Clinical trial · Interventional
Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma
Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines
NCT00427414CI-TRIAL-00017679terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to slow accrual.
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as liposomal daunorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This clinical trial is studying how well liposomal daunorubicin works in treating patients with HIV-related Kaposi's sarcoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| liposomal daunorubicin citrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- liposomal daunorubicin citrate
- description
- 40 mg/m2 Days 1 and 15 every 28 days x 3 cycles
- interventionNames
- Drug: liposomal daunorubicin citrate
Primary outcomes (1)
- measure
- Effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors
- timeFrame
- 24-48 hours after the first treatment
Secondary outcomes (2)
- measure
- Effect of treatment on KSHV viral gene expression in peripheral blood mononuclear cells
- timeFrame
- 24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed Kaposi's sarcoma (KS) involving the following: * Skin * Lymph nodes (palpable disease only) * Oral cavity * Must have ≥ 5 measurable, previously nonirradiated, cutaneous lesions that can be used as indicator lesions * Must have 2 lesions ≥ 5 x 5 mm that are accessible for 4 mm punch biopsy * Serologically confirmed HIV positivity * Concurrent antiretroviral therapy required, except for patients who have exhausted all available treatment options * Must be on a stable dose for ≥ 4 weeks PATIENT CHARACTERISTICS: * Life expectancy ≥ 3 months * No other neoplasia requiring cytotoxic therapy * Not pregnant or nursing * Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior anthracycline therapy * At least 4 weeks since prior antineoplastic treatment for KS, including any of the following: * Chemotherapy (6 weeks for nitrosoureas or mitomycin C) * Radiotherapy * Local therapy * Biological therapy * Investigational therapy * At least 60 days since prior local therapy of any KS indicator lesion unless lesion has clearly progressed since treatment * No other concurrent investigational drugs, cytotoxic chemotherapy, or KS-specific treatment
References
Publications (0)
Data not yet available
No reference posted for this study.