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Brain and Central Nervous System TumorsPhase 1NCT00015899

SCH 66336 in Treating Children With Recurrent or Progressive Brain Tumors

A Phase 1 study testing lonafarnib in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 9 sites 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: SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: This phase I trial is studying the side effects and best dose of SCH 66336 in treating children with recurrent or progressive brain tumors. Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Brain and Central Nervous System Tumors
What is being tested?
lonafarnib
How many people
53 participants
Where
9 sitesUnited States
Study dates
Jan 2002to Mar 2007
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 Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed recurrent or progressive (refractory) brain tumors
  • Histologic confirmation waived for brainstem gliomas
  • Bone marrow involvement allowed if transfusion independent

PATIENT CHARACTERISTICS:

Age:

  • 21 and under

Performance status:

  • Lansky 60-100% OR
  • Karnofsky 60-100%

Life expectancy:

  • More than 8 weeks

Hematopoietic:

  • See Disease Characteristics
  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 75,000/mm^3
  • Hemoglobin greater than 9 g/dL

Hepatic:

  • Bilirubin no greater than upper limit of normal
  • SGPT and SGOT less than 2.5 times normal
  • Albumin greater than 3 g/dL
  • PT/PTT no greater than 120% upper limit of normal
  • No overt hepatic disease

Renal:

  • Creatinine no greater than 1.5 times normal OR
  • Glomerular filtration rate greater than 70 mL/min
  • No overt renal disease

Cardiovascular:

  • No overt cardiac disease

Pulmonary:

  • No overt pulmonary disease

Other:

  • Neurologic deficits allowed if stable for at least 1 week prior to study
  • More than 3rd percentile weight for height
  • Able to swallow pills
  • No uncontrolled infection
  • No known or suspected allergy to poloxamer 188, croscarmellose sodium, silicon dioxide, or magnesium stearate I
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 10 weeks after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • More than 6 months since prior bone marrow transplantation
  • More than 1 week since prior growth factors

Chemotherapy:

  • At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered

Endocrine therapy:

  • Concurrent dexamethasone allowed if on stable dose for at least 1 week prior to study
  • Concurrent oral contraceptives or other hormonal contraceptive methods allowed

Radiotherapy:

  • More than 6 weeks since prior substantial bone marrow radiotherapy
  • More than 3 months since prior craniospinal radiotherapy (more than 24 Gy) or total body irradiation
  • More than 2 weeks since prior focal radiotherapy for symptomatic metastatic sites

Surgery:

  • Not specified

Other:

  • No concurrent enzyme-inducing anticonvulsant drugs
  • No other concurrent anticancer or experimental drug therapy

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Texas Children's Cancer Center

    Houston, Texas, 77030-2399

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105-2794

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104-4318

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94143-0372

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

Other trials in United States

About this study

Official title: Phase I Trial Of Escalating Oral Doses Of SCH 66336 In Pediatric Patients With Refractory Or Recurrent Brain Tumors

RATIONALE: SCH 66336 may stop the growth of tumor cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: This phase I trial is studying the side effects and best dose of SCH 66336 in treating children with recurrent or progressive brain tumors.

Read the detailed description

OBJECTIVES:

  • Determine the qualitative and quantitative toxicity of SCH 66336 in children with recurrent or progressive brain tumors.
  • Estimate the maximum tolerated dose of this drug in these patients.
  • Describe the pharmacokinetics of this drug with and without dexamethasone in these patients.
  • Investigate the efficacy of this drug in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive oral SCH 66336 twice daily. Treatment repeats every 4 weeks for a total of 26 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 1-6 patients receive escalating doses of SCH 66336 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which it is predicted that 20% of patients may experience dose-limiting toxicity. An additional 6 patients are treated at the determined MTD.

Patients are followed within 30 days of the last administration of the study drug and then for up to 3 months.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

Being tested
lonafarnib
Keywords
childhood craniopharyngioma, childhood central nervous system germ cell tumor, childhood oligodendroglioma, childhood choroid plexus tumor, childhood grade I meningioma, childhood grade II meningioma, childhood grade III meningioma, recurrent childhood cerebellar astrocytoma, recurrent childhood cerebral astrocytoma, recurrent childhood medulloblastoma, recurrent childhood visual pathway and hypothalamic glioma, recurrent childhood ependymoma, childhood atypical teratoid/rhabdoid tumor, childhood spinal cord neoplasm
Medical subject headings
Central Nervous System Neoplasms, Oligodendroglioma, Choroid Plexus Neoplasms, Astrocytoma, Medulloblastoma, Optic Nerve Glioma, Familial ependymoma, Rhabdoid Tumor

What participants receive

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

  • lonafarnibDrug

    Also called SCH 66336

What is being measured

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

  1. Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers

  2. Maximum tolerated dose of SCH 66336

    Measured: Four weeks

  3. Pharmacokinetics of SCH 66336

Secondary outcomes (1)

  1. Tumor response to SCH 66336

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startJan 2002
  3. Primary completionSep 2005
  4. Study completionMar 2007

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
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00015899
Sponsor's protocol ID
CDR0000068571
Other IDs
PBTC-003, SPRI-P02201
Status last verified
Oct 2009
First submitted
6 May 2001
Last updated
14 Oct 2009
Results posted
No
Data monitoring committee
Yes

Publications

  • Kieran MW, Packer RJ, Onar A, Blaney SM, Phillips P, Pollack IF, Geyer JR, Gururangan S, Banerjee A, Goldman S, Turner CD, Belasco JB, Broniscer A, Zhu Y, Frank E, Kirschmeier P, Statkevich P, Yver A, Boyett JM, Kun LE. Phase I and pharmacokinetic study of the oral farnesyltransferase inhibitor lonafarnib administered twice daily to pediatric patients with advanced central nervous system tumors using a modified continuous reassessment method: a Pediatric Brain Tumor Consortium Study. J Clin Oncol. 2007 Jul 20;25(21):3137-43. doi: 10.1200/JCO.2006.09.4243.

    PubMed 17634493

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing lonafarnib in people with Brain and Central Nervous System Tumors, run by Pediatric Brain Tumor Consortium at 9 sites 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 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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?

Toxicities of SCH 66336 in children and adolescents with refractory CNS cancers. The study lists 3 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 NCT00015899, 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 2009.

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