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Temozolomide During and After Radiation Therapy in Treating Patients Who Have Undergone Previous Surgery and Placement of Gliadel Wafers for Newly Diagnosed Glioblastoma Multiforme

Primary Purpose

Brain and Central Nervous System Tumors

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
temozolomide
adjuvant therapy
chemotherapy
radiation therapy
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme) Underwent gross total resection within the past 6 weeks Postoperative contrast-enhancing tumor extends ≤ 1 cm from the margin of the surgical cavity 6-8 polifeprosan 20 with carmustine implants (Gliadel® wafers) were placed in the surgical resection cavity at time of surgery PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL Transaminases ≤ 4 times upper limit of normal Renal Creatinine ≤ 1.7 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known hypersensitivity reaction to temozolomide No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for the brain tumor No prior biologic agents (e.g., immunotoxins, immunoconjugates, antisense agents, peptide-receptor agonists, interferons, interleukins, tumor-infiltrating lymphocyte therapy, lymphokine-activated killer cell therapy, or gene therapy) for the brain tumor Chemotherapy See Disease Characteristics No other prior chemotherapy for the brain tumor Endocrine therapy No prior hormonal therapy for the brain tumor Prior glucocorticoid therapy allowed Radiotherapy No prior radiotherapy for the brain tumor Surgery See Disease Characteristics

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcomes

Primary Outcome Measures

Death

Secondary Outcome Measures

Full Information

First Posted
October 12, 2005
Last Updated
June 25, 2018
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00238277
Brief Title
Temozolomide During and After Radiation Therapy in Treating Patients Who Have Undergone Previous Surgery and Placement of Gliadel Wafers for Newly Diagnosed Glioblastoma Multiforme
Official Title
Phase II Study of Temozolomide and Radiation in Newly Diagnosed GBM Patients After Resection and Insertion of Gliadel® Wafers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Terminated
Why Stopped
Terminated - due to low accrual
Study Start Date
February 15, 2005 (Actual)
Primary Completion Date
December 11, 2007 (Actual)
Study Completion Date
December 11, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving temozolomide during and after radiation therapy may kill any tumor cells that remain after surgery and placement of Gliadel wafers. PURPOSE: This phase II trial is studying how well giving temozolomide during and after radiation therapy works in treating patients who have undergone previous surgery and placement of Gliadel wafers for newly diagnosed glioblastoma multiforme.
Detailed Description
OBJECTIVES: Determine the efficacy of adjuvant temozolomide when administered during and after external beam radiotherapy, in terms of survival, in patients with newly diagnosed glioblastoma multiforme who have undergone prior total surgical resection and placement of polifeprosan 20 with carmustine implant (Gliadel® wafers). OUTLINE: This is an open-label study. Patients undergo external beam radiotherapy 5 days a week for 6 weeks and concurrently receive oral temozolomide once daily for 6 weeks. No more than 28 days later, patients receive additional oral temozolomide once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 2 months for survival. PROJECTED ACCRUAL: A total of 72 patients will be accrued for this study within 18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
chemotherapy
Intervention Type
Procedure
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Death

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed supratentorial grade IV astrocytoma (glioblastoma multiforme) Underwent gross total resection within the past 6 weeks Postoperative contrast-enhancing tumor extends ≤ 1 cm from the margin of the surgical cavity 6-8 polifeprosan 20 with carmustine implants (Gliadel® wafers) were placed in the surgical resection cavity at time of surgery PATIENT CHARACTERISTICS: Age 18 and over Performance status Karnofsky 60-100% Life expectancy Not specified Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 mg/dL Transaminases ≤ 4 times upper limit of normal Renal Creatinine ≤ 1.7 mg/dL Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known hypersensitivity reaction to temozolomide No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No prior immunotherapy for the brain tumor No prior biologic agents (e.g., immunotoxins, immunoconjugates, antisense agents, peptide-receptor agonists, interferons, interleukins, tumor-infiltrating lymphocyte therapy, lymphokine-activated killer cell therapy, or gene therapy) for the brain tumor Chemotherapy See Disease Characteristics No other prior chemotherapy for the brain tumor Endocrine therapy No prior hormonal therapy for the brain tumor Prior glucocorticoid therapy allowed Radiotherapy No prior radiotherapy for the brain tumor Surgery See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart A. Grossman, MD
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Temozolomide During and After Radiation Therapy in Treating Patients Who Have Undergone Previous Surgery and Placement of Gliadel Wafers for Newly Diagnosed Glioblastoma Multiforme

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