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

Lederle Laboratories

Status and phase: Completed; Phase 2

Conditions: HIV Infections; Lymphoma, Non-Hodgkin

Treatments: Drug: Etoposide; Drug: Mitoxantrone hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00002003

055A

3-100

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.