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

Launched by LEDERLE LABORATORIES · Aug 30, 2001

Keywords

ClinConnect Summary

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Gender

ALL

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.