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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.
First Received: November 2, 1999   Last Updated: June 23, 2005   History of Changes
Sponsored by: Lederle Laboratories
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002003
  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 II

Study Type: Interventional
Study Design: Treatment, Dose Comparison, Efficacy Study
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:

  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
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
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, United States, 10019
New York Univ Med Ctr
New York, New York, United States, 10016
Sponsors and Collaborators
Lederle Laboratories
  More Information

No publications provided

Study ID Numbers: 055A, 3-100
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002003     History of Changes
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

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Immunoproliferative Disorders
Acquired Immunodeficiency Syndrome
Etoposide phosphate
Immunologic Deficiency Syndromes
Lymphoma, Large-cell, Immunoblastic
Virus Diseases
Lymphatic Diseases
HIV Infections
Lymphoma, Large-Cell, Immunoblastic
Sexually Transmitted Diseases
Peripheral Nervous System Agents
Analgesics
Mitoxantrone
Lymphoma, Large-cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Etoposide
Lymphoma
Retroviridae Infections

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Infection
Etoposide phosphate
Sensory System Agents
Therapeutic Uses
Lymphoma, Large-Cell, Immunoblastic
Analgesics
Retroviridae Infections
Lymphoma
Etoposide
RNA Virus Infections
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Acquired Immunodeficiency Syndrome
Pharmacologic Actions
Immunologic Deficiency Syndromes
Virus Diseases
Lymphatic Diseases
Neoplasms
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Peripheral Nervous System Agents
Mitoxantrone
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on July 02, 2009