NCT01122888

Brief Summary

This clinical trial is studying how well giving cilengitide together with sunitinib malate works in treating patients with advanced solid tumors or glioblastoma multiforme. Cilengitide and sunitinib malate may stop the growth of tumor cells by blocking blood flow to the tumor. Giving cilengitide together with sunitinib malate may kill more tumor cells. Studying samples of blood in the laboratory from patients receiving cilengitide and sunitinib malate may help doctors understand the effect of these drugs on biomarkers.

Trial Health

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Trial Health Score

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

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2009

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

December 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 12, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 13, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

April 28, 2015

Status Verified

April 1, 2015

Enrollment Period

2.8 years

First QC Date

January 12, 2010

Last Update Submit

April 27, 2015

Conditions

Adult Giant Cell GlioblastomaAdult GlioblastomaAdult GliosarcomaAdult Solid NeoplasmRecurrent Adult Brain Neoplasm

Outcome Measures

Primary Outcomes (1)

  • Change in serum VEGFR2

    Over 14 days from the end of sunitinib to the end of course 1

Secondary Outcomes (5)

  • Comparison of the change in serum VEGFR2 in courses 1 and 2

    Over 14 days

  • Progression-free survival

    Assessed up to 30 days after completion of study treatment

  • Response rate evaluated using RECIST criteria

    Up to 30 days after completion of study treatment

  • Serum type I collagen c-telopeptide crosslink measurements

    Up to 30 days after completion of study treatment

  • Toxicity rates, graded using the NCI CTCAE version 4.0

    Up to 30 days after completion of study treatment

Study Arms (2)

Arm I (course 1)

EXPERIMENTAL

Patients receive cilengitide IV over 1 hour twice weekly for 2 weeks.

Drug: CilengitideOther: Laboratory Biomarker Analysis

Arm II (course 1)

OTHER

Patients do not receive treatment and undergo a 2-week rest period.

Other: Clinical ObservationOther: Laboratory Biomarker Analysis

Interventions

CilengitideDRUG

Given IV

Also known as: EMD 121974, EMD-121974
Arm I (course 1)
Clinical ObservationOTHER

Patients undergo a 2-week rest period

Arm II (course 1)
Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (course 1)Arm II (course 1)

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed solid tumor or malignant glioblastoma multiforme meeting \>= 1 of the following criteria:
  • Disease refractory to standard therapy
  • No standard therapy exists
  • Sunitinib malate monotherapy would be appropriate management
  • Measurable disease is not required
  • Previously treated brain metastases or primary brain neoplasms allowed provided patient is not receiving concurrent corticosteroids
  • Karnofsky performance status 70-100%
  • Absolute neutrophil count (ANC) \>= 1,500/μL
  • White blood cell count (WBC) \>= 3,000/μL
  • Platelet count \>= 100,000/μL
  • Hemoglobin \>= 9 g/dL
  • Total bilirubin normal (unless due to documented Gilbert syndrome)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 times upper limit of normal (ULN) (\< 5 times ULN in the presence of liver metastases)
  • Creatinine normal OR creatinine clearance \>= 60 mL/min
  • Serum calcium =\< 12.0 mg/dL
  • +56 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

GlioblastomaGliosarcomaBrain Neoplasms

Interventions

CilengitideWatchful Waiting

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Michael Maitland

    University of Chicago Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2010

First Posted

May 13, 2010

Study Start

December 1, 2009

Primary Completion

September 1, 2012

Study Completion

April 1, 2015

Last Updated

April 28, 2015

Record last verified: 2015-04

Locations

US(1)