Combination Chemotherapy Plus Interferon Alfa or Rituximab in Treating Patients With Stage III or Stage IV Lymphoma
| Status: | Withdrawn |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | June 1998 |
| End Date: | January 2000 |
Phase II Trials of CHOP Chemotherapy and Interferon Alpha or Rituximab Anti-CD20 Monoclonal Antibody as Initial Treatment of Patients With Stage III and IV High-Risk Indolent B-Cell Lymphoma and Intermediate Grade B-Cell Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Combining interferon alfa or the monoclonal antibody rituximab
with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy plus
interferon alfa or rituximab in treating patients who have high risk stage III or stage IV
lymphoma.
so they stop growing or die. Combining interferon alfa or the monoclonal antibody rituximab
with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy plus
interferon alfa or rituximab in treating patients who have high risk stage III or stage IV
lymphoma.
OBJECTIVES: I. Determine the toxicity of cyclophosphamide, doxorubicin, vincristine, and
prednisone (CHOP) with either interferon alfa or rituximab in patients with stage III or IV
high risk indolent or intermediate B-cell lymphoma. II. Determine the objective tumor
response rate and duration of response for these regimens in these patients. III. Determine
the failure free survival and overall survival for these patients on these regimens. IV.
Compare the response rate and survival rate of these patients on these regimens to similar
patients treated in published studies. V. Compare the toxicities of these regimens in these
patients. VI. Determine the quality of life of these patients on these regimens.
OUTLINE: This is a multicenter study. Patients are assigned to one of two treatment arms:
Arm I: Patients receive rituximab IV on day 0, and cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1, followed by oral prednisone on days 1-5. Arm II: Patients receive
interferon alfa subcutaneously on days 22-26, and cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1, followed by oral prednisone on days 1-5. Treatment repeat every 28
days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and prior to chemotherapy for each course. Patients
are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for
up to 10 years.
PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per treatment arm) will be accrued for
this study.
prednisone (CHOP) with either interferon alfa or rituximab in patients with stage III or IV
high risk indolent or intermediate B-cell lymphoma. II. Determine the objective tumor
response rate and duration of response for these regimens in these patients. III. Determine
the failure free survival and overall survival for these patients on these regimens. IV.
Compare the response rate and survival rate of these patients on these regimens to similar
patients treated in published studies. V. Compare the toxicities of these regimens in these
patients. VI. Determine the quality of life of these patients on these regimens.
OUTLINE: This is a multicenter study. Patients are assigned to one of two treatment arms:
Arm I: Patients receive rituximab IV on day 0, and cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1, followed by oral prednisone on days 1-5. Arm II: Patients receive
interferon alfa subcutaneously on days 22-26, and cyclophosphamide IV, doxorubicin IV, and
vincristine IV on day 1, followed by oral prednisone on days 1-5. Treatment repeat every 28
days for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and prior to chemotherapy for each course. Patients
are followed every 3 months for 2 years, every 6 months for 2 years, and then annually for
up to 10 years.
PROJECTED ACCRUAL: A total of 40-80 patients (20-40 per treatment arm) will be accrued for
this study.
DISEASE CHARACTERISTICS: Histologically confirmed high risk (stage III or IV) indolent or
intermediate (stage II to IV) B-cell lymphoma Small cleaved cell lymphoma Waldenstrom's
macroglobulinemia Follicular small cleaved cell or mixed cell Follicular large cell
Diffuse Immunoblastic High risk is defined as: Increased LDH OR Increased
beta-2-microglobulin OR B symptoms OR Bulky disease of greater than 7 cm in diameter OR
Extranodal disease other than blood or bone marrow involvement OR Mantle zone histology 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: Not specified Hepatic: Not specified Renal: Not specified
Other: No active infection or other medical condition this is lifethreatening Not pregnant
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: No prior therapy for lymphoma
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