Rituximab Plus Cyclophosphamide in Treating Patients With Indolent Stage III or Stage IV Non-Hodgkin's Lymphoma
| Status: | Withdrawn |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | May 1998 |
| End Date: | January 2000 |
Rituximab Anti-CD20 Monoclonal Antibody Plus Oral Cyclophosphamide as Initial Treatment of Indolent Lymphoma
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver
cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy
use different ways to stop cancer cells from dividing so they stop growing or die. Combining
chemotherapy and monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab plus cyclophosphamide in
treating patients who have indolent stage III or stage IV non-Hodgkin's lymphoma.
cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy
use different ways to stop cancer cells from dividing so they stop growing or die. Combining
chemotherapy and monoclonal antibody therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of rituximab plus cyclophosphamide in
treating patients who have indolent stage III or stage IV non-Hodgkin's lymphoma.
OBJECTIVES: I. Determine the toxicity associated with cyclophosphamide and rituximab
(IDEC-C2B8 monoclonal antibody) as first line treatment in patients with stage III or IV
indolent B-cell lymphoma. II. Determine the objective tumor response rate and duration of
response associated with this first line treatment in these patients. III. Determine the
failure-free and overall survival for these patients. IV. Compare the response rate and
survival rates for patients with indolent lymphoma who were treated with this treatment as
the first systemic therapy for their disease with response rates and survival observed for
similar patients treated in published trials. V. Determine the quality of life associated
with this treatment in this patient population.
OUTLINE: This is an open label study. Patients receive oral cyclophosphamide daily and
rituximab (IDEC-C2B8 monoclonal antibody) IV on days 1, 8, 15, and 22 for the first 4-week
course. Patients then receive oral cyclophosphamide daily and rituximab IV monthly until 2
months beyond maximum response. Patients are treated for at least 6 months but no more than
18 months in the absence of disease progression. Patients are followed every 3 months for 2
years, then every 6 months for the next 2 years, and then annually for up to 10 years.
PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.
(IDEC-C2B8 monoclonal antibody) as first line treatment in patients with stage III or IV
indolent B-cell lymphoma. II. Determine the objective tumor response rate and duration of
response associated with this first line treatment in these patients. III. Determine the
failure-free and overall survival for these patients. IV. Compare the response rate and
survival rates for patients with indolent lymphoma who were treated with this treatment as
the first systemic therapy for their disease with response rates and survival observed for
similar patients treated in published trials. V. Determine the quality of life associated
with this treatment in this patient population.
OUTLINE: This is an open label study. Patients receive oral cyclophosphamide daily and
rituximab (IDEC-C2B8 monoclonal antibody) IV on days 1, 8, 15, and 22 for the first 4-week
course. Patients then receive oral cyclophosphamide daily and rituximab IV monthly until 2
months beyond maximum response. Patients are treated for at least 6 months but no more than
18 months in the absence of disease progression. Patients are followed every 3 months for 2
years, then every 6 months for the next 2 years, and then annually for up to 10 years.
PROJECTED ACCRUAL: There will be 20-40 patients accrued into this study.
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV indolent B-cell lymphoma
Diffuse small cleaved cell lymphoma Follicular small cleaved cell lymphoma Follicular
mixed cell lymphoma Follicular large cell lymphoma At least 1 lymph node or visceral
lesion at least 2 cm in diameter
PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Lymphocyte count less than 5,000/mm3 Hepatic: Not specified
Renal: Not specified Other: No active infection No concurrent life threatening disease Not
pregnant Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma
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3
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