Status:
TERMINATED
Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma
Lead Sponsor:
AIDS Malignancy Consortium
Collaborating Sponsors:
National Cancer Institute (NCI)
The Emmes Company, LLC
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
OBJECTIVES: Primary * Determine the effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors of patients with HIV-related Kaposi's ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT00427414
Start Date
September 1 2008
End Date
November 1 2011
Last Update
April 29 2015
Active Locations (3)
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1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
2
Centro de Referencia e Tratamento DST/AIDS
São Paulo, São Paulo, Brazil, 04121000
3
Instituto De Infectologia Emilio Ribas Hospital
Cerqueira Cesar - Sao Paulo/SP, Brazil, 01246-900