Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Larg… (NCT00002003) | Clinical Trial Compass
CompletedPhase 2
Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
United States
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.