Clinical trial NCT00427414: Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma
Official title: Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Sarcoma
Keywords: AIDS-related Kaposi sarcoma
recurrent Kaposi sarcoma
Lead sponsor: AIDS Malignancy Consortium
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: The Emmes Company, LLC
First posted: 2007-01-29
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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.

Eligibility 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

Primary outcomes:
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:
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
measure: Effect of treatment on KSHV viral load in plasma
timeFrame: 24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center - Miami
state: Florida
city: Cerqueira Cesar - Sao Paulo/SP
country: Brazil
facility: Instituto De Infectologia Emilio Ribas Hospital
city: Sao Paulo
country: Brazil
facility: Centro de Referencia e Tratamento DST/AIDS
Study officials:
affiliation: University of Miami Sylvester Comprehensive Cancer Center
name: Juan Carlos Ramos, MD
role: STUDY_CHAIR
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Dirk Dittmer, PhD
role: STUDY_CHAIR
affiliation: Instituto De Infectologia Emilio Ribas Hospital
name: Tamara Newman Lobato Souza
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto De Infectologia Emilio Ribas Hospital
name: Luis Carlos Pereira, MD
role: PRINCIPAL_INVESTIGATOR
References: