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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00002003
Enrollment
Unknown
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, Lymphoma, Non-Hodgkin

Keywords

Mitoxantrone, Lymphoma, Large-Cell, Etoposide, Acquired Immunodeficiency Syndrome

Brief 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.

Interventions

DRUGMitoxantrone hydrochloride
DRUGEtoposide

Sponsors

Lederle Laboratories
Lead SponsorINDUSTRY

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026