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.

Condition	Treatment or Intervention	Phase
AIDS-Related Lymphoma	Drug: bleomycin  Drug: cyclophosphamide  Drug: etoposide  Drug: filgrastim  Drug: mitoxantrone  Drug: prednisolone  Drug: vincristine  Procedure: biological response modifier therapy  Procedure: chemotherapy  Procedure: colony-stimulating factor therapy  Procedure: cytokine therapy	Phase I Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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

United Kingdom, England
      Cheltenham General Hospital, Cheltenham,  England,  GL53 7AN,  United Kingdom; Recruiting
      King's College Hospital, London,  England,  NW1 2DA,  United Kingdom; Recruiting
      St. Georges Hospital Medical School, London,  England,  SW17 ORE,  United Kingdom; Recruiting
United Kingdom, Scotland
      Western General Hospital, Edinburgh,  Scotland,  EH4 2XU,  United Kingdom; Recruiting

Study chairs or principal investigators

Ruth Pettengell, MD,  Study Chair,  St. Georges Hospital Medical School   

Study ID Numbers:  CDR0000069261; BNLI-GOODRISKHIV; EU-20144; NCT00032149
Record last reviewed:  January 2005
Last Updated:  February 7, 2005
Record first received:  March 8, 2002
ClinicalTrials.gov Identifier:  NCT00032149
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08