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

Phase 2
18 Years
Not Enrolling
AIDS-related Kaposi Sarcoma, Classic Kaposi Sarcoma

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Trial Information

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


I. 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.


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.

Inclusion Criteria:

- 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

- 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

- 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

Exclusion Criteria:

- Pregnant or nursing

- Baseline diarrhea >= grade 2 by CTCAE

- Uncontrolled intercurrent illness including, but not limited to, any of the

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

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.

Outcome Time Frame:

Up to 11 months

Safety Issue:


Principal Investigator

Scot Remick

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Western Reserve University


United States: Food and Drug Administration

Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • AIDS-related Kaposi Sarcoma
  • Classic Kaposi Sarcoma
  • Treatment Experienced
  • Sarcoma, Kaposi
  • AIDS-Related Opportunistic Infections
  • Sarcoma



Case Western Reserve University Cleveland, Ohio  44106