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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin, HIV Infections

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

055A

NCT ID:

NCT00002003

Start Date:

Completion Date:

Related Keywords:

  • Lymphoma, Non-Hodgkin
  • HIV Infections
  • Mitoxantrone
  • Lymphoma, Large-Cell
  • Etoposide
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
  • Acquired Immunodeficiency Syndrome
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

Saint Luke's - Roosevelt Hosp CtrNew York, New York  10025
New York Univ Med CtrNew York, New York  10016
UMDNJ - New Jersy Med SchoolNewark, New Jersey  071032714