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Oral Combination Chemotherapy in Treating Elderly Patients With Intermediate or High-Grade Non-Hodgkin's Lymphomas



Oral Combination Chemotherapy in Treating Elderly Patients With Intermediate or High-Grade Non-Hodgkin's Lymphomas

For Condition: Lymphoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Ireland Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of oral combination chemotherapy and G-CSF in elderly patients with intermediate- or high-grade non-Hodgkin's lymphomas.
Details: OBJECTIVES: I. Assess the feasibility and toxicity of oral combination chemotherapy with granulocyte colony-stimulating factor in elderly patients with intermediate and high grade non-Hodgkin's lymphoma. II. Determine the objective response rate, response duration, and survival in this patient population. PROTOCOL OUTLINE: All patients receive one cycle of oral chemotherapy, 6 weeks in duration. Etoposide is given on days 1-3 and cyclophosphamide and procarbazine are given on days 22-31 of each cycle. Lomustine is given on day 1 of cycles 1 and 3 only. Filgrastim (granulocyte colony-stimulating factor; G-CSF) is given subcutaneously on days 5-21 and 33-42 of each cycle. Patients who have disease progression after one cycle of therapy or at any time thereafter are taken off the study. Patients with a complete response after 1 cycle of therapy receive 2 additional cycles of chemotherapy and are observed off treatment. Patients with a partial response (PR) also receive 2 additional cycles of chemotherapy. Following the third cycle of chemotherapy, if residual disease is confined to 1 or 2 nodal sites, patients receive radiation therapy. All other patients with a PR are treated at investigator's discretion. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A maximum of 32 patients will be accrued for this study.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 60 Years/
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Biopsy proven stage I through IV intermediate to high grade non-Hodgkin's lymphoma of B-cell, T-cell, or indeterminate immunologic phenotype - Measurable or evaluable - No cytologic or radiographic evidence of CNS lymphoma --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: Not specified - Radiotherapy: Prior radiotherapy allowed for localized stage I or II disease that has progressed beyond initial radiotherapy ports - Surgery: Not specified --Patient Characteristics-- - Age: 60 and over - Performance status: ECOG 0-3 - Life expectancy: At least 6 weeks - Hematopoietic: WBC at least 1500/mm3; Platelet count at least 50,000/mm3 - Hepatic: Bilirubin no greater than 3.0 mg/dL - Renal: Creatinine no greater than 3.0 mg/dL
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
ScotRemick,  Study Chair,  Ireland Cancer Center

Ireland Cancer Center
Cleveland,  Ohio,  44106-5065
United States
 


Additional Information:
Study ID Numbers:
  CDR0000065862;  CWRU-4496,NCI-G97-1350,AMC-1C-93
Study Start Date: July 1997
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003113

Other Lymphoma Studies:
1. Interleukin-12 in Treating Patients With Hematologic Cancers or Solid Tumors

2. Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Other B-cell Cancers

3. Combination Chemotherapy in Treating Patients With Recurrent or Refractory Leukemia or Lymphoma

4. Total-Body Irradiation, Cyclophosphamide, and Stem Cell Transplantation in Treating Patients With Hematologic Cancer

5. Selective T-Cell Depletion to Reduce Graft-Versus-Host-Disease in Patients Receiving Stem Cell Transplantation to Treat Leukemia, Lymphoma or Myelodysplastic Syndromes

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Oral Combination Chemotherapy in Treating Elderly Patients With Intermediate or High-Grade Non-Hodgkin's Lymphomas

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