Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
NCT ID: NCT00002003
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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Mitoxantrone hydrochloride
Etoposide
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
ALL
No
Sponsors
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Lederle Laboratories
INDUSTRY
Locations
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UMDNJ - New Jersy Med School
Newark, New Jersey, United States
New York Univ Med Ctr
New York, New York, United States
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States
Countries
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Other Identifiers
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3-100
Identifier Type: -
Identifier Source: secondary_id
055A
Identifier Type: -
Identifier Source: org_study_id