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Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines


Phase 1
18 Years
N/A
Not Enrolling
Both
Sarcoma

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Trial Information

Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines


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 sarcoma.

Secondary

- Determine the effect of this drug on KSHV viral gene expression in peripheral blood
mononuclear cells.

- Determine the effect of this drug on KSHV viral load in plasma.

- Correlate viral load with viral gene expression and/or tumor regression in these
patients.

OUTLINE: This is a multicenter, pilot study.

Patients receive liposomal daunorubicin citrate IV days 1 and 15. Treatment repeats every 4
weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity.

Biopsies are performed at baseline and once during treatment to evaluate Kaposi's sarcoma-
associated herpes virus (KSHV) viral gene expression in tumors and skin tissue using reverse
transcriptase-quantitative polymerase chain reaction. Blood samples are collected at
baseline and periodically during treatment to evaluate KSHV viral gene expression in
peripheral blood mononuclear cells and viral load in plasma.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Inclusion 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors

Outcome Time Frame:

24-48 hours after the first treatment

Safety Issue:

No

Principal Investigator

Juan Carlos Ramos, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CDR0000526564

NCT ID:

NCT00427414

Start Date:

September 2008

Completion Date:

November 2011

Related Keywords:

  • Sarcoma
  • AIDS-related Kaposi sarcoma
  • recurrent Kaposi sarcoma
  • Sarcoma, Kaposi
  • Sarcoma

Name

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136