NCT00002003

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

March 1, 1992

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

Lymphoma, Non-HodgkinHIV Infections

Keywords

MitoxantroneLymphoma, Large-CellEtoposideAcquired Immunodeficiency Syndrome

Interventions

Mitoxantrone hydrochlorideDRUG
EtoposideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UMDNJ - New Jersy Med School

Newark, New Jersey, 071032714, United States

Location

New York Univ Med Ctr

New York, New York, 10016, United States

Location

Saint Luke's - Roosevelt Hosp Ctr

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Lymphoma, Non-HodgkinHIV InfectionsDendritic Cell Sarcoma, InterdigitatingAcquired Immunodeficiency Syndrome

Interventions

MitoxantroneEtoposide

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesHistiocytic Disorders, MalignantHistiocytosisSlow Virus Diseases

Intervention Hierarchy (Ancestors)

AnthraquinonesAnthronesAnthracenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsQuinonesPolycyclic CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesGlycosidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1992-03

Locations

US(3)