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.

Condition	Treatment or Intervention	Phase
Lymphoma	Procedure: chemotherapy  Procedure: biological response modifier therapy  Procedure: radiation therapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy  Drug: cyclophosphamide  Drug: etoposide  Drug: filgrastim  Drug: lomustine  Drug: procarbazine	Phase II

Further Study 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.

Ages Eligible for Study:  60 Years and above

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

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

Study chairs or principal investigators

Scot C. Remick,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000065862; CWRU-4496; NCI-G97-1350; AMC-1C-93
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003113
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08