Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

Lymphoma Clinical Trial

Official title:

Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00031902
• Other study ID #: CDR0000069238
• Secondary ID: BNLI-POORRISKHIV
• Status: Active, not recruiting
• Phase: Phase 1
• First received: March 8, 2002
• Last updated: September 19, 2013
• Start date: October 2001

Study information

• Verified date: February 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-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 rituximab with chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.

Description:

OBJECTIVES:

• Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin.

• Determine the toxicity of this regimen in these patients.

• Determine the time to progression and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR.

Patients are followed every 1-2 months.

PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of poor-prognosis, HIV-related non-Hodgkin's lymphoma (HIV-NHL)

• Previously untreated

• More than 1 of the following criteria:

• Prior diagnosis of AIDS

• ECOG performance status 3-4

• CD4 count less than 100/mm3

• No primary cerebral lymphoma

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• See Disease Characteristics

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for HIV-NHL

• At least 1 year since prior chemotherapy for Kaposi's sarcoma (KS)

Endocrine therapy:

• Not specified

Radiotherapy:

• Prior radiotherapy for HIV-NHL allowed

• At least 1 year since prior radiotherapy for KS

Surgery:

• Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Biological:
• bleomycin sulfate

• rituximab

Drug:
• prednisolone

• vincristine sulfate

Locations

Country	Name	City	State
United Kingdom	Chelsea Westminster Hospital	London
United Kingdom	St. George's Hospital	London	England

Sponsors (1)

Lead Sponsor	Collaborator
Lymphoma Trials Office

Country where clinical trial is conducted

United Kingdom,