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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

Thank you

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 Ctr New York, New York  10025
New York Univ Med Ctr New York, New York  10016
UMDNJ - New Jersy Med School Newark, New Jersey  071032714