Rituximab Plus Combination Chemotherapy 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 February 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00031902
First received: March 8, 2002
Last updated: September 19, 2013
Last verified: February 2003

March 8, 2002
September 19, 2013
October 2001
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Complete list of historical versions of study NCT00031902 on ClinicalTrials.gov Archive Site
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Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies such as rituximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining rituximab with chemotherapy may kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of rituximab plus combination chemotherapy in treating patients who have HIV-related non-Hodgkin's lymphoma.

OBJECTIVES:

  • Determine the response rate of patients with poor-prognosis, HIV-related non-Hodgkin's lymphoma treated with rituximab combined with prednisolone, vincristine, and bleomycin.
  • Determine the toxicity of this regimen in these patients.
  • Determine the time to progression and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive chemotherapy comprising vincristine IV and bleomycin IV on day 1 and oral prednisolone every other day beginning on day 1. Treatment repeats every 3 weeks for 6 courses. Patients also receive rituximab on days 14, 21, 28, and 35. Patients who achieve complete response (CR) receive 2 additional courses of chemotherapy after CR.

Patients are followed every 1-2 months.

PROJECTED ACCRUAL: A total of 10-20 patients will be accrued for this study.

Interventional
Phase 1
Primary Purpose: Treatment
Lymphoma
  • Biological: bleomycin sulfate
  • Biological: rituximab
  • 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
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DISEASE CHARACTERISTICS:

  • Diagnosis of poor-prognosis, HIV-related non-Hodgkin's lymphoma (HIV-NHL)

    • Previously untreated
  • More than 1 of the following criteria:

    • Prior diagnosis of AIDS
    • ECOG performance status 3-4
    • CD4 count less than 100/mm3
  • No primary cerebral lymphoma

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • See Disease Characteristics

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for HIV-NHL
  • At least 1 year since prior chemotherapy for Kaposi's sarcoma (KS)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior radiotherapy for HIV-NHL allowed
  • At least 1 year since prior radiotherapy for KS

Surgery:

  • Not specified
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00031902
CDR0000069238, BNLI-POORRISKHIV, EU-20145
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Lymphoma Trials Office
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Study Chair: Ruth Pettengell, MD St. George's Hospital
National Cancer Institute (NCI)
February 2003

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