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AIDS-related Kaposi SarcomaPhase 2NCT00521092

Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma

A Phase 2 study testing sunitinib malate, laboratory biomarker analysis and pharmacological study in people with AIDS-related Kaposi Sarcoma and Classic Kaposi Sarcoma, run by National Cancer Institute (NCI).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying the side effects and how well sunitinib malate works in treating patients with Kaposi sarcoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sunitinib malate, laboratory biomarker analysis and pharmacological study
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2009to Oct 2010
Phase
Phase 2
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

Who may be able to join

  • ECOG performance status 0-1
  • Documented HIV-serostatus [HIV-seronegative (endemic KS) or HIV-seropositive (epidemic/AIDS KS)]
  • No symptomatic organ involvement, visceral crisis, or life-threatening disease (e.g., extensive or symptomatic pulmonary disease or reticuloendothelial system/hepatic involvement) for which aggressive double- or triple-drug combination chemotherapy for urgent cytoreduction is indicated (i.e., doxorubicin hydrochloride, bleomycin, and vinblastine [ABV], BV, or AV)
  • Histologically confirmed Kaposi sarcoma
  • Platelet count > 75,000/uL
  • Life expectancy >= 24 weeks
Show all 21Show fewer
  • Absolute granulocyte count > 1,000/uL
  • Hemoglobin > 8.0 g/dL OR hematocrit > 24%
  • Serum creatinine =< 2.0 mg/dL
  • AST < 3 times normal
  • Fertile patients must use effective contraception
  • Normal clinical cardiac examination and normotensive (systolic and diastolic BP < 140/90 mm Hg) documented on at least two occasions prior to enrollment
  • Normal ECG including QTc interval < 500 msec
  • Normal echocardiogram prior to enrollment (if feasibly possible)
  • Must be able to swallow study medication
  • No acute infections [Patients with chronic infections (e.g., malaria, tuberculosis, parasitic infections, or hepatitis B or C) that may be active but under treatment are allowed provided all eligibility criteria are met]
  • At least 60 days since prior local treatment modalities (e.g., resection, cryosurgery, radiotherapy, or intralesional therapy) AND treated lesions must have clearly progressed following such therapies if the lesions are to be used as an index lesion
  • No prior systemic anticancer therapy for Kaposi sarcoma
  • Concurrent antiretroviral therapy required for HIV-seropositive patients (Patient must be on a stable regimen 8 weeks prior to study enrollment--An exception may be made for patients who have exhausted or are intolerant to all available regimens)
  • No other concurrent systemic anticancer therapy
  • Patient resides in Uganda or Kenya, East Africa

Who cannot join

  • Pregnant or nursing
  • Baseline diarrhea >= grade 2 by CTCAE
  • Uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Ongoing or acute active infection
  • Symptomatic congestive heart failure (NYHA class III or IV heart disease)
  • Unstable angina pectoris
  • Uncontrolled intercurrent illness including, but not limited to, any of the following: 1) Cardiac arrhythmia (i.e., history of serious ventricular arrhythmia, ventricular fibrillation, or ventricular tachycardia >= 3 beats in a row OR QTc >= 500 msec) 2) Psychiatric illness or social situation that would limit compliance with study requirements

About this study

Official title: Phase II Study of Sunitinib (SU11248) in Patients With Kaposi's Sarcoma in East Africa

Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying the side effects and how well sunitinib malate works in treating patients with Kaposi sarcoma.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the clinical response of sunitinib malate in patients with Kaposi sarcoma (KS) in Uganda and Kenya.

II. Compare clinical response rates in endemic versus epidemic (AIDS) KS. III. Determine the safety and tolerability of sunitinib malate in patients with endemic or epidemic (AIDS) KS.

SECONDARY OBJECTIVES:

I Monitor the impact of sunitinib malate on underlying HIV-1 and Kaposi sarcoma-associated herpesvirus (KSHV) viral infection (HIV-1 plasma RNA and KSHV cell-associated DNA).

II. Evaluate morphological changes in KS lesions after treatment. III. Determine the pharmacokinetic profile of sunitinib malate in patients with KS.

IV Evaluate KSHV gene expression in endemic and epidemic KS lesions in patients in Uganda and Kenya.

OUTLINE: This is a multicenter study. Patients are stratified according to HIV-serostatus (endemic [HIV-seronegative] vs epidemic [HIV-seropositive/AIDS] kaposi sarcoma).

Patients receive oral sunitinib malate 50 mg once daily for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue and blood sample collection periodically for correlative and pharmacokinetic studies. Samples are analyzed for CD4 lymphocyte counts, HIV-1 plasma RNA levels, KSHV specific antibodies, expression pattern of KSHV in vitro and in vivo, expression of latently versus lytically expressed genes in tumor tissue, and plasma concentrations of sunitinib malate and its active metabolite, SU12662.

After completion of study treatment, patients are followed every 6 weeks.

Being tested
sunitinib malate, laboratory biomarker analysis, pharmacological study
Keywords
Treatment Experienced
Medical subject headings
AIDS-related Kaposi sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sunitinib malateDrug

    Also called SU11248, sunitinib, Sutent

    Given orally

  • laboratory biomarker analysisProcedure or surgery

    Correlative study

  • pharmacological studyProcedure or surgery

    Also called pharmacological studies

    Correlative study

Study groups in NCT00521092
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral sunitinib malate 50 mg once daily for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
Receives: Drug: sunitinib malate; Procedure: laboratory biomarker analysis; Procedure: pharmacological study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    The true response rate will be estimated based on the number of responses using a binomial distribution. The confidence intervals for them can be estimated using same distribution. Chi-square test or Fisher's exact test will be used to examine the difference of response rate between the two cohorts and log-rank test for the difference of survival outcomes.

    Measured: Up to 11 months

  2. Overall survival

    Will be estimated by Kaplan-Meier method.

    Measured: From the date of treatment to date of death, assessed up to 11 months

  3. Progression-free survival

    Will be estimated by Kaplan-Meier method.

    Measured: From the date of treatment to date of death or date of disease progression, assessed up to 11 months

  4. Levels of plasma-associated HIV-1 RNA viral load and cell-associated KSHV DNA viral load

    Multivariate analysis will be performed using the Cox proportional hazards model. The effects of CD4+ lymphocyte counts, plasma HIV-1 RNA viral load and KSHV DNA level on the objective response rate will be evaluated using multivariate logistic regression.

    Measured: Up to 11 months

Secondary outcomes (1)

  1. Changes in CD4+ and CD8+ cell counts, levels of plasma-associated HIV-1 RNA, and cell-associated KSHV DNA load

    For each treatment cohort and for all groups combined, the Wilcoxon signed rank test (the non-parametric version of paired T-test) will be used to evaluate the changes.

    Measured: Baseline and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2007 (estimated)
  2. Study startJan 2009
  3. Primary completionOct 2010

Why it stopped: No participants enrolled.

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00521092
Sponsor's protocol ID
NCI-2009-00229
Other IDs
NCI-2009-00229, CASE 1706 - AMC 049, CDR0000561751, CASE 1706 / AMC 049, 7831, U01CA062502, P30AI036219
Status last verified
Dec 2012
First submitted
24 Aug 2007
Last updated
5 May 2014
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sunitinib malate, laboratory biomarker analysis and pharmacological study in people with AIDS-related Kaposi Sarcoma and Classic Kaposi Sarcoma, run by National Cancer Institute (NCI).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 7 exclusion criteria. 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: withdrawn, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 withdrawn before enrolling participants, so there are no results.

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?

Response rate (time frame: Up to 11 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00521092.

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 5 May 2014.

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