Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma

• Status: Terminated
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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: This clinical trial is studying how well liposomal daunorubicin works in treating patients with HIV-related Kaposi's sarcoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AIDS Malignancy Consortium
• Collaborators: National Cancer Institute (NCI); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Citric Acid; Daunorubicin

Criteria

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