Combination Chemotherapy Plus Filgrastim 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

Toxicity [ Designated as safety issue: Yes ]
Effects of treatment on response rate, time to disease progression, and survival [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00032149 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase I/II trial to study the effectiveness of combining filgrastim with combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.

Detailed Description

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.

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.

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

Study Phase

Phase I, Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Lymphoma

Intervention ^ICMJE

Biological: bleomycin sulfate
Biological: filgrastim
Drug: cyclophosphamide
Drug: etoposide
Drug: mitoxantrone hydrochloride
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

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

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

PRIOR CONCURRENT THERAPY:

Biologic:

Not specified

Chemotherapy:

Not specified

Endocrine:

Not specified

Radiotherapy:

Not specified

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

NCT00032149

Responsible Party

Study ID Numbers ^ICMJE

CDR0000069261, BNLI-GOODRISKHIV, EU-20144

Study Sponsor ^ICMJE

Lymphoma Trials Office

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Ruth Pettengell, MD

St George's, University of London

Information Provided By

National Cancer Institute (NCI)

Verification Date

March 2007

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