NCT00070525

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2003

Completed
25 days until next milestone

Study Start

First participant enrolled

November 1, 2003

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

2.8 years

First QC Date

October 3, 2003

Last Update Submit

October 7, 2013

Conditions

Childhood High-grade Cerebral AstrocytomaChildhood OligodendrogliomaRecurrent Childhood Brain Stem GliomaRecurrent Childhood Cerebellar AstrocytomaRecurrent Childhood Cerebral AstrocytomaRecurrent Childhood MedulloblastomaRecurrent Childhood Supratentorial Primitive Neuroectodermal TumorRecurrent Childhood Visual Pathway and Hypothalamic Glioma

Outcome Measures

Primary Outcomes (5)

  • 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.

    Up to 2 years

  • Time to tumor progression (TTP)

    The distribution of TTP will be analyzed using PL estimate.

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

  • Time to treatment failure (TTF)

    The distribution of TTF will be analyzed using PL estimate.

    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

  • Time to death (TTD)

    The distribution of TTD will be analyzed using PL estimate.

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

  • Incidence of adverse events graded according to NCI CTCAE version 3.0

    Up to 2 years

Study Arms (1)

Arm I

EXPERIMENTAL

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.

Drug: tipifarnib

Interventions

tipifarnibDRUG

Given orally

Arm I

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed brain tumor, including the following:
  • Anaplastic astrocytoma
  • Glioblastoma multiforme
  • Gliosarcoma
  • Anaplastic oligodendroglioma
  • Medulloblastoma/primitive neuroectodermal tumor (PNET)
  • 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)
  • +114 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

MeSH Terms

Conditions

AstrocytomaOligodendrogliomaMedulloblastomaOptic Nerve Glioma

Interventions

tipifarnib

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal Tumors, PrimitiveOptic Nerve NeoplasmsCranial Nerve NeoplasmsNervous System NeoplasmsNeoplasms by SitePeripheral Nervous System NeoplasmsCranial Nerve DiseasesNervous System DiseasesOptic Nerve DiseasesEye Diseases

Study Officials

  • Maryam Fouladi

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2003

First Posted

October 7, 2003

Study Start

November 1, 2003

Primary Completion

September 1, 2006

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

US(1)