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Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma
This study has been terminated.
(Terminated due to slow accrual.)
Sponsor:
AIDS Malignancy Consortium
Collaborators:
National Cancer Institute (NCI)
The EMMES Corporation
Information provided by (Responsible Party):
AIDS Malignancy Consortium
ClinicalTrials.gov Identifier:
NCT00427414
First received: January 25, 2007
Last updated: April 28, 2015
Last verified: April 2015
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Sarcoma | Drug: liposomal daunorubicin citrate | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines |
Resource links provided by NLM:
Drug Information available for:
Sodium citrate
Citric acid monohydrate
Daunorubicin
Daunorubicin hydrochloride
Daunorubicin citrate
U.S. FDA Resources
Further study details as provided by AIDS Malignancy Consortium:
Primary Outcome Measures:
- Effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors [ Time Frame: 24-48 hours after the first treatment ]
Secondary Outcome Measures:
- Effect of treatment on KSHV viral gene expression in peripheral blood mononuclear cells [ Time Frame: 24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3 ]
- Effect of treatment on KSHV viral load in plasma [ Time Frame: 24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3 ]
| Enrollment: | 14 |
| Study Start Date: | September 2008 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: liposomal daunorubicin citrate
40 mg/m2 Days 1 and 15 every 28 days x 3 cycles
|
Drug: liposomal daunorubicin citrate
40 mg/m2 Days 1 and 15 every 28 days x 3 cycles
Other Name: DaunoXome
|
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427414
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427414
Locations
| United States, Florida | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | |
| Miami, Florida, United States, 33136 | |
| Brazil | |
| Instituto De Infectologia Emilio Ribas Hospital | |
| Cerqueira Cesar - Sao Paulo/SP, Brazil, 01246-900 | |
| Centro de Referencia e Tratamento DST/AIDS | |
| Sao Paulo, Brazil, 04121000 | |
Sponsors and Collaborators
AIDS Malignancy Consortium
National Cancer Institute (NCI)
The EMMES Corporation
Investigators
| Study Chair: | Juan Carlos Ramos, MD | University of Miami Sylvester Comprehensive Cancer Center |
| Study Chair: | Dirk Dittmer, PhD | UNC Lineberger Comprehensive Cancer Center |
| Principal Investigator: | Tamara Newman Lobato Souza | Instituto De Infectologia Emilio Ribas Hospital |
| Principal Investigator: | Luis Carlos Pereira, MD | Instituto De Infectologia Emilio Ribas Hospital |
More Information
| Responsible Party: | AIDS Malignancy Consortium |
| ClinicalTrials.gov Identifier: | NCT00427414 History of Changes |
| Other Study ID Numbers: |
AMC-050 U01CA070019 ( US NIH Grant/Contract Award Number ) CDR0000526564 ( Other Identifier: NCI ) |
| Study First Received: | January 25, 2007 |
| Last Updated: | April 28, 2015 |
Keywords provided by AIDS Malignancy Consortium:
|
AIDS-related Kaposi sarcoma recurrent Kaposi sarcoma |
Additional relevant MeSH terms:
|
Sarcoma Sarcoma, Kaposi Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections Virus Diseases Neoplasms, Vascular Tissue Daunorubicin Citric Acid |
Antibiotics, Antineoplastic Antineoplastic Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants Calcium Chelating Agents Chelating Agents Sequestering Agents |
ClinicalTrials.gov processed this record on June 23, 2017