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

Lymphoma Trials Office

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Lymphoma

Treatments: Drug: prednisolone; Biological: filgrastim; Drug: etoposide; Drug: cyclophosphamide; Drug: vincristine sulfate; Drug: mitoxantrone hydrochloride; Biological: bleomycin sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT00032149

CDR0000069261

BNLI-GOODRISKHIV

EU-20144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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