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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lederle Laboratories
• Treatments: Etoposide; Etoposide phosphate; Mitoxantrone

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.