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NCT00001059 · ClinicalTrials.gov registry record · Phase 2
Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT00001059 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 120 participants.
The verdict
NCT00001059, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life. Liposomal formulations of chemotherapeutic agents increase drug accumulation in tumors, which permits disease palliation at relatively low doses and thus decreases some of the dose-limiting toxicity. Multi-agent therapy is considered to be more effective than single-agent therapy; therefore, DOX-SL will be combined with bleomycin and vincristine.
Interventions
- DRUG Filgrastim
- DRUG Doxorubicin hydrochloride (liposomal)
- DRUG Bleomycin sulfate
- DRUG Vincristine sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Est. Completion | 1998-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001059
The ClinicalTrials.gov registry entry for NCT00001059 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Filgrastim is the first listed.
NCT00001059 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001059 about?
NCT00001059 is a clinical study titled "Comparison of Liposomal Doxorubicin Used Alone or in Combination With Bleomycin Plus Vincristine in the Treatment of Kaposi's Sarcoma in Patients With AIDS". To evaluate the safety and efficacy of liposomal doxorubicin hydrochloride ( DOX-SL ) alone or in combination with bleomycin and vincristine in the long-term treatment of AIDS-related Kaposi's sarcoma. To determine whether the 3-drug combination enhances progression-free survival and quality of life...
What is the current status of trial NCT00001059?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. Estimated completion is 1998-08.
What interventions are being tested in trial NCT00001059?
The interventions under investigation include: Filgrastim (DRUG), Doxorubicin hydrochloride (liposomal) (DRUG), Bleomycin sulfate (DRUG), Vincristine sulfate (DRUG).
Who is sponsoring clinical trial NCT00001059?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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