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

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00002003 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
Official Title ^ICMJE	Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
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.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Dose Comparison, Efficacy Study
Condition ^ICMJE	Lymphoma, Non-Hodgkin HIV Infections
Intervention ^ICMJE	Drug: Mitoxantrone hydrochloride Drug: Etoposide
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00002003
Responsible Party
Study ID Numbers ^ICMJE	055A, 3-100
Study Sponsor ^ICMJE	Lederle Laboratories
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	NIH AIDS Clinical Trials Information Service
Verification Date	March 1992
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP