Know Cancer

forgot password

A Phase II Trial of Temozolomide and BCNU for Anaplastic Gliomas

Phase 2
18 Years
Open (Enrolling)
Brain and Central Nervous System Tumors

Thank you

Trial Information

A Phase II Trial of Temozolomide and BCNU for Anaplastic Gliomas

OBJECTIVES: I. Evaluate the activity, measured in terms of progression free survival, of
carmustine plus temozolomide in recurrent glioblastoma. II. Estimate the response rate of
recurrent glioblastomas to this combination. III. Estimate the response rate of newly
diagnosed anaplastic astrocytomas and mixed anaplastic glioma to this combination. IV.
Evaluate the qualitative and quantitative toxicities of this combination in patients with
anaplastic gliomas.

OUTLINE: This is a nonrandomized study. Patients are stratified by disease (recurrent
glioblastoma vs anaplastic astrocytoma or mixed anaplastic glioma). Patients receive
carmustine intravenously on day 1 two hours prior to temozolomide. Temozolomide is
administered orally on day 1. Cycles repeat every 42 days. Treatment for patients with
recurrent glioblastoma may continue for 8 cycles in the absence of disease progression or
unacceptable toxicity. If there is no disease progression after 8 cycles, treatment may
continue further at the investigator's discretion. Patients with anaplastic astrocytoma or
mixed anaplastic glioma continue for 4 cycles of treatment. Patients are followed
periodically at the investigator's discretion, at least twice in the first 4 months, and
then until death.

PROJECTED ACCRUAL: A minimum of 17 patients and a maximum of 37 patients will be accrued in
the recurrent glioblastoma stratum and 45 patients will be accrued into the anaplastic
astrocytoma and mixed anaplastic glioma stratum.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed malignant glioma - Recurrent
glioblastoma - Anaplastic astrocytoma - Mixed anaplastic glioma For recurrent
glioblastoma: Required documented progression must include an increase in tumor size of at
least 25% or appearance of new lesion For anaplastic astrocytoma or mixed anaplastic
glioma: Must have measurable, contrast enhancing disease on postoperative CT or MRI scan
No postoperative radiation or chemotherapy If patients have received prior brachytherapy
or stereotactic radiosurgery, they must have confirmation of true progressive disease
rather than radiation necrosis by PET scanning or biopsy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Absolute neutrophil count
at least 1,800/mm3 Platelet count at least 125,000/mm3 Hemoglobin at least 9 g/dL
(transfusion allowed) Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2.0 times
upper limit of normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance
greater than 70 mL/min Cardiovascular: No uncontrolled arrhythmias or conduction defects
No unstable or newly diagnosed angina pectoris No New York Heart Association class II-IV
heart disease No congestive heart failure No major problems with edema (e.g., severe
Cushing's syndrome, residual leg swelling from deep-vein thrombosis) No recent coronary
artery disease No poorly controlled hypertension (diastolic greater than 110 mmHg and
systolic greater than 180 mmHg) Pulmonary: DLCO greater than 80% of expected value Other:
HIV negative No major psychiatric illness No other prior malignancy except adequately
treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately
treated stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been free of disease for 5 years Not pregnant
or nursing Adequate contraception required of all fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy:
No prior nitrosourea or temozolomide No more than 1 prior chemotherapy regimen allowed for
patients with glioblastoma At least 6 weeks since mitomycin or procarbazine and recovered
At least 4 weeks since other prior chemotherapy and recovered No other concurrent
chemotherapy Endocrine therapy: If receiving steroids, must be on a stable steroid dose
for at least 72 hours prior to study No other concurrent endocrine therapy Radiotherapy:
At least 6 weeks since radiotherapy No greater than 10-20% of marrow irradiated in prior
radiotherapy No other concurrent radiotherapy Surgery: Surgery allowed

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael Prados, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UCSF Medical Center at Parnassus


United States: Federal Government

Study ID:




Start Date:

January 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult mixed glioma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms



University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15213
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213