Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma
This study has been completed.
Sponsor:
Lederle Laboratories
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002259
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: August 1991
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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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Primary Purpose: Treatment |
| Official Title: | Phase II Study of Intravenous Novantrone(R) in the Treatment of AIDS Related Kaposi's Sarcoma |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Classic Kaposi Sarcoma
Malignant Mesenchymal Tumor
Soft Tissue Sarcoma
U.S. FDA Resources
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:
- 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
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: NCT00002259
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
| ClinicalTrials.gov Identifier: | NCT00002259 History of Changes |
| Other Study ID Numbers: | 055B, 3-102 |
| 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 Acquired Immunodeficiency Syndrome |
Additional relevant MeSH terms:
|
Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Mitoxantrone Analgesics Antineoplastic Agents Central Nervous System Agents Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses Topoisomerase II Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on February 27, 2015