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

Completed · Phase 2

Conditions studied: Lymphoma, Non-Hodgkin, HIV Infections

In brief

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

Key facts

Study ID

NCT00002003

Run by

Lederle Laboratories

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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