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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002003
• Other study ID #: 055A
• Secondary ID: 3-100
• Status: Completed
• Phase: Phase 2
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: March 1992
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections
• Lymphoma
• Lymphoma, Large-Cell, Immunoblastic
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• Mitoxantrone hydrochloride

• Etoposide

Locations

Country	Name	City	State
United States	New York Univ Med Ctr	New York	New York
United States	Saint Luke's - Roosevelt Hosp Ctr	New York	New York
United States	UMDNJ - New Jersy Med School	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Lederle Laboratories

Country where clinical trial is conducted

United States,