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)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Kentuckiana Cancer Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Eisai Inc.
Information provided by:
Kentuckiana Cancer Institute
ClinicalTrials.gov Identifier:
NCT00660283
First received: April 14, 2008
Last updated: January 18, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Glioma
Drug: Temozolomide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/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 Dose Dense Therapy With Temozolomide For Newly Diagnosed Malignant High Grade Glioma

Resource links provided by NLM:


Further study details as provided by Kentuckiana Cancer Institute:

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. [ Time Frame: 1st five subjects at 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Temozolomide

    (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00660283

Locations
United States, Kentucky
Kentuckiana Cancer Institute
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Kentuckiana Cancer Institute
Eisai Inc.
Investigators
Principal Investigator: Renato V LaRocca, MD Kentuckiana Cancer Instititue
  More Information

No publications provided

Responsible Party: Renato V. LaRocca, MD, Kentuckiana Cancer Institute
ClinicalTrials.gov Identifier: NCT00660283     History of Changes
Other Study ID Numbers: KARE003, KARE 003
Study First Received: April 14, 2008
Last Updated: January 18, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Kentuckiana Cancer Institute:
GBM
Newly
diagnosed
malignant
high grade

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

ClinicalTrials.gov processed this record on October 23, 2014