A Phase 2 interventional study of filgrastim and cyclophosphamide in Lymphoma, sponsored by Case Comprehensive Cancer Center. Completed at 4 sites in 3 countries. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2010-06-11.
Sponsored by Case Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining lomustine, etoposide, cyclophosphamide, and procarbazine in treating patients who have AIDS-related non-Hodgkin's lymphoma.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive oral lomustine on day 1 (course 1 only), oral etoposide on days 1-3, and oral cyclophosphamide and oral procarbazine on days 22-26. Patients may also receive filgrastim (G-CSF) subcutaneously on days 5-21 and 28-42. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on days 1 and 22 of each course, at day 84, and then every 3 months for 1 year.
Patients are followed at day 84 and then every 3 months.
PROJECTED ACCRUAL: A total of 66 patients (22 in the United States and 44 in Africa) will be accrued for this study within 3-4 years.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 54 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed stage I, II, III, or IV intermediate- or high-grade non-Hodgkin's lymphoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
filgrastim (G-CSF) subcutaneously on days 5-21 and 28-42. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Oral cyclophosphamide on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Oral etoposide on days 1-3. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Oral lomustine on day 1 (course 1 only). Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Oral procarbazine on days 22-26. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Disease response
Time frame: Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.
Quality of life as assessed by the Functional Living Index-Cancer and the Brief Symptom Inventory
Time frame: days 1 and 2 of courses 1 and 2 and on day 84
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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Case Comprehensive Cancer Center