute changes or arrhythmias on ECG; No cardiomegaly on chest x-ray or physical exam; No uncontrolled or severe cardiovascular disease, including myocardial infarction within the past 6 months or congestive heart failure (CHF); No active cardiac problems, including compensated CHF or angina - Other: HIV negative; No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix; No active uncontrolled bacterial, viral, or fungal infection No other serious medical illness that would limit survival to less than 2 years; No psychiatric condition that would preclude informed consent or compliance; No uncontrolled duodenal ulcer; Not pregnant; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertPerri, Study Chair, Cancer and Leukemia Group B
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
United States
CCOP - Southeast Cancer Control Consortium
Winston Salem, North Carolina, 27104-4241
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, 38103
United States
Barnes-Jewish Hospital
St. Louis, Missouri, 63110
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637
United States
Norris Cotton Cancer Center
Lebanon, New Hampshire, 03756
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, 27157-1082
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
CCOP - North Shore University Hospital
Manhasset, New York, 11030
United States
Additional Information:
Study ID Numbers: CDR0000077861; CLB-9150
Study Start Date: October 1992
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002501
Other Recurrent Grade I Follicular Small Cleaved Cell Lymphoma Studies:
1. Interferon Alfa Plus Thalidomide in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
2. Monoclonal Antibody Therapy in Treating Patients With Refractory or Recurrent Non-Hodgkin's Lymphoma
3. Interferon alfa-2b Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Hodgkin's Disease or Non- Hodgkin's Lymphoma
4. Etoposide in Treating Patients With Relapsed Non-Hodgkin's Lymphoma
5. Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent grade I follicular small cleaved cell lymphoma Clinical Trials
Other Tennessee Clinical Trials
Other Memphis Clinical Trials
Cyclophosphamide and Filgrastim in Treating Patients With Stage IV, Relapsed, or Refractory Low-Grade Follicular Non-Hodgkin's Lymphoma
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