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Sunitinib Malate in Treating East African Patients With Kaposi Sarcoma
This study is not yet open for participant recruitment.
Verified by National Cancer Institute (NCI), August 2007
Sponsors and Collaborators: Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00521092
  Purpose

RATIONALE: 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.

PURPOSE: This phase II trial is studying the side effects and how well sunitinib malate works in treating patients with Kaposi sarcoma.


Condition Intervention Phase
Sarcoma
Drug: sunitinib malate
Procedure: laboratory biomarker analysis
Procedure: pharmacological study
Phase II

MedlinePlus related topics: Cancer Kaposi's Sarcoma Soft Tissue Sarcoma
Drug Information available for: Sunitinib Sunitinib malate Malic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Sunitinib (SU11248) in Patients With Kaposi's Sarcoma in East Africa

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate in endemic Kaposi sarcoma (KS), epidemic (AIDS) KS, and in all patients [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Disease progression-free survival [ Designated as safety issue: No ]
  • Levels of plasma-associated HIV-1 RNA viral load and cell-associated KSHV DNA viral load [ Designated as safety issue: No ]
  • Morphological changes in KS lesions [ Designated as safety issue: No ]
  • Pharmacokinetic profile of sunitinib malate [ Designated as safety issue: No ]
  • KSHV gene expression in endemic and epidemic KS lesions in patients in Uganda and Kenya [ Designated as safety issue: No ]

Estimated Enrollment: 31
Study Start Date: October 2006
Estimated Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the clinical response of sunitinib malate in patients with Kaposi sarcoma (KS) in Uganda and Kenya.
  • Compare clinical response rates in endemic versus epidemic (AIDS) KS.
  • Determine the safety and tolerability of sunitinib malate in patients with endemic or epidemic (AIDS) KS.

Secondary

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed Kaposi sarcoma
  • Documented HIV-serostatus

    • HIV-seronegative (endemic KS)
    • 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)
  • Patient resides in Uganda or Kenya, East Africa

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • ECOG performance status 0-1
  • Life expectancy ≥ 24 weeks
  • Absolute granulocyte count > 1,000/μL
  • Platelet count > 75,000/μL
  • Hemoglobin > 8.0 g/dL OR hematocrit > 24%
  • Serum creatinine ≤ 2.0 mg/dL
  • Total bilirubin ≤ 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

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
    • Cardiac arrhythmia (i.e., history of serious ventricular arrhythmia, ventricular fibrillation, or ventricular tachycardia ≥ 3 beats in a row OR QTc ≥ 500 msec)
    • Psychiatric illness or social situation that would limit compliance with study requirements

PRIOR CONCURRENT THERAPY:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00521092

Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Study Chair: Scot C. Remick, MD Case Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000561751, CASE-1706, AMC-049
Study First Received: August 24, 2007
Last Updated: October 22, 2008
ClinicalTrials.gov Identifier: NCT00521092  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
AIDS-related Kaposi sarcoma
classic Kaposi sarcoma
Treatment Experienced

Study placed in the following topic categories:
Virus Diseases
Neoplasms, Connective and Soft Tissue
Kaposi sarcoma
Sunitinib
Malignant mesenchymal tumor
Sarcoma, Kaposi
Sarcoma
DNA Virus Infections
Soft tissue sarcomas
Herpesviridae Infections

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Vascular Tissue
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009