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A Randomized Phase II Trial of Concurrent Temozolomide and Radiotherapy Followed by Dose Dense Versus Metronomic Temozolomide and Maintenance Cis-Retinoic Acid for Patients With Newly Diagnosed Glioblastoma and Other Malignant Gliomas


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Glioblastoma, Gliomas

Thank you

Trial Information

A Randomized Phase II Trial of Concurrent Temozolomide and Radiotherapy Followed by Dose Dense Versus Metronomic Temozolomide and Maintenance Cis-Retinoic Acid for Patients With Newly Diagnosed Glioblastoma and Other Malignant Gliomas


This is a randomized phase II study that will test two different adjuvant temozolomide
regimens in patients with newly diagnosed glioblastoma multiforme. The goal of this study
is to identify a regimen that would be appropriate to bring to a phase III trial and compare
to the standard dosing regimen of temozolomide recently reported by Stupp et al. in the New
England Journal of Medicine. Secondary goals of this study include: prospective analysis of
the prognostic impact of MGMT status and generation of preliminary data regarding this
treatment strategy for other types of malignant glioma.

The decision regarding which treatment patients receive is made randomly. Neither them or
their doctor can select which treatment the patient will receive. There is reason to believe
that both of these doses may benefit treating your brain tumor. After 6 months of
chemotherapy, and assuming the brain tumor has not shown any sign of growth, they will begin
receiving cis-retinoic acid. Cis retinoic acid has been shown in one study to possibly
prevent or delay tumor recurrence.


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the 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.

Outcome Time Frame:

until death or date of last follow up

Safety Issue:

No

Principal Investigator

Lisa DeAngelis, M.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

05-079

NCT ID:

NCT00200161

Start Date:

August 2005

Completion Date:

August 2013

Related Keywords:

  • Glioblastoma
  • Gliomas
  • Glioblastoma
  • Glioma

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021
Memorial Sloan-Kettering Cancer Center at Commack Commack, New York  11725
Memorial Sloan-Kettering at Basking Ridge Basking Ridge, New Jersey  07920