NCT00884598

Brief Summary

RATIONALE: Cilengitide may stop the growth of brain metastases by blocking blood flow to the tumor. Radiation therapy uses high energy X-rays to kill tumor cells. Giving cilengitide together with radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cilengitide when given together with whole-brain radiation therapy in treating patients with brain metastases from lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

3.8 years

First QC Date

April 18, 2009

Last Update Submit

May 7, 2024

Conditions

Brain and Central Nervous System TumorsLung Cancer

Keywords

adult tumors metastatic to brainextensive stage small cell lung cancerstage IV non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

  • Dose-limiting toxicity

    (i) Any grade III-IV non-hematological toxicity as defined by CTCAE, version 3.0, with the exclusion ofalopecia, nausea, vomiting, and fever that can be rapidly contolled with appropriate measures; (ii) absolute neutrophil count (ANC)\<0.5x10'/L lasting for \>7days; (iii) febrile neutropenia defined as ANC \<1.0x10'/L and fever \>38.5°C; (iv) platelets \<25x10'/L or thrombocytopenic bleeding requiring transfusion; and (v) severe hypotension requiring dopamine administration.

    12 days

  • Maximum-tolerated dose

    5 planned steps to be tested: 100, 250, 500, 750, to 1000mg; the highest dose at which one or no DLT will have been observed among 6 patients

    12 days

Secondary Outcomes (19)

  • Overall response rate

    12 weeks

  • Overall survival

    1 year

  • Brain-specific progression-free survival (PFS)

    1 year

  • Tumor-specific PFS

    1 year

  • Changes in functional MRI imaging (time to peak) at 6 and 12 weeks

    12 weeks

  • +14 more secondary outcomes

Study Arms (1)

Cilengitide

EXPERIMENTAL
Drug: cilengitideOther: pharmacological studyRadiation: radiation therapy

Interventions

cilengitideDRUG
Cilengitide
pharmacological studyOTHER
Cilengitide
radiation therapyRADIATION
Cilengitide

Eligibility Criteria

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

You may qualify if:

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed lung cancer (small cell or non-small cell lung cancer)
  • Patient must be eligible for whole-brain radiotherapy
  • Presence of brain metastasis (single or multiple, synchronous or metachronous) from lung cancer not amenable to surgery or radiosurgery (presence of metastases at any other site is allowed)
  • No leptomeningeal metastasis or known subarachnoid spread of tumor
  • PATIENT CHARACTERISTICS:
  • ECOG performance status (PS) 0-1 (ECOG PS 2 allowed if due to the presence of cerebral metastases and not due to a high peripheral-tumor load or other reasons)
  • Life expectancy ≥ 3 months
  • Adequate hematologic function
  • Total bilirubin \< 1.5 times upper limit of normal (ULN)
  • AST, ALT, and alkaline phosphatase \< 2.5 times ULN
  • Creatinine clearance \> 60 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after completion of study treatment
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center, Department of Surgery

Mannheim, D-68167, Germany

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsLung NeoplasmsBrain NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CilengitideRadiotherapy

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesBrain DiseasesCentral Nervous System DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Christian Manegold, MD

    University Medical Center Mannheim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Christian Manegold

Study Record Dates

First Submitted

April 18, 2009

First Posted

April 21, 2009

Study Start

December 1, 2008

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

May 10, 2024

Record last verified: 2024-05

Locations

DE(1)