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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002003
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: March 1992
  Purpose

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 Intervention Phase
Lymphoma, Non-Hodgkin
HIV Infections
Drug: Mitoxantrone hydrochloride
Drug: Etoposide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
Official Title: Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002003

Locations
United States, New Jersey
UMDNJ - New Jersy Med School
Newark, New Jersey, United States, 071032714
United States, New York
New York Univ Med Ctr
New York, New York, United States, 10016
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10019
Sponsors and Collaborators
Lederle Laboratories
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002003     History of Changes
Other Study ID Numbers: 055A, 3-100
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Mitoxantrone
Lymphoma, Large-Cell
Etoposide
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunologic Deficiency Syndromes
Immunoproliferative Disorders
Lentivirus Infections
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases
Etoposide
Etoposide phosphate
Mitoxantrone
Analgesics
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014