NCT00521092

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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 27, 2007

Completed
1.4 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Last Updated

May 5, 2014

Status Verified

December 1, 2012

Enrollment Period

1.7 years

First QC Date

August 24, 2007

Last Update Submit

May 2, 2014

Conditions

AIDS-related Kaposi SarcomaClassic Kaposi Sarcoma

Keywords

Treatment Experienced

Outcome Measures

Primary Outcomes (4)

  • 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.

    Up to 11 months

  • Overall survival

    Will be estimated by Kaplan-Meier method.

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

  • Progression-free survival

    Will be estimated by Kaplan-Meier method.

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

  • 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.

    Up to 11 months

Secondary Outcomes (1)

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

    Baseline and 6 weeks

Study Arms (1)

Arm I

EXPERIMENTAL

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 malateProcedure: laboratory biomarker analysisProcedure: pharmacological study

Interventions

sunitinib malateDRUG

Given orally

Also known as: SU11248, sunitinib, Sutent
Arm I
laboratory biomarker analysisPROCEDURE

Correlative study

Arm I
pharmacological studyPROCEDURE

Correlative study

Also known as: pharmacological studies
Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +6 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AIDS-related Kaposi sarcoma

Interventions

Sunitinib

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Scot Remick

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2007

First Posted

August 27, 2007

Study Start

January 1, 2009

Primary Completion

October 1, 2010

Last Updated

May 5, 2014

Record last verified: 2012-12