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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA070019 | U.S. NIH Grant/Contract | View source | |
| CDR0000526564 | Other Identifier | NCI |
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Terminated due to slow accrual.
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| The Emmes Company, LLC | INDUSTRY |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| liposomal daunorubicin citrate | Experimental | 40 mg/m2 Days 1 and 15 every 28 days x 3 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liposomal daunorubicin citrate | Drug | 40 mg/m2 Days 1 and 15 every 28 days x 3 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors | 24-48 hours after the first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of treatment on KSHV viral gene expression in peripheral blood mononuclear cells | 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 | 24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3 |
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DISEASE CHARACTERISTICS:
Histologically confirmed Kaposi's sarcoma (KS) involving the following:
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
PATIENT CHARACTERISTICS:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Juan Carlos Ramos, MD | University of Miami Sylvester Comprehensive Cancer Center | Study Chair |
| Dirk Dittmer, PhD | UNC Lineberger Comprehensive Cancer Center | Study Chair |
| Tamara Newman Lobato Souza | Instituto De Infectologia Emilio Ribas Hospital | Principal Investigator |
| Luis Carlos Pereira, MD | Instituto De Infectologia Emilio Ribas Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Sylvester Comprehensive Cancer Center - Miami | Miami | Florida | 33136 | United States | ||
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| C554498 | AIDS-related Kaposi sarcoma |
| D012514 | Sarcoma, Kaposi |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006566 | Herpesviridae Infections |
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| ID | Term |
|---|---|
| D003630 | Daunorubicin |
| ID | Term |
|---|---|
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Centro de Referencia e Tratamento DST/AIDS |
| São Paulo |
| São Paulo |
| 04121000 |
| Brazil |
| Instituto De Infectologia Emilio Ribas Hospital | Cerqueira Cesar - Sao Paulo/SP | 01246-900 | Brazil |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D009383 | Neoplasms, Vascular Tissue |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |