Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
| 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
30A 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 Lead Organizations
Lymphoma Trials Office
 | | | ||
| Ruth Pettengell, MD, Protocol chair | |
| ||
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| 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 | |
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| 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.
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