ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Rituximab Plus Combination Chemotherapy in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

This study is ongoing, but not recruiting participants.

Sponsored by: Lymphoma Trials Office
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031902
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: bleomycin
Drug: prednisolone
Drug: rituximab
Drug: vincristine sulfate
Phase I

MedlinePlus related topics:   AIDS    Cancer    Lymphoma   

Drug Information available for:   Prednisolone    6-Methylprednisolone    Depo-medrol    Medrol veriderm    Methylprednisolone    Methylprednisolone hemisuccinate    Methylprednisolone Sodium Succinate    Prednisolone acetate    Prednisolone sodium phosphate    Prednisolone Sodium Succinate    Vincristine sulfate    Vincristine    Rituximab    Bleomycin    Bleomycin sulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Rituxumab Combined With Chemotherapy (PVB) For Poor Prognosis HIV-Related Non-Hodgkin's Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 2001

Detailed Description:

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00031902

Locations
United Kingdom
Chelsea Westminster Hospital    
      London, United Kingdom, SW10 9NH
United Kingdom, England
St. George's Hospital    
      London, England, United Kingdom, SW17 0QT

Sponsors and Collaborators
Lymphoma Trials Office

Investigators
Study Chair:     Ruth Pettengell, MD     St. George's Hospital    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000069238, BNLI-POORRISKHIV, EU-20145
First Received:   March 8, 2002
Last Updated:   August 23, 2008
ClinicalTrials.gov Identifier:   NCT00031902
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
AIDS-related peripheral/systemic 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

Study placed in the following topic categories:
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Methylprednisolone
Rituximab
Acquired Immunodeficiency Syndrome
Lymphoma, small cleaved-cell, diffuse
Vincristine
Methylprednisolone acetate
Prednisolone acetate
Lymphoblastic lymphoma
Bleomycin
Small non-cleaved cell lymphoma
Lymphoma, large-cell, immunoblastic
Lymphoma, large-cell
Lymphatic Diseases
HIV Infections
Prednisolone
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antimitotic Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Tubulin Modulators
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on November 30, 2008




Links to all studies - primarily for crawlers