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Oral Combination Chemotherapy in Conjunction With G-CSF in the Treatment of Elderly Patients With Intermediate and High Grade Non-Hodgkin's Lymphoma


Phase 2
60 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Oral Combination Chemotherapy in Conjunction With G-CSF in the Treatment of Elderly Patients With Intermediate and High Grade Non-Hodgkin's Lymphoma


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.

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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

study the effectiveness of oral combination chemotherapy and G-CSF in elderly patients with intermediate- or high-grade non-Hodgkin's lymphomas.

Outcome Time Frame:

Patients receive one cycle of oral chemotherapy, 6 weeks in duration. Patients with a CR or PR response after 1 cycle of therapy receive 2 additional cycles of chemotherapy.

Safety Issue:

No

Principal Investigator

Scot C. Remick, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Federal Government

Study ID:

CWRU4496

NCT ID:

NCT00003113

Start Date:

July 1997

Completion Date:

December 2002

Related Keywords:

  • Lymphoma
  • stage I grade 3 follicular lymphoma
  • stage I adult diffuse small cleaved cell lymphoma
  • stage I adult diffuse mixed cell lymphoma
  • stage I adult diffuse large cell lymphoma
  • stage I adult immunoblastic large cell lymphoma
  • stage I adult lymphoblastic lymphoma
  • stage I adult Burkitt lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt lymphoma
  • stage I mantle cell lymphoma
  • contiguous stage II grade 3 follicular lymphoma
  • contiguous stage II adult diffuse small cleaved cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • contiguous stage II adult diffuse mixed cell lymphoma
  • contiguous stage II adult immunoblastic large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • contiguous stage II adult Burkitt lymphoma
  • contiguous stage II adult lymphoblastic lymphoma
  • noncontiguous stage II grade 3 follicular lymphoma
  • noncontiguous stage II adult diffuse small cleaved cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • noncontiguous stage II adult diffuse mixed cell lymphoma
  • noncontiguous stage II adult immunoblastic large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • noncontiguous stage II adult Burkitt lymphoma
  • noncontiguous stage II adult lymphoblastic lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • stage II mantle cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065