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

Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma, Non-Hodgkin; HIV Infections

Intervention: Mitoxantrone hydrochloride (Drug); Etoposide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Lederle Laboratories

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

UMDNJ - New Jersy Med School, Newark, New Jersey 071032714, United States

New York Univ Med Ctr, New York, New York 10016, United States

Saint Luke's - Roosevelt Hosp Ctr, New York, New York 10019, United States

Additional Information


Last updated: June 23, 2005

Page last updated: August 23, 2015

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