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

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00238277
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 15
• Location: 1
• Actual Duration (Months): 33.8
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain and Central Nervous System Tumors	Drug: temozolomide; Procedure: adjuvant therapy; Procedure: chemotherapy; Procedure: radiation therapy	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Study of Temozolomide and Radiation in Newly Diagnosed GBM Patients After Resection and Insertion of Gliadel® Wafers
• Actual Study Start Date: Feb 15, 2005
• Actual Primary Completion Date: Dec 11, 2007
• Actual Study Completion Date: Dec 11, 2007

Outcome Measures

Primary Outcome Measures

1. Death []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Stuart A. Grossman, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT00238277
• Other Study ID Numbers: J0498; P30CA006973; CDR0000445270; 04-12-16-03
• First Posted: Oct 13, 2005
• Last Update Posted: Jun 27, 2018
• Last Verified: Jun 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma
• Additional relevant MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Temozolomide

Study Results

No Results Posted as of Jun 27, 2018