Clinical Trials (PDQ®) - National Cancer Institute

Page Options

Clinical Trial Questions?

Get Help:

	Quick Links


	Help Using the NCI Clinical Trials Search Form Educational Materials About Clinical Trials About NCI's Cancer Clinical Trials Registry Dictionary of Cancer Terms NCI Drug Dictionary

Phase I/II Pilot Study of Mitoxantrone, Cyclophosphamide, Etoposide, Vincristine, Bleomycin, Prednisolone, and Filgrastim (G-CSF) in Patients With Good-Prognosis HIV-Related Non-Hodgkin's Lymphoma

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II, Phase I Treatment Closed 18 and over Other BNLI-GOODRISKHIV
EU-20144, NCT00032149

Objectives

Determine the toxicity of mitoxantrone, cyclophosphamide, etoposide, vincristine, bleomycin, prednisolone, and filgrastim (G-CSF) in patients with good-prognosis (defined by the study as having 1 adverse prognostic factor) HIV-related non-Hodgkin's lymphoma.
Determine the effects of this regimen on response rate, time to disease progression, and survival in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed previously untreated HIV-related non-Hodgkin's lymphoma with 1 of the following:
- Prior diagnosis of acquired immune deficiency syndrome (AIDS)
- CD4 count < 100,000/mm3
- ECOG performance status > 2

Prior/Concurrent Therapy:

Biologic:

Not specified

Chemotherapy:

Not specified

Endocrine:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Patient Characteristics:

Age:

18 and over

Performance status:

See Disease Characteristics

Life expectancy:

Not specified

Hematopoietic:

See Disease Characteristics

Hepatic:

Not specified

Renal:

Not specified

Expected Enrollment

A total of 15-30 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Toxicity
Effects of treatment on response rate, time to disease progression, and survival

Outline

This is a multicenter study.

Patients receive mitoxantrone IV, cyclophosphamide IV, and etoposide IV on day 1; and vincristine IV and bleomycin IV on day 8. Patients also receive prednisolone daily on weeks 1-4 and then every other day on weeks 5-16. Patients receive filgrastim (G-CSF) subcutaneously on days 6-12. Treatment repeats every 2 weeks for up to 8 courses (16 weeks) in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) receive 4 courses beyond CR or PR.

Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Lymphoma Trials Office

Ruth Pettengell, MD, Protocol chair
Ph: 44-208-725-5454
Email: r.pettengell@sgul.ac.uk

Registry Information

Official Title		Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma

Trial Start Date		2001-10-01

Registered in ClinicalTrials.gov		NCT00032149

Date Submitted to PDQ		2002-01-23

Information Last Verified		2007-03-27

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.