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Brain and Central Nervous System TumorsPhase 1NCT00387933

Imatinib Mesylate, Vatalanib, and Hydroxyurea in Treating Patients With Recurrent or Relapsed Malignant Glioma

A Phase 1 study testing hydroxyurea, imatinib mesylate and vatalanib in people with Brain and Central Nervous System Tumors, run by Duke University at 1 site in United States.

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: Imatinib mesylate, vatalanib, and hydroxyurea may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vatalanib may also stop the growth of tumor cells by blocking blood flow to the tumor. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
hydroxyurea, imatinib mesylate and vatalanib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
Jul 2005to Jan 2009
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

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant glioma
  • Grade 3 or 4 disease
  • In first, second, or third recurrence or relapse
  • Multifocal disease allowed

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Life expectancy ≥ 12 weeks
  • Absolute neutrophil count > 1,500/mm^3
  • Hemoglobin > 9 g/dL
  • Platelet count > 100,000/mm^3
  • Potassium normal*
  • Total calcium (corrected) normal*
  • Magnesium normal*
  • Phosphorus normal*
  • aspartate transaminase (AST) and alanine transaminase (ALT) < 2.5 times upper limit of normal (ULN)
  • Bilirubin < 1.5 times ULN
  • Negative proteinuria by dipstick OR total urinary protein ≤ 500 mg with creatinine clearance ≥ 50 mL/min by 24-hour urine collection
  • Creatinine < 1.5 times ULN OR creatinine clearance > 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No acute or chronic liver or renal disease
  • left ventricular ejection fraction (LVEF) ≥ 45% by Multi Gated Acquisition Scan (MUGA) or echocardiogram
  • No complete left bundle branch block
  • No obligate use of a cardiac pacemaker
  • No congenital long QT syndrome
  • No history of or current ventricular or atrial tachyarrhythmias
  • No clinically significant resting bradycardia (i.e., heart rate < 50 beats/minute)
  • No right bundle branch block with left anterior hemiblock (bifascicular block)
  • No uncontrolled hypertension ≥ grade 2, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
  • No concurrent unstable angina pectoris or angina pectoris within the past 3 months
  • No congestive heart failure (CHF)
  • No history of CHF or arrhythmias requiring concurrent digoxin or verapamil
  • No acute myocardial infarction within the past 3 months
  • No other impaired cardiac function or clinically significant cardiac disease
  • No peripheral neuropathy ≥ grade 2
  • No unresolved diarrhea ≥ grade 2
  • No uncontrolled diabetes
  • No active or uncontrolled infection requiring intravenous antibiotics
  • No impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of vatalanib, hydroxyurea, and/or everolimus, including any of the following:
  • Ulcerative disease
  • Uncontrolled nausea, vomiting, or diarrhea
  • Malabsorption syndrome
  • Small bowel resection
  • No other concurrent severe and/or uncontrolled medical condition that would preclude study participation or compliance
  • No known HIV positivity
  • No other primary malignancy that is clinically significant or requires active intervention NOTE: *Supplement allowed

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • More than 2 weeks since prior tumor biopsy (4 weeks since prior surgical resection)
  • Prior polifeprosan 20 with carmustine implant (Gliadel® wafer) allowed at discretion of principal investigator
  • Prior hydroxyurea allowed
  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and 1 week for metronomic-dosed chemotherapy [e.g., daily etoposide hydrochloride or cyclophosphamide]) and recovered
  • More than 4 weeks since prior radiotherapy and recovered
  • More than 2 weeks since prior immunotherapy and recovered
  • More than 4 weeks since prior investigational drugs and recovered
  • No prior platelet-derived growth factor- or vascular endothelial growth factor-directed therapies
  • More than 2 weeks since prior hematopoietic colony-stimulating factor (e.g., filgrastim [G-CSF] or sargramostim [Granulocyte-macrophage colony-stimulating factor (GM-CSF)])
  • Prior epoetin alfa allowed
  • No concurrent warfarin

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: Phase I Dose Escalation of Gleevec in Combination With PTK787/ZK 222584 (PTK/ZK) Plus Hydroxyurea

RATIONALE: Imatinib mesylate, vatalanib, and hydroxyurea may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vatalanib may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving imatinib mesylate and vatalanib together with hydroxyurea may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of imatinib mesylate and vatalanib when given together with hydroxyurea in treating patients with recurrent or relapsed malignant glioma.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose and dose-limiting toxicity of imatinib mesylate and vatalanib when administered with hydroxyurea in patients with recurrent or relapsed grade 3 or 4 malignant glioma.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine the single-dose and repeated-dose pharmacokinetic profiles of imatinib mesylate (in serum) and vatalanib in these patients.
  • Determine the pre- and post-treatment antiangiogenic effects of this regimen in these patients, using dynamic contrast-enhanced MRI to evaluate changes in the extent of vascular permeability, perfusion, and relative tumor blood volume.
  • Determine whether changes in diffusion-weighted images MRI (quantitated by apparent diffusion coefficient maps) correlate with tumor cellularity and tumor cell death in patients treated with this regimen.
  • Determine antitumor activity of this regimen, in terms of radiographic response, progression-free survival, and overall survival, in these patients.

OUTLINE: This is an open-label, dose-escalation study of imatinib mesylate and vatalanib.

Patients receive oral vatalanib once daily, oral imatinib mesylate once daily, and oral hydroxyurea twice daily on days 1-28*. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients receive vatalanib alone daily on days 1-7 followed by vatalanib, imatinib mesylate, and hydroxyurea on days 8-35 in course 1 only.

Cohorts of 3-6 patients receive escalating doses of imatinib mesylate and vatalanib until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

After completion of study treatment, patients will be evaluated for 28 days.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Being tested
hydroxyurea, imatinib mesylate, vatalanib
Keywords
recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult gliosarcoma, adult giant cell glioblastoma, adult anaplastic ependymoma, adult brain stem glioma, adult mixed glioma, adult pineal gland astrocytoma
Medical subject headings
Central Nervous System Neoplasms, Brain Neoplasms, Glioblastoma, Astrocytoma, Oligodendroglioma, Gliosarcoma, Ependymoma, Glioma

What participants receive

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

  • hydroxyureaDrug

    Also called HU, hydrea

  • imatinib mesylateDrug

    Also called Gleevec

  • vatalanibDrug

    Also called PTK787

Study groups in NCT00387933
Study groupRoleWhat they receive
Gleevec + PTK787/ZK 22584 + HydroxyureaExperimentalPatients with recurrent or relapsing glioblastoma multiforme (GBM) will be given daily doses of Gleevec and PTK787/ZK 22584 orally in combination with fixed doses of hydroxyurea.
Receives: Drug: hydroxyurea; Drug: imatinib mesylate; Drug: vatalanib

What is being measured

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

  1. Maximum tolerated dose and dose-limiting toxicity of imatinib mesylate and vatalanib when administered with hydroxyurea

    Measured: 1 Year

Secondary outcomes (4)
  1. Safety

    Measured: 1.5 Years

  2. Tolerability

    Measured: 1 Year

  3. Pharmacokinetic

    To characterize the single-dose and repeated-dose pharmacokinetic (PK) profiles of imatinib mesylate (in serum) and PTK787/ZK 22584 combination therapy in this patient population.

    Measured: 1.5 Years

  4. Antiangiogenic effects

    pre- and post-treatment, of imatinib mesylate, PTK787/ZK 22584 and hydroxyurea combination therapy, using Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) to evaluate changes in the extent of vascular permeability, perfusion and relative tumor blood volume; to explore assessment of tumor cellularity and tumor cell death by changes in diffusion weighted imaging magnetic resonance imaging (DWI-MRI) as quantitated by apparent diffusion coefficient maps (ADC maps).

    To note the anti-tumor activity of this regimen in terms of radiographic response, progression-free survival and overall survival.

    Measured: 1 Year

Timeline

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

  1. First posted13 Oct 2006 (estimated)
  2. Study startJul 2005
  3. Primary completionJan 2009

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00387933
Sponsor's protocol ID
Pro00006014
Other IDs
DUMC-7019-06-3R1, NOVARTIS-DUMC-7019-06-3R1
Status last verified
Nov 2012
First submitted
12 Oct 2006
Last updated
14 Oct 2015
Results posted
No

Publications

  • Reardon DA, Egorin MJ, Desjardins A, Vredenburgh JJ, Beumer JH, Lagattuta TF, Gururangan S, Herndon JE 2nd, Salvado AJ, Friedman HS. Phase I pharmacokinetic study of the vascular endothelial growth factor receptor tyrosine kinase inhibitor vatalanib (PTK787) plus imatinib and hydroxyurea for malignant glioma. Cancer. 2009 May 15;115(10):2188-98. doi: 10.1002/cncr.24213.

    PubMed 19248046

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing hydroxyurea, imatinib mesylate and vatalanib in people with Brain and Central Nervous System Tumors, run by Duke University at 1 site in United States.

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

Who may be eligible to take part?

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 14 Oct 2015. 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 United States. 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?

Maximum tolerated dose and dose-limiting toxicity of imatinib mesylate and vatalanib when administered with hydroxyurea (time frame: 1 Year). 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 NCT00387933, which also lists 1 linked publication.

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 14 Oct 2015.

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