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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002003
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1992

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002003 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas

To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
  • Lymphoma, Non-Hodgkin
  • HIV Infections
  • Drug: Mitoxantrone hydrochloride
  • Drug: Etoposide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
Not Provided
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002003
055A, 3-100
Not Provided
Not Provided
Lederle Laboratories
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
March 1992

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