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Phase II Study of Temozolomide and Radiation in Newly Diagnosed GBM Patients After Resection and Insertion of Gliadel® Wafers


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase II Study of Temozolomide and Radiation in Newly Diagnosed GBM Patients After Resection and Insertion of Gliadel® Wafers


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Death

Safety Issue:

No

Principal Investigator

Stuart A. Grossman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

Unspecified

Study ID:

CDR0000445270

NCT ID:

NCT00238277

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410