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

Sponsor

Lederle Laboratories (Industry)

Overall Status

Completed

CT.gov ID

NCT00002003

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Non-Hodgkin HIV Infections	Drug: Mitoxantrone hydrochloride Drug: Etoposide	Phase 2

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UMDNJ - New Jersy Med School	Newark	New Jersey	United States	071032714
2	New York Univ Med Ctr	New York	New York	United States	10016
3	Saint Luke's - Roosevelt Hosp Ctr	New York	New York	United States	10019