SarcomaPhase 1NCT00427414
Liposomal Daunorubicin in Treating Patients With HIV-Related Kaposi's Sarcoma
A Phase 1 study testing liposomal daunorubicin citrate in people with Sarcoma, run by AIDS Malignancy Consortium at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma
- What is being tested?
- liposomal daunorubicin citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Sep 2008to Nov 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Brazil2 sites
Instituto De Infectologia Emilio Ribas Hospital
Cerqueira Cesar - Sao Paulo/SP, 01246-900
Centro de Referencia e Tratamento DST/AIDS
São Paulo, São Paulo, 04121000
United States1 site
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, 33136
About this study
Official title: Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines
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.
Read the 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.
- Conditions
- Sarcoma
- Being tested
- liposomal daunorubicin citrate
- Keywords
- AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma
- Medical subject headings
- Sarcoma, AIDS-related Kaposi sarcoma, Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liposomal daunorubicin citrateDrug
Also called DaunoXome
40 mg/m2 Days 1 and 15 every 28 days x 3 cycles
| Study group | Role | What they receive |
|---|---|---|
| liposomal daunorubicin citrate | Experimental | 40 mg/m2 Days 1 and 15 every 28 days x 3 cycles Receives: Drug: liposomal daunorubicin citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of liposomal daunorubicin citrate on Kaposi's sarcoma-associated herpes virus (KSHV) viral gene expression in tumors
Measured: 24-48 hours after the first treatment
Secondary outcomes (2)
Effect of treatment on KSHV viral gene expression in peripheral blood mononuclear cells
Measured: 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
Measured: 24-48 hours after treatment on Day 1/cycle 1, Day 8/cycle 1, and Day 29/cycle 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startSep 2008
- Primary completionNov 2010
- Study completionNov 2011
Why it stopped: Terminated due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC
- Responsible party
- Sponsor
- Investigators
- Juan Carlos Ramos, MD, Study chair, University of Miami Sylvester Comprehensive Cancer CenterDirk Dittmer, PhD, Study chair, UNC Lineberger Comprehensive Cancer CenterTamara Newman Lobato Souza, Principal investigator, Instituto De Infectologia Emilio Ribas HospitalLuis Carlos Pereira, MD, Principal investigator, Instituto De Infectologia Emilio Ribas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427414
- Sponsor's protocol ID
- AMC-050
- Other IDs
- U01CA070019, CDR0000526564
- Status last verified
- Apr 2015
- First submitted
- 25 Jan 2007
- Last updated
- 29 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Viral Load and Transcription in Kaposi's Sarcoma Patients Treated With Liposomal Anthracyclines
- ClinicalTrials.gov ID
- NCT00427414
- Acronym / sponsor ID
- AMC-050
- Conditions
- Sarcoma
- Keywords
- AIDS-related Kaposi sarcoma, recurrent Kaposi sarcoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to slow accrual.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI), The Emmes Company, LLC
- Study start
- Sep 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liposomal daunorubicin citrate | Experimental | Drug: liposomal daunorubicin citrate40 mg/m2 Days 1 and 15 every 28 days x 3 cycles |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liposomal daunorubicin citrateAlso: DaunoXome40 mg/m2 Days 1 and 15 every 28 days x 3 cycles | Drug | liposomal daunorubicin citrate |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Terminated due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Carlos Ramos, MD study chair
University of Miami Sylvester Comprehensive Cancer Center
Dirk Dittmer, PhD study chair
UNC Lineberger Comprehensive Cancer Center
Tamara Newman Lobato Souza principal investigator
Instituto De Infectologia Emilio Ribas Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing liposomal daunorubicin citrate in people with Sarcoma, run by AIDS Malignancy Consortium at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Brazil, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated due to slow accrual.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2015.