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A Phase I Study of Extended Low Dose Temozolomide (SCH 52365, Temodar (R)) and Carmustine (BCNU) in the Treatment of Malignant Gliomas After Radiation Therapy


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

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Trial Information

A Phase I Study of Extended Low Dose Temozolomide (SCH 52365, Temodar (R)) and Carmustine (BCNU) in the Treatment of Malignant Gliomas After Radiation Therapy


OBJECTIVES:

- Determine the safety and efficacy of extended low-dose temozolomide when combined with
carmustine after radiotherapy in patients with malignant glioma.

- Determine the maximum tolerated dose of this combination in this patient population.

- Determine time to progression as measured from baseline gadolinium-enhanced magnetic
resonance imaging in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of temozolomide.

Patients receive oral temozolomide once daily on days 1-28 and carmustine IV over 1-3 hours
beginning within 72 hours after starting temozolomide. Courses repeat every 8 weeks for up
to 1 year in the absence of unacceptable toxicity or disease progression.

Cohorts of 3-6 patients receive escalating doses of temozolomide until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
patients experience dose-limiting toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 1-2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed malignant glioma

- Glioblastoma

- Gliosarcoma

- High-grade glioma

- Anaplastic astrocytoma

- Anaplastic mixed oligoastrocytoma

- Anaplastic oligodendroglioma

- Anaplastic ependymoma

- Must have completed radiotherapy

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- More than 3 months

Hematopoietic:

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL

Hepatic:

- Bilirubin less than 1.5 times upper limit of normal (ULN)

- SGOT/SGPT less than 3 times ULN

- Alkaline phosphatase less than 2 times ULN

Renal:

- BUN less than 1.5 times ULN

- Creatinine less than 1.5 times ULN

Pulmonary:

- Pulmonary function test with diffusion greater than 50 OR

- Clearance by the pulmonary service

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- HIV negative

- No AIDS-related illness

- No nonmalignant systemic disease that would preclude study

- No acute infection requiring IV antibiotics

- No psychiatric condition that would preclude study compliance

- No frequent vomiting or medical condition that would interfere with oral medication
intake (e.g., partial bowel obstruction)

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior immunotherapy

- No prior biologic therapy

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- See Disease Characteristics

- At least 2 weeks since prior radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jeffrey J. Raizer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067793

NCT ID:

NCT00005637

Start Date:

December 1999

Completion Date:

December 2009

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • adult anaplastic ependymoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021