NCT00038389

Brief Summary

It is of interest to determine whether COX-2 inhibitors given with radiation therapy can prolong the progression-free survival in brain stem glioma. Diffuse pontine brainstem gliomas are more common in children, but are also seen in adults. However, the use of commercially available COX-2 inhibitors has not been evaluated in the pediatric population and the proper dosing in pediatrics is unknown. Therefore a Phase I study will need to be conducted as a first step. Rofecoxib is an FDA approved COX-2 inhibitor for use in adults. This phase I study is designed to determine the maximum tolerated dose of Rofecoxib given concurrently with standard radiation therapy for diffuse pontine brainstem glioma.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2001

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 31, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2004

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

November 1, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

May 30, 2002

Last Update Submit

October 30, 2018

Conditions

GliomaBrain Neoplasms

Keywords

Brain Stem Tumor

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose of VIOXX (rofecoxib) with 6 weeks of daily cranial radiation therapy

    Maximum Tolerated Dose defined using each level's dose limiting toxicity (DLT) and continuous reassessment method (CRM).

    1 month following radiation therapy

Study Arms (1)

Vioxx MTD

EXPERIMENTAL
Drug: Vioxx

Interventions

VioxxDRUG

Starting dose for patients age 3-14 years 10.0 mg/1.73 m2 and for patients above 14 years of age 12.5 mg for 5 days per week for 6 weeks during radiation treatment, and 7 days per week for 6 months after radiation treatment.

Also known as: Rofecoxib
Vioxx MTD

Eligibility Criteria

Age3 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Newly diagnosed infiltrating lesion involving the pons and an MRI pattern of diffuse infiltration, that is not focal. The tumor may extend beyond the boundary of the pons.
  • MRI of the brain with or without gadolinium within 4 weeks of starting therapy.
  • Clinical history \< 6 months duration
  • Children \>3 years of age and adults \>18 years of age
  • Treatment to begin within 6 weeks of diagnosis.
  • Written informed consent
  • Performance status: ECOG 0,1,2 or equivalent Lansky Play Performance Scale.
  • All patients must have adequate bone marrow function (ANC\>1000, platelets \>100,000, SGPT \< 2.5x ULN) and renal function (creatinine clearance \>50/ml/min/1.73 m2 or age-adjusted serum creatinine \< 3x ULN)
  • MRI of the spine within 4 weeks of starting therapy.

You may not qualify if:

  • Pregnancy. All participants who are of child-bearing age must agree to use a method of birth control/pregnancy prevention.
  • Bilirubin \> 3x ULN.
  • History of gastrointestinal bleeding.
  • History of GI perforation due to ulcerative disease.
  • Patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Prior therapy (Dexamethasone is not considered therapy.)
  • Prior malignancy
  • Metastasis to the spine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

GliomaBrain NeoplasmsBrain Stem Neoplasms

Interventions

rofecoxib

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesInfratentorial Neoplasms

Study Officials

  • Eric L. Chang, MD

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2002

First Posted

May 31, 2002

Study Start

October 1, 2001

Primary Completion

October 1, 2004

Study Completion

January 1, 2005

Last Updated

November 1, 2018

Record last verified: 2018-10

Locations

US(1)