Clinical trial NCT00003113: Oral Combination Chemotherapy in Treating Elderly Patients With Intermediate or High-Grade Non-Hodgkin's Lymphomas
Official title: Oral Combination Chemotherapy in Conjunction With G-CSF in the Treatment of Elderly Patients With Intermediate and High Grade Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lymphoma
Keywords: 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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-09-24
Enrollment: 6
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: study the effectiveness of oral combination chemotherapy and G-CSF in elderly patients with intermediate- or high-grade non-Hodgkin's lymphomas.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
name: Scot C. Remick, MD
role: PRINCIPAL_INVESTIGATOR
References: