Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00521092
Recruitment Status : Withdrawn (No participants enrolled.)
First Posted : August 27, 2007
Last Update Posted : May 5, 2014
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Brief 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.

Condition or disease Intervention/treatment Phase
AIDS-related Kaposi Sarcoma Classic Kaposi Sarcoma Drug: sunitinib malate Procedure: laboratory biomarker analysis Procedure: pharmacological study Phase 2

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib (SU11248) in Patients With Kaposi's Sarcoma in East Africa
Study Start Date : January 2009
Actual Primary Completion Date : October 2010

Arm Intervention/treatment
Experimental: Arm I
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.
Drug: sunitinib malate
Given orally
Other Names:
  • SU11248
  • sunitinib
  • Sutent

Procedure: laboratory biomarker analysis
Correlative study

Procedure: pharmacological study
Correlative study
Other Name: pharmacological studies

Primary Outcome Measures :
  1. Response rate [ Time Frame: Up to 11 months ]
    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.

  2. Overall survival [ Time Frame: From the date of treatment to date of death, assessed up to 11 months ]
    Will be estimated by Kaplan-Meier method.

  3. Progression-free survival [ Time Frame: From the date of treatment to date of death or date of disease progression, assessed up to 11 months ]
    Will be estimated by Kaplan-Meier method.

  4. Levels of plasma-associated HIV-1 RNA viral load and cell-associated KSHV DNA viral load [ Time Frame: Up to 11 months ]
    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.

Secondary Outcome Measures :
  1. Changes in CD4+ and CD8+ cell counts, levels of plasma-associated HIV-1 RNA, and cell-associated KSHV DNA load [ Time Frame: Baseline and 6 weeks ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00521092

Sponsors and Collaborators
National Cancer Institute (NCI)
National Institute of Allergy and Infectious Diseases (NIAID)
Principal Investigator: Scot Remick Case Comprehensive Cancer Center

Responsible Party: National Cancer Institute (NCI) Identifier: NCT00521092     History of Changes
Other Study ID Numbers: NCI-2009-00229
NCI-2009-00229 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 1706 - AMC 049
CASE 1706 / AMC 049 ( Other Identifier: Case Comprehensive Cancer Center )
7831 ( Other Identifier: CTEP )
U01CA062502 ( U.S. NIH Grant/Contract )
P30AI036219 ( U.S. NIH Grant/Contract )
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: May 5, 2014
Last Verified: December 2012

Keywords provided by National Cancer Institute (NCI):
Treatment Experienced

Additional relevant MeSH terms:
Sarcoma, Kaposi
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Vascular Tissue
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors