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

Tracking Information

First Received Date ^ICMJE

March 8, 2002

Last Updated Date

April 18, 2009

Start Date ^ICMJE

October 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00031902 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Lymphoma

Intervention ^ICMJE

Biological: bleomycin sulfate
Biological: rituximab
Drug: prednisolone
Drug: vincristine sulfate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00031902

Responsible Party

Study ID Numbers ^ICMJE

CDR0000069238, BNLI-POORRISKHIV, EU-20145

Study Sponsor ^ICMJE

Lymphoma Trials Office

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Ruth Pettengell, MD

St. George's Hospital

Information Provided By

National Cancer Institute (NCI)

Verification Date

February 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP