NCT00200161

Brief Summary

Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone. Patients will receive standard low dose temozolomide during radiation. After radiation, they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
127

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

August 9, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
11.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2017

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 7, 2018

Completed
Last Updated

March 7, 2018

Status Verified

September 1, 2016

Enrollment Period

11.7 years

First QC Date

September 12, 2005

Results QC Date

January 10, 2018

Last Update Submit

March 5, 2018

Conditions

GlioblastomaGliomas

Outcome Measures

Primary Outcomes (1)

  • 12 Month Overall Survival of Patients With Newly Diagnosed Glioblastoma Multiforme Treated With Concurrent Temozolomide and Radiotherapy Followed by Dose Dense or Metronomic Dosing of Temozolomide and Maintenance Cis-retinoic Acid.

    until death or date of last follow up, an average of 12 months

Secondary Outcomes (3)

  • Progression Free Survival at 6 Months

    6 months

  • Prognostic Impact of Methylated MGMT Status.

    through study completion, an average of 1 year

  • To Collect Preliminary Data on the Efficacy of This Regimen and Impact of MGMT Status in Other Malignant Glioma Subtypes.

    through study completion, an average of 1 year

Study Arms (2)

Metronomic Therapy Cohort

ACTIVE COMPARATOR

Concurrent temozolomide and radiotherapy plus lose dose of temozolomide

Drug: Temozolomide

Dose-Dense Therapy Cohort

EXPERIMENTAL

Concurrent temozolomide and radiotherapy plus high dose of temozolomide

Drug: Temozolomide

Interventions

TemozolomideDRUG

Focal RT 6000 cGy/ Temozolomide 75 mg/m2 then Temozolomide 50mg/m2 will be given to patients on days 1-28 of each 28 day cycle. Maintenance cis-retinoic acid. This therapy will start at the completion of 6 cycles of adjuvant temozolomide in all patients who have had no clinical or radiographic evidence of tumor progression.Treatment will continue in 28 day cycles until tumor progression.

Metronomic Therapy Cohort

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologic evidence of a malignant glioma.
  • Tissue block or unstained slides must be available for MGMT analysis.
  • Age 18-70
  • KPS \> 50
  • Granulocyte count \>1.5 X 109/L
  • Platelet count \>99 X 109/L
  • SGOT \< 2.5X upper limit of normal (ULN).
  • Serum creatinine \< 2X ULN.
  • Bilirubin \< 2X ULN.
  • All patients must sign written informed consent.

You may not qualify if:

  • Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
  • Any prior experimental therapy for glioma.
  • Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
  • Serious medical or psychiatric illness that would in the opinion of the investigator would interfere with the prescribed treatment.
  • Pregnant or breast feeding women.
  • Refusal to use effective contraception.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Memorial Sloan-Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan-Kettering Cancer Center at Commack

Commack, New York, 11725, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

MeSH Terms

Conditions

GlioblastomaGlioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

AstrocytomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Lisa Deangelis
Organization
Memorial Sloan Kettering Cancer Center
deangell@mskcc.org
212-639-7997

Study Officials

  • Lisa DeAngelis, M.D

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 9, 2005

Primary Completion

May 4, 2017

Study Completion

May 4, 2017

Last Updated

March 7, 2018

Results First Posted

March 7, 2018

Record last verified: 2016-09

Locations

US(3)