Gliadel Wafer, Temozolomide and Radiation Therapy for Newly Diagnosed GBM

This study has been terminated.
(Principal Investigator has left the institution)
Sponsor:
Information provided by:
Methodist Healthcare
ClinicalTrials.gov Identifier:
NCT00548938
First received: October 23, 2007
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

The purpose of this study is to determine the safety and efficacy of the combination of Gliadel wafers plus surgery and limited field radiation therapy with concomitant temozolomide followed by temozolomide given at an extended dose schedule (metronomic schedule) in patients undergoing initial surgery for newly-diagnosed high grade glioma.


Condition Intervention Phase
Glioblastoma Multiforme
High-Grade Glioma
Drug: Gliadel wafer
Drug: Temozolomide
Radiation: External Beam Radiation Therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed by Metronomic Therapy With Temozolomide for Newly Diagnosed Malignant High Grade Glioma

Resource links provided by NLM:


Further study details as provided by Methodist Healthcare:

Primary Outcome Measures:
  • To determine the efficacy of Gliadel wafer + radiation + temozolomide in patients with newly diagnosed high grade glioma undergoing surgery as determined by time to disease progression. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Median, one year and overall survival rate. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2007
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Gliadel wafer
    Implanted at surgery
    Drug: Temozolomide
    During External Beam Radiation
    Radiation: External Beam Radiation Therapy
    60 Gy
Detailed Description:

The patient population in this Phase II clinical trial will be patients with newly diagnosed high-grade glioma undergoing initial surgery. Patients will receive Surgery + Gliadel® wafer implantation + Limited Field Radiation Therapy with concomitant daily temozolomide (75 mg/m2) followed by monthly temozolomide given at the same dose (75 mg/m2 per day for 21 days each month.

Patients will have up to 8 wafers implanted into the tumor resection cavity (depending upon its size) after maximal tumor resection. Between Study Days 14 and 45 all patients will begin a standard course of post-operative limited field radiation therapy to the tumor site and a surrounding margin. Temozolomide will be administered concomitantly with radiation at a daily dose of 75 mg/m2 daily (7 days/week) and then beginning no later than 30 days following completion of radiation therapy on a 75 mg/m2 daily dose given 21 days out of each month for a total of up to 18 cycles.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, must be between ages 18-72
  • Patients must have radiographic evidence on cranial magnetic resonance imaging (MRI) of a single, contrast-enhancing unilateral supratentorial cerebral tumor suggestive of high-grade glioma
  • Surgical treatment within 4 weeks of the baseline MRI is indicated
  • Karnofsky Performance Score of 60 or higher
  • Patients must have a pathological diagnosis of high-grade (IV) malignant glioma
  • Patients must be willing to use a barrier method of contraception if fertile or if of childbearing potential for up to 2 years after wafer implantation and be counseled regarding the unknown, and potentially harmful, risks to the embryo or fetus while treated on this study

Exclusion Criteria:

  • Patients who have had prior cytoreductive surgery for high-grade glioma (patients who have had a diagnostic stereotactic biopsy are eligible)
  • Patients with more than one focus of tumor or tumor crossing the midline as assessed by coronal cranial MRI scan
  • Concomitant significant life-threatening disease from which the patient could reasonably be expected to die within the first 12 months of the study
  • Known hypersensitivity reactions to temozolomide, nitrosoureas or any components of the Gliadel wafer
  • Prior CNS radiotherapy
  • Patients who have received any prior chemotherapy for malignant glioma prior to the baseline evaluation or patients who are currently being treated with chemotherapeutic agents
  • Patients with fewer than 100,000 platelets per mm3 or fewer than 3,500 leukocytes per mm3
  • Liver function tests greater than or equal to 2.5 times the upper limit of normal (transaminases (SGOT, SGPT), total bilirubin, alkaline phosphatase)
  • Serum creatinine equal to or greater than 1.5 times the upper limit of normal, blood urea nitrogen (BUN) equal to or greater than 2.5 times the upper limit of normal
  • Pregnancy, or lactating females or females of childbearing potential not employing adequate contraception
  • Participation in any other investigational protocol in the prior twelve months for any type of malignancy
  • Psychological, familial, sociological or geographical conditions which do not permit adequate medical follow-up and compliance with the study protocol
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548938

Locations
United States, Tennessee
Methodist University Hospital
Memphis, Tennessee, United States, 38104
Sponsors and Collaborators
Methodist Healthcare
Investigators
Principal Investigator: Allen K Sills, MD Methodist University Hospital
  More Information

No publications provided

Responsible Party: Allen Sills, MD, Methodist Healthcare
ClinicalTrials.gov Identifier: NCT00548938     History of Changes
Other Study ID Numbers: MHIRB #2007-040
Study First Received: October 23, 2007
Last Updated: September 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Methodist Healthcare:
Brain Tumor
GBM
Glioblastoma Multiforme
Giladel
Temozolomide

Additional relevant MeSH terms:
Glioblastoma
Glioma
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Dacarbazine
Carmustine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014