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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.
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: 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

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

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:

  • 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

No publications provided

Study ID Numbers: 055B, 3-102
Study First Received: November 2, 1999
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00002259     History of Changes
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
Acquired Immunodeficiency Syndrome
Sarcoma, Kaposi
Immunologic Deficiency Syndromes
Kaposi Sarcoma
Herpesviridae Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Malignant Mesenchymal Tumor
HIV Infections
Sexually Transmitted Diseases
Sarcoma
DNA Virus Infections
Peripheral Nervous System Agents
Analgesics
Mitoxantrone
Retroviridae Infections

Additional relevant MeSH terms:
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Infection
Neoplasms, Connective and Soft Tissue
Sensory System Agents
Therapeutic Uses
Neoplasms, Vascular Tissue
Analgesics
Retroviridae Infections
RNA Virus Infections
Neoplasms by Histologic Type
Immune System Diseases
Sarcoma, Kaposi
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Pharmacologic Actions
Herpesviridae Infections
Virus Diseases
Neoplasms
HIV Infections
Sexually Transmitted Diseases
Lentivirus Infections
Sarcoma
DNA Virus Infections
Peripheral Nervous System Agents
Mitoxantrone
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009