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Completed

NCT Number: NCT00200161

Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma

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.

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Key information

Conditions

Glioblastoma Astrocytoma Glioma Gliomas Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan-Kettering at Basking Ridge, Basking Ridge, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Temozolomide

Drug

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.

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.

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

Secondary outcomes

  1. Progression Free Survival at 6 Months

    Time frame: 6 months

  2. Prognostic Impact of Methylated MGMT Status.

    Time frame: through study completion, an average of 1 year

    MGMT promoter methylation is currently considered the main prognostic biomarker in glioblastoma. Methylation MGMT status will be assessed using real-time PCR.

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

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • Columbia University
  • Dana-Farber Cancer Institute
  • Schering-Plough

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2017
Study completion
2017
First posted
Sep 20, 2005
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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