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Cilengitide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Lung Cancer (CIRAB)

Primary Purpose

Brain and Central Nervous System Tumors, Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
cilengitide
pharmacological study
radiation therapy
Sponsored by
Universitätsmedizin Mannheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult tumors metastatic to brain, extensive stage small cell lung cancer, stage IV non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
  • No history of acute or chronic renal disease
  • No other malignancies treated within the past 5 years, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin
  • No uncontrolled hypertension
  • No history of coagulation disorder associated with bleeding or recurrent thrombotic events
  • No peptic ulcer disease within the past 6 months
  • No congestive heart failure, high risk for uncontrolled arrhythmia, or history of clinically significant coronary heart disease
  • No known alcohol or drug abuse
  • No other significant or acute concomitant disease
  • No dementia or altered mental status

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Concurrent corticosteroids allowed if the dosing regimen has ben stable ≥ 5 days
  • Concurrent anticonvulsants allowed if the dosing regimen has been stable for the past week
  • More than 30 days since prior participation in another clinical trial
  • No concurrent anticoagulation with vitamin K antagonists, therapeutic-dose anticoagulation with heparin resulting in prolonged PTT, or therapeutic-dose anticoagulation with low molecular weight heparin (low-dose [i.e. prophylactic], low molecular weight heparins allowed)
  • No prior whole-brain radiation or radiosurgery
  • No prior antiangiogenic therapy
  • No other concurrent anticancer therapy

Sites / Locations

  • University Medical Center, Department of SurgeryRecruiting

Outcomes

Primary Outcome Measures

Dose-limiting toxicity
Maximum-tolerated dose

Secondary Outcome Measures

Overall response rate
Overall survival
Brain-specific progression-free survival (PFS)
Tumor-specific PFS
Changes in functional MRI imaging studies at 6 and 12 weeks
Evidence of early response by functional MRI on days 1, 4, and 12
Changes of neurological and neurocognitive function tests at 6 and 12 weeks
Safety and toxicity of the combination of cilengitide and whole-brain radiation therapy
Pharmacokinetics of cilengitide

Full Information

First Posted
April 18, 2009
Last Updated
April 27, 2010
Sponsor
Universitätsmedizin Mannheim
Collaborators
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT00884598
Brief Title
Cilengitide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Lung Cancer
Acronym
CIRAB
Official Title
Cilengitide (EMD121974) in Combination With Whole Brain Radiotherapy in Patients With Brain Metastases From Lung Cancer - a Single-center, Open-label Phase I Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Universitätsmedizin Mannheim
Collaborators
Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
OBJECTIVES: Primary To assess the safety and tolerability of daily cilengitide by determining its dose-limiting toxicity and maximum-tolerated dose when combined with concomitant fractionated whole-brain radiation therapy in patients with brain metastases from lung cancer. Secondary To collect evidence of the best overall response rate, overall survival, brain-specific progression-free survival, and tumor-specific progression-free survival of these patients. To collect evidence of changes in functional MRI imaging studies at 6 and 12 weeks after initiation of therapy. To collect evidence of early response by functional MRI (ASL technique) on days 1, 4, and 12, immediately before and after the administration of cilengitide. To collect evidence of changes in neurological and neurocognitive function tests at 6 and 12 weeks after initiation of therapy. To further evaluate the safety and toxicity of the combination of cilengitide and whole-brain radiation therapy. To further evaluate the pharmacokinetics of cilengitide administered daily. OUTLINE: Patients receive oral cilengitide once daily and undergo whole-brain radiotherapy on the same days. Treatment continues for 2 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection on days 1, 4, 5, and 12 for pharmacokinetic studies. After completion of study treatment, patients are followed for 10 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Lung Cancer
Keywords
adult tumors metastatic to brain, extensive stage small cell lung cancer, stage IV non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cilengitide
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Dose-limiting toxicity
Title
Maximum-tolerated dose
Secondary Outcome Measure Information:
Title
Overall response rate
Title
Overall survival
Title
Brain-specific progression-free survival (PFS)
Title
Tumor-specific PFS
Title
Changes in functional MRI imaging studies at 6 and 12 weeks
Title
Evidence of early response by functional MRI on days 1, 4, and 12
Title
Changes of neurological and neurocognitive function tests at 6 and 12 weeks
Title
Safety and toxicity of the combination of cilengitide and whole-brain radiation therapy
Title
Pharmacokinetics of cilengitide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 No history of acute or chronic renal disease No other malignancies treated within the past 5 years, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin No uncontrolled hypertension No history of coagulation disorder associated with bleeding or recurrent thrombotic events No peptic ulcer disease within the past 6 months No congestive heart failure, high risk for uncontrolled arrhythmia, or history of clinically significant coronary heart disease No known alcohol or drug abuse No other significant or acute concomitant disease No dementia or altered mental status PRIOR CONCURRENT THERAPY: See Disease Characteristics Concurrent corticosteroids allowed if the dosing regimen has ben stable ≥ 5 days Concurrent anticonvulsants allowed if the dosing regimen has been stable for the past week More than 30 days since prior participation in another clinical trial No concurrent anticoagulation with vitamin K antagonists, therapeutic-dose anticoagulation with heparin resulting in prolonged PTT, or therapeutic-dose anticoagulation with low molecular weight heparin (low-dose [i.e. prophylactic], low molecular weight heparins allowed) No prior whole-brain radiation or radiosurgery No prior antiangiogenic therapy No other concurrent anticancer therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Manegold, MD
Organizational Affiliation
University Medical Center Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center, Department of Surgery
City
Mannheim
ZIP/Postal Code
D-68167
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Manegold, MD
Phone
49-621-383-2199
Email
prof.manegold@t-online.de

12. IPD Sharing Statement

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Cilengitide and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases From Lung Cancer

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