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A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

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Trial Information

A Phase II Study of Temozolomide in the Treatment of Recurrent Malignant Gliomas


OBJECTIVES:

- Determine the progression-free survival and response rate of patients with recurrent or
progressive malignant glioma treated with temozolomide.

- Determine whether certain categories of malignant gliomas, such as oligodendroglioma,
are more sensitive to temozolomide.

- Determine the toxicity of this regimen in these patients.

OUTLINE: Patients are stratified according to histologic categories (recurrent glioblastoma
multiforme [closed to accrual 11/30/01] vs recurrent anaplastic astrocytoma vs recurrent
anaplastic oligodendroglioma).

Patients receive oral temozolomide twice daily for 5 consecutive days. Courses repeat every
28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven recurrent or progressive malignant glioma of one of the
following types:

- Anaplastic oligodendroglioma or oligoastrocytoma

- Anaplastic astrocytoma

- Glioblastoma multiforme (stratum closed to accrual 11/30/01)

- Patients who have failed radiotherapy are eligible

- Measurable disease by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 70-100%

Life expectancy:

- At least 12 weeks

Hematopoietic:

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 10 g/dL

Hepatic:

- SGOT or SGPT less than 3 times upper limit of normal (ULN)

- Alkaline phosphatase less than 2 times ULN (if greater than 2 times ULN then a gamma
glutamyl transferase test must be performed)

Renal:

- BUN less than 1.5 times ULN

- Creatinine less than 1.5 times ULN

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

- No other serious concurrent infection or other medical illness that would preclude
study entry

- No frequent vomiting or partial bowel obstruction

- HIV negative

- No AIDS-related illness

- No other concurrent malignancy except carcinoma in situ of the cervix or basal cell
skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent epoetin alfa

Chemotherapy:

- At least 6 weeks since other prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 3 months since prior radiotherapy (exceptions allowed for
recurrent/progressive disease at discretion of primary investigator)

Surgery:

- Recovered from prior surgery

Other:

- No other concurrent investigational agents

- Concurrent anticonvulsant therapy allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Casilda Balmaceda, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Herbert Irving Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067449

NCT ID:

NCT00004204

Start Date:

February 2000

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioma

Name

Location

Stanford University Medical CenterStanford, California  94305-5408
Cancer Center of Albany Medical CenterAlbany, New York  12208
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140
Froedtert Memorial Lutheran HospitalMilwaukee, Wisconsin  53226
Nalitt Institute for Cancer And Blood Related DiseasesStaten Island, New York  10305
Neurological ClinicPortland, Oregon  97210