Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas

June 23, 2005 updated by: Lederle Laboratories
To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 071032714
        • UMDNJ - New Jersy Med School
    • New York
      • New York, New York, United States, 10016
        • New York Univ Med Ctr
      • New York, New York, United States, 10019
        • Saint Luke's - Roosevelt Hosp Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

Patients must have the following:

  • Positive HIV antibody, positive HIV culture or antigen capture, or prior diagnosis of AIDS by the CDC criteria.
  • Diagnosis by pathological examination of large cell or immunoblastic lymphoma within measurable or evaluable disease.
  • Pneumocystis carinii pneumonia (PCP) prophylaxis during the course of the study.
  • Signed written informed consent.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
  • Stage IE Central Nervous System lymphomas.

Patients with the following are excluded:

  • More than one previous treatment for lymphoma.
  • Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
  • Conditions that preclude obtaining an informed consent.
  • Not accessible for scheduled treatment visits or follow-up.
  • Stage IE Central Nervous System (CNS) lymphomas.

Prior Medication:

Excluded within 2 weeks of study entry:

  • Zidovudine.
  • Excluded:
  • Doxorubicin dosing = or > 300 mg/m2.

Prior Treatment:

Excluded:

  • Received more than one previous treatment regimen for lymphoma.

Required:

  • Prophylactic treatment for Pneumocystis carinii pneumonia (PCP) prophylaxis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lederle Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

March 1, 1992

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 055A
  • 3-100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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