Lymphoma
Conditions
Keywords
AIDS-related peripheral/systemic lymphoma, AIDS-related primary CNS lymphoma, AIDS-related diffuse large cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related small noncleaved cell lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related lymphoblastic 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.
Interventions
BIOLOGICALbleomycin sulfate
BIOLOGICALfilgrastim
DRUGcyclophosphamide
DRUGetoposide
DRUGmitoxantrone hydrochloride
DRUGprednisolone
DRUGvincristine sulfate
Sponsors
Lymphoma Trials Office
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Toxicity | — |
| Effects of treatment on response rate, time to disease progression, and survival | — |
Countries
United Kingdom
Outcome results
None listed