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A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed By Dose Dense Therapy With Temozolomide For Newly Diagnosed Malignant High Grade Glioma (KARE003)

Primary Purpose

Glioma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Temozolomide
Sponsored by
Kentuckiana Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioma focused on measuring GBM, Newly, diagnosed, malignant, high grade

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects, men and women, must be between ages 18 and 75 years.
  2. Subjects must have radiographic evidence on cranial magnetic resonance imaging (MRI) of a single, contrast-enhancing unilateral supratentorial cerebral tumor (see Section 8.4).

3 Surgery is recommended within 4 weeks of the baseline MRI scan.

4. Subjects must have a Karnofsky Performance Score of 60 or higher.

5. 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.

6. Subjects must have a pathological diagnosis of a high grade (IV) malignant glioma.

7. 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.

Exclusion Criteria:

  1. Subjects who have had prior cytoreductive surgery for high-grade glioma. Subjects who have had a diagnostic stereotactic biopsy are eligible.
  2. Subjects with more than one focus of tumor or tumor crossing the midline as assessed by coronal cranial MRI scan.
  3. Concomitant significant life-threatening disease from which the subject could reasonably be expected to die within the first 12 months of the study.
  4. Known hypersensitivity reactions to temozolomide, nitrosoureas or any other components of the Gliadel® wafer.
  5. Prior CNS radiotherapy.
  6. 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.
  7. Subjects with fewer than 100,000 platelets per mm3 or fewer than 3.500 leukocytes per mm3.
  8. Liver function tests greater than or equal to 2.5 times the upper limit of normal (transaminases (SGOT, SGPT), total bilirubin, alkaline phosphatase).
  9. 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.
  10. Pregnancy, or lactating females or females of childbearing potential not using adequate contraception.
  11. Participation in any other investigational protocol in the prior twelve months for any type of malignancy.
  12. Psychological, familial, sociological or geographical conditions which do not permit adequate medical follow-up and compliance with the study protocol.
  13. Inadequately controlled hypertension (blood pressure systolic > 150 mmHg or diastolic > 100 mmHg).
  14. Unstable angina or history of myocardial infarction within six months prior to enrollment.
  15. 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.
  16. Serious non-healing wound, ulcer, or bone fracture.

Sites / Locations

  • Kentuckiana Cancer Institute

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 14, 2008
Last Updated
January 18, 2010
Sponsor
Kentuckiana Cancer Institute
Collaborators
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00660283
Brief Title
A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed By Dose Dense Therapy With Temozolomide For Newly Diagnosed Malignant High Grade Glioma
Acronym
KARE003
Official Title
A Phase II Study of Gliadel, Concomitant Temozolomide and Radiation, Followed By Dose Dense Therapy With Temozolomide For Newly Diagnosed Malignant High Grade Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kentuckiana Cancer Institute
Collaborators
Eisai Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma
Keywords
GBM, Newly, diagnosed, malignant, high grade

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
(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.
Primary Outcome Measure Information:
Title
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.
Time Frame
1st five subjects at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). 3 Surgery is recommended within 4 weeks of the baseline MRI scan. 4. Subjects must have a Karnofsky Performance Score of 60 or higher. 5. 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. 6. Subjects must have a pathological diagnosis of a high grade (IV) malignant glioma. 7. 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. Exclusion Criteria: 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. Serious non-healing wound, ulcer, or bone fracture.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato V LaRocca, MD
Organizational Affiliation
Kentuckiana Cancer Instititue
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kentuckiana Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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