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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00032149
First received: March 8, 2002
Last updated: September 19, 2013
Last verified: March 2007

March 8, 2002
September 19, 2013
October 2001
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  • Toxicity [ Designated as safety issue: Yes ]
  • Effects of treatment on response rate, time to disease progression, and survival [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00032149 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy Plus Filgrastim in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
Pilot Study Of PMitCEBO Plus G-CSF In Good-Prognosis HIV-Related Lymphoma

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.

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.

Interventional
Phase 1
Phase 2
Primary Purpose: Treatment
Lymphoma
  • Biological: bleomycin sulfate
  • Biological: filgrastim
  • Drug: cyclophosphamide
  • Drug: etoposide
  • Drug: mitoxantrone hydrochloride
  • Drug: prednisolone
  • Drug: vincristine sulfate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00032149
CDR0000069261, BNLI-GOODRISKHIV, EU-20144
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Lymphoma Trials Office
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Study Chair: Ruth Pettengell, MD St George's, University of London
National Cancer Institute (NCI)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP