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Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma

This study has been completed.

Sponsored by: Lederle Laboratories
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002259
  Purpose

To study the toxicity and efficacy of IV mitoxantrone hydrochloride (Novantrone) in AIDS-related Kaposi's sarcoma.


Condition Intervention Phase
Sarcoma, Kaposi
HIV Infections
Drug: Mitoxantrone hydrochloride
Phase II

MedlinePlus related topics:   AIDS    Kaposi's Sarcoma    Soft Tissue Sarcoma   

ChemIDplus related topics:   Mitoxantrone hydrochloride    Mitoxantrone   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Dose Comparison, Efficacy Study
Official Title:   Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
  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:

  • Biopsy proven Kaposi's sarcoma in advanced stages.
  • Positive HIV antibody, HIV culture or antigen capture or T4 cells < 500 in a patient with AIDS risk factor.
  • Informed consent and availability for follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

  • Uncontrolled opportunistic infection.
  • Any medical, surgical or psychiatric condition which would constitute a contraindication to the use of mitoxantrone.

Concurrent Medication:

Excluded:

  • Zidovudine (AZT).

Patients with the following are excluded:

  • Uncontrolled opportunistic infection.
  • Unable to give informed consent.
  • Any medical, surgical or psychiatric condition which would constitute a contraindication to the use of mitoxantrone.

Prior Medication:

Excluded:

  • More than one form of chemotherapy regimen.
  • Doxorubicin therapy > 300 mg/m2.

Prior Treatment:

Excluded:

  • Previous therapy consisting of more than one modality of therapy (e.g., chemotherapy plus radiotherapy or more than one form of chemotherapy regimen.)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002259

Locations
United States, New York
Saint Luke's - Roosevelt Hosp Ctr    
      New York, New York, United States, 10019

Sponsors and Collaborators
Lederle Laboratories
  More Information


Study ID Numbers:   055B, 3-102
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002259
Health Authority:   United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Mitoxantrone  
Acquired Immunodeficiency Syndrome  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Malignant mesenchymal tumor
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Soft tissue sarcomas
Immunologic Deficiency Syndromes
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Mitoxantrone
Retroviridae Infections

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Infection
Pharmacologic Actions
Neoplasms
Sensory System Agents
Therapeutic Uses
Lentivirus Infections
Neoplasms, Vascular Tissue
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2008




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