A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed By Dose Dense Therapy With Temozolomide For Newly Diagnosed Malignant High Grade Glioma

NCT00660283 | Unknown Phase 2 DMC

• 2 other identifiers: KARE003KARE 003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the safety and efficacy of surgical resection with Gliadel® 3.85% wafer implantation, followed by concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide in subjects undergoing initial surgery for newly-diagnosed high grade glioma.

Conditions

Glioma

Keywords

GBM; Newly; diagnosed; malignant; high grade

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy of concomitant limited field radiation therapy and temozolomide, followed by dose dense temozolomide in subjects undergoing initial surgery for newly-diagnosed high grade glioma.

  1st five subjects at 6 months

Interventions

Temozolomide DRUG

(Stage I Treatment) Postoperative concomitant limited-field radiation therapy with daily temozolomide (75 mg/m2) must begin between 14 and 28 days from surgery. 7\. (Stage II Treatment) temozolomide 150 mg/m2 to be given days 1-7 and 15-21 of a 28 day cycle to begin within 45 days of stop date of concomitant limited field radiation/daily temozolomide (Stage I treatment) up to a maximum of 12 cycles.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects, men and women, must be between ages 18 and 75 years.
• Subjects must have radiographic evidence on cranial magnetic resonance imaging (MRI) of a single, contrast-enhancing unilateral supratentorial cerebral tumor (see Section 8.4).
• Surgery is recommended within 4 weeks of the baseline MRI scan.
• \. Subjects must have a Karnofsky Performance Score of 60 or higher.
• \. Subjects must have signed an Institutional Review Board (IRB)-approved informed consent prior to any non-standard of care study procedure or no later than the start of dose dense temozolomide.
• \. Subjects must have a pathological diagnosis of a high grade (IV) malignant glioma.
• \. Subjects, both men and women, must be willing to avoid pregnancy for up to 2 years after wafer implantation surgery and be counseled regarding the unknown, and potentially harmful, risks to the embryo or fetus from participation in this study.

You may not qualify if:

• Subjects who have had prior cytoreductive surgery for high-grade glioma. Subjects who have had a diagnostic stereotactic biopsy are eligible.
• Subjects 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 subject could reasonably be expected to die within the first 12 months of the study.
• Known hypersensitivity reactions to temozolomide, nitrosoureas or any other components of the Gliadel® wafer.
• Prior CNS radiotherapy.
• Subjects who have received any prior chemotherapy for this malignant glioma prior to the baseline evaluation or subjects who are currently being treated with chemotherapeutic agents.
• Subjects 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 using 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.
• Inadequately controlled hypertension (blood pressure systolic \> 150 mmHg or diastolic \> 100 mmHg).
• Unstable angina or history of myocardial infarction within six months prior to enrollment.
• Evidence of bleeding, diathesis, or coagulopathy. Chronic full-dose anticoagulation with warfarin is not permitted though subjects may be on low molecular weight heparin or fondaparinux.

Sponsors & Collaborators

• Kentuckiana Cancer Institute: lead
• Eisai Inc.: collaborator

Study Sites (1)

Kentuckiana Cancer Institute

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Glioma; Disease

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Renato V LaRocca, MD

  Kentuckiana Cancer Instititue

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 17, 2008
• Study Start: January 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 20, 2010

Record last verified: 2010-01

Locations

US (1)