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Childhood High-grade Cerebral AstrocytomaPhase 2NCT00070525

Tipifarnib in Treating Young Patients With Recurrent or Progressive High-Grade Glioma, Medulloblastoma, Primitive Neuroectodermal Tumor, or Brain Stem Glioma

A Phase 2 study testing tipifarnib in people with Childhood High-grade Cerebral Astrocytoma and Childhood Oligodendroglioma, run by National Cancer Institute (NCI) 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

This phase II trial is studying how well tipifarnib works in treating young patients with recurrent or progressive high-grade glioma, medulloblastoma, primitive neuroectodermal tumor, or brain stem glioma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Read more about this study

Who is it for?
Ages Up to 21 years
What is being tested?
tipifarnib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteUnited States
Study dates
Nov 2003to Sep 2006
Phase
Phase 2
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

Who may be able to join

  • Histologically confirmed brain tumor, including the following:
  • Anaplastic astrocytoma
  • Glioblastoma multiforme
  • Gliosarcoma
  • Anaplastic oligodendroglioma
  • Medulloblastoma/primitive neuroectodermal tumor (PNET)
Show all 129Show fewer
  • Diffuse intrinsic brain stem glioma*
  • Progressive or relapsed disease after prior conventional therapy
  • Radiographic evidence of measurable disease
  • Performance status - Karnofsky 60-100% (over 16 years of age)
  • Performance status - Lansky 60-100% (16 years of age and under)
  • Performance status - ECOG 0-2
  • At least 8 weeks
  • Absolute neutrophil count at least 1,000/mm^3
  • Platelet count at least 100,000/mm^3 (transfusion independent)
  • Hemoglobin at least 8.0 g/dL (red blood cell transfusions allowed)
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGPT and SGOT less than 2.5 times ULN
  • Creatinine clearance OR radioisotope glomerular filtration rate at least 70 mL/min
  • Maximum creatinine based on age as follows:
  • 0.8 mg/dL (5 years and under)
  • 1.0 mg/dL (6 to 10 years)
  • 1.2 mg/dL (11 to 15 years)
  • 1.5 mg/dL (over 15 years)
  • Shortening fraction at least 27% by echocardiogram
  • Ejection fraction at least 50% by MUGA
  • No dyspnea at rest
  • No exercise intolerance
  • Pulse oximetry greater than 94%*
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Seizure disorder is allowed provided it is well-controlled on non-enzyme-inducing anticonvulsants
  • No active graft-versus-host disease
  • No uncontrolled infection
  • No allergy to azoles (e.g., ketoconazole, itraconazole, or fluconazole)
  • Recovered from prior immunotherapy
  • At least 7 days since prior antineoplastic biologic agents
  • At least 1 month since prior autologous stem cell transplantation (SCT)
  • At least 6 months since prior allogeneic SCT
  • More than 1 week since prior growth factors
  • No concurrent immunomodulating agents
  • More than 2 weeks since prior myelosuppressive chemotherapy (4-6 weeks for nitrosoureas or temozolomide) and recovered
  • No concurrent anticancer chemotherapy
  • Concurrent dexamethasone allowed provided patient is on a stable or decreasing dose for at least 1 week prior to study entry
  • Concurrent corticosteroids allowed only for treatment of increased intracranial pressure
  • Recovered from prior radiotherapy
  • At least 2 weeks since prior local palliative radiotherapy (small port)
  • At least 3 months since prior craniospinal radiotherapy
  • At least 6 weeks since other prior substantial bone marrow radiotherapy
  • No concurrent palliative radiotherapy
  • No prior initiation of therapy on another phase II study
  • No concurrent participation in another therapeutic COG study
  • No concurrent enzyme-inducing anticonvulsants
  • No other concurrent anticancer or experimental drugs
  • No concurrent foods or medications that interfere with CYP3A4, including any of the following:
  • Carbamazepine
  • Phenytoin
  • Phenobarbital
  • Grapefruit juice
  • Erythromycin
  • Azithromycin
  • Clarithromycin
  • Rifampin and its analogues
  • Fluconazole
  • Ketoconazole
  • Itraconazole
  • Cimetidine
  • Cannabinoids (i.e., marijuana or dronabinol)
  • Omeprazole
  • Hypericum perforatum (St. John's wort)
  • Ethosuximide
  • Glucocorticoids
  • Griseofulvin
  • Nafcillin
  • Nelfinavir
  • Norfloxacin
  • Norfluoxetine
  • Nevirapine
  • Oxcarbazepine
  • Phenylbutazone
  • Primidone
  • Progesterone (all progestins)
  • Rifabutin
  • Rofecoxib
  • Sulfadimidine
  • Sulfinpyrazone
  • Troglitazone
  • Rifapentine
  • Modafinil
  • Amiodarone
  • Anastrozole
  • Clotrimazole
  • Cyclosporine
  • Danazol
  • Delavirdine
  • Diethyldithiocarbamate
  • Diltiazem
  • Dirithromycin
  • Disulfiram
  • Entacapone (high dose)
  • Ethinyl estradiol
  • Fluoxetine
  • Fluvoxamine
  • Gestodene
  • Indinavir
  • Isoniazid
  • Metronidazole
  • Mibefradil
  • Miconazole
  • Nefazodone
  • Oxiconazole
  • Paroxetine
  • Propoxyphene
  • Roxithromycin
  • Quinidine
  • Quinine
  • Quinupristin and dalfopristin
  • Ranitidine
  • Ritonavir
  • Saquinavir
  • Sertindole
  • Sertraline
  • Troleandomycin
  • Valproic acid
  • Verapamil
  • Voriconazole
  • Zafirlukast
  • Zileuton

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Children's Oncology Group

    Arcadia, California, 91006-3776

Other trials in United States

About this study

Official title: A Phase II Study of R115777 (Zarnestra) (NSC # 702818, IND# 58,359) in Children With Recurrent or Progressive: High Grade Glioma, Medulloblastoma/PNET or Brainstem Glioma

This phase II trial is studying how well tipifarnib works in treating young patients with recurrent or progressive high-grade glioma, medulloblastoma, primitive neuroectodermal tumor, or brain stem glioma. Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

Read the detailed description

OBJECTIVES:

  1. Determine the response rate in pediatric patients with recurrent or progressive high-grade glioma, medulloblastoma/primitive neuroectodermal tumor (PNET), or brain stem glioma treated with tipifarnib.

II. Determine the distribution of time to progression, time to treatment failure, and time to death in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study. Patients are stratified according to disease (high-grade glioma vs recurrent or progressive medulloblastoma/primitive neuroectodermal tumor [PNET] vs progressive diffuse, intrinsic brain stem glioma).

Patients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Being tested
tipifarnib
Medical subject headings
Astrocytoma, Oligodendroglioma, Medulloblastoma, Optic Nerve Glioma

What participants receive

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

  • tipifarnibDrug

    Given orally

Study groups in NCT00070525
Study groupRoleWhat they receive
Arm IExperimentalPatients receive oral tipifarnib twice daily on days 1-21. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Receives: Drug: tipifarnib

What is being measured

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

  1. Best objective tumor response rates (complete and partial response), based on MRIs

    Estimated ultimately as a simple binomial proportion. Estimated actuarially, using the product-limit (PL) estimate.

    Measured: Up to 2 years

  2. Time to tumor progression (TTP)

    The distribution of TTP will be analyzed using PL estimate.

    Measured: Time from study enrollment to radiographically determined tumor progression or recurrence, assessed up to 2 years

  3. Time to treatment failure (TTF)

    The distribution of TTF will be analyzed using PL estimate.

    Measured: Time from study enrollment to tumor progression, tumor recurrence, death from any cause, or occurrence of a second malignant neoplasm, assessed up to 2 years

  4. Time to death (TTD)

    The distribution of TTD will be analyzed using PL estimate.

    Measured: Time from study enrollment to death from any cause, assessed up to 2 years

  5. Incidence of adverse events graded according to NCI CTCAE version 3.0

    Measured: Up to 2 years

Timeline

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

  1. First posted7 Oct 2003 (estimated)
  2. Study startNov 2003
  3. Primary completionSep 2006

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00070525
Sponsor's protocol ID
NCI-2012-01806
Other IDs
NCI-2012-01806, CDR0000334862, COG-ACNS0226, ACNS0226, ACNS0226, U10CA098543
Status last verified
Oct 2013
First submitted
3 Oct 2003
Last updated
8 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tipifarnib in people with Childhood High-grade Cerebral Astrocytoma and Childhood Oligodendroglioma, run by National Cancer Institute (NCI) 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?

The sponsor lists 129 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 8 Oct 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Best objective tumor response rates (complete and partial response), based on MRIs (time frame: Up to 2 years). The study lists 5 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 NCT00070525.

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 8 Oct 2013.

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