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

NCT ID: NCT00003113

Last Updated: 2011-01-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-07-31
• Study Completion Date: 2002-12-31

Brief Summary

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.

Detailed Description

OBJECTIVES:

• 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.
• Determine the objective response rate, response duration, and survival in this patient population.

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.

Conditions

Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

filgrastim

Filgrastim (granulocyte colony-stimulating factor; G-CSF) is given subcutaneously on days 5-21 and 33-42 of each cycle.

Intervention Type: BIOLOGICAL

cyclophosphamide

Cyclophosphamide are given on days 22-31 of each cycle.

Intervention Type: DRUG

etoposide

Etoposide is given on days 1-3.

Intervention Type: DRUG

lomustine

Lomustine is given on day 1 of cycles 1 and 3 only.

Intervention Type: DRUG

procarbazine hydrochloride

Procarbazine are given on days 22-31 of each cycle.

Intervention Type: DRUG

radiation therapy

Following the third cycle of chemotherapy, if residual disease is confined to 1 or 2 nodal sites, patients receive radiation therapy.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

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

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Principal Investigators

Scot C. Remick, MD

Role: PRINCIPAL_INVESTIGATOR

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Locations

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CWRU-4496

Identifier Type: OTHER

Identifier Source: secondary_id

AMC-1C-93

Identifier Type: -

Identifier Source: secondary_id

NCI-G97-1350

Identifier Type: -

Identifier Source: secondary_id

CWRU4496

Identifier Type: -

Identifier Source: org_study_id