Rituximab Plus Cyclophosphamide in Treating Patients With Indolent Stage III or Stage IV Non-Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title:

Rituximab Anti-CD20 Monoclonal Antibody Plus Oral Cyclophosphamide as Initial Treatment of Indolent Lymphoma

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00003605
• Other study ID #: CDR0000066680
• Secondary ID: CBRG-9801GENENTE
• Status: Withdrawn
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: August 17, 2015
• Start date: May 1998
• Est. completion date: January 2000

Study information

• Verified date: August 2015
• Source: Hoag Memorial Hospital Presbyterian
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2000
• Est. primary completion date: January 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Biological:
• rituximab

Drug:
• cyclophosphamide

Locations

Country	Name	City	State
United States	Bloomington Hospital	Bloomington	Indiana
United States	St. Joseph Regional Cancer Center	Bryan	Texas
United States	Hoag Memorial Hospital Presbyterian	Newport Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
Hoag Memorial Hospital Presbyterian	Cancer Biotherapy Research Group

Country where clinical trial is conducted

United States,