This trial is active, not recruiting.

Condition lymphoma
Treatments bleomycin sulfate, filgrastim, cyclophosphamide, etoposide, mitoxantrone hydrochloride, prednisolone, vincristine sulfate
Phase phase 1/phase 2
Sponsor Lymphoma Trials Office
Start date October 2001
Trial size 30 participants
Trial identifier NCT00032149, BNLI-GOODRISKHIV, CDR0000069261, EU-20144


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).