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

Primary Purpose

Lymphoma, Non-Hodgkin, HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Mitoxantrone hydrochloride
Etoposide
Sponsored by
Lederle Laboratories
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non-Hodgkin focused on measuring Mitoxantrone, Lymphoma, Large-Cell, Etoposide, Acquired Immunodeficiency Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UMDNJ - New Jersy Med School
  • New York Univ Med Ctr
  • Saint Luke's - Roosevelt Hosp Ctr

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Lederle Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00002003
Brief Title
Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
Official Title
Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
Study Type
Interventional

2. Study Status

Record Verification Date
March 1992
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Lederle Laboratories

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, HIV Infections
Keywords
Mitoxantrone, Lymphoma, Large-Cell, Etoposide, Acquired Immunodeficiency Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Mitoxantrone hydrochloride
Intervention Type
Drug
Intervention Name(s)
Etoposide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UMDNJ - New Jersy Med School
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032714
Country
United States
Facility Name
New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Saint Luke's - Roosevelt Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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