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Brain and Central Nervous System TumorsPhase 1CIRABNCT00884598

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

A Phase 1 study testing cilengitide, pharmacological study and radiation therapy in people with Brain and Central Nervous System Tumors and Lung Cancer, run by Universitätsmedizin Mannheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cilengitide, pharmacological study and radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteGermany
Study dates
Dec 2008to Oct 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 33Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • University Medical Center, Department of Surgery

    Mannheim, D-68167

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
cilengitide, pharmacological study, radiation therapy
Keywords
adult tumors metastatic to brain, extensive stage small cell lung cancer, stage IV non-small cell lung cancer
Medical subject headings
Central Nervous System Neoplasms, Lung Neoplasms, Brain Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00884598
Study groupRoleWhat they receive
CilengitideExperimentalNot described
Receives: Drug: cilengitide; Other: pharmacological study; Radiation: radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 days

  2. 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

    Measured: 12 days

Secondary outcomes (19)

  1. Overall response rate

    Any response to treatment

    Measured: 12 weeks

  2. Overall survival

    Death as event, Kaplan-Meier (KM)

    Measured: 1 year

  3. Brain-specific progression-free survival (PFS)

    Every recurrence within the brain or death is an event, Kaplan-Meier (KM)

    Measured: 1 year

  4. Tumor-specific PFS

    Every tumor related event or death will be counted, Kaplan-Meier (KM)

    Measured: 1 year

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

    time-to-peak measurements

    Measured: 12 weeks

  6. Changes in functional MRI imaging (blood flow) at 6 and 12 weeks

    blood flow measurements

    Measured: 12 weeks

  7. Changes in functional MRI imaging (blood volume changes) at 6 and 12 weeks

    blood volume changes during functional MRI

    Measured: 12 weeks

  8. Evidence of early response by functional MRI on days 1, 4, and 12

    (ASL technique) on day 1,4 and 12, immediately before and after the administration of cilengitide.

    Measured: 12 days

  9. Changes of neurocognitive function tests (intelligence) at 6 and 12 weeks

    Intelligence was measured with a multiple-choice test of vocabulary knowledge.

    Measured: 12 weeks

  10. Changes of neurocognitive function tests (memory figures) at 6 and 12 weeks

    Memory was tested by aims of "Medical College of Georgia Complex Figures"

    Measured: 12 weeks

  11. Changes of neurocognitive function tests (memory verbal) at 6 and 12 weeks

    Memory was tested by aims of "Rea Auditory Verbal Learning Test - German Version"

    Measured: 12 weeks

  12. Changes of neurocognitive function tests (perception) at 6 and 12 weeks

    Perception was assessed by the "Digit Symbol Substitution Test"

    Measured: 12 weeks

  13. Changes of neurocognitive function tests (attention/alertness) at 6 and 12 weeks

    Attention was tested by "Alertness"

    Measured: 12 weeks

  14. Changes of neurocognitive function tests (attention) at 6 and 12 weeks

    Attention was tested by "Divided Attention"

    Measured: 12 weeks

  15. Changes of neurocognitive function tests (attention speaking) at 6 and 12 weeks

    Attention was tested by "Go,A.lo-Go".

    Measured: 12 weeks

  16. Fatigue at 6 and 12 weeks

    "Functional Assessment of Cancer Therapy - Fatigue Subscale" measured in points (range 0-52)

    Measured: 12 weeks

  17. Anxiety/depression at 6 and 12 weeks

    "Hospital Anxiety and Depression Scale - German Version"

    Measured: 12 weeks

  18. Activities of daily living (Barthel) at 6 and 12 weeks

    "Barthel Activities of Daily Living Index" measured in points (range 0-100)

    Measured: 12 weeks

  19. Activities of daily living (instrumental) at 6 and 12 weeks

    "lnstrumental Activities of Daily Living Scale" measured in points (range 0-8)

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionOct 2012
  4. Study completionOct 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00884598
Sponsor's protocol ID
CDR0000636508
Other IDs
HUMCM-CIRAB, EUDRACT-2008-004573-17
Acronym
CIRAB
Status last verified
May 2024
First submitted
18 Apr 2009
Last updated
10 May 2024
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing cilengitide, pharmacological study and radiation therapy in people with Brain and Central Nervous System Tumors and Lung Cancer, run by Universitätsmedizin Mannheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (time frame: 12 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00884598.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.

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