Assessment of the Safety and Transduction Efficiency of SCH58500, An Adenoviral Vector p53 Delivery System, to Patients With Recurrent Malignant Brain Tumors

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven glioblastoma multiforme, anaplastic
astrocytoma, or anaplastic mixed glioma Progressive or recurrent disease following
radiotherapy (54-64 Gy) and/or chemotherapy Tumor recurrence must have anatomic
characteristics that allow safe and reasonable surgical intervention Measurable disease by
serial MR or CT imaging No Li-Fraumeni syndrome or known germline defect in p53 gene No
radiographically or surgically proven gliomatosis cerebri No tumors requiring immediate
excision due to impending neurologic decline

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count
at least 1,000/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 25% Hepatic:
Bilirubin less than 1.5 mg/dL SGOT and SGPT less than 2.5 times upper limit of normal
(ULN) PT or PTT no greater than ULN Renal: Creatinine no greater than 1.7 mg/dL
Cardiovascular: No uncontrolled hypertension No uncontrolled or unstable angina pectoris
No uncontrolled cardiac dysrhythmia Other: Not pregnant or nursing Negative pregnancy test
Fertile patients must use effective contraception during and for 6 months after study HIV
negative No other active malignancy within the past 5 years except curatively treated
basal or squamous cell skin cancer or carcinoma in situ of the cervix No uncontrolled or
serious concurrent infection or other serious medical illness that would preclude study
therapy No viral syndrome diagnosed within 2 weeks prior to study No other underlying
medical condition that would increase risk of study or obscure interpretation of adverse
results No active adenoviral infection

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
and recovered No concurrent biologic therapy Chemotherapy: See Disease Characteristics No
more than 1 prior chemotherapy regimen At least 3 weeks since prior chemotherapy (6 weeks
for nitrosoureas) and recovered No prior interstitial chemotherapy such as Gliadel wafer
implantation for present brain tumor No concurrent chemotherapy Endocrine therapy: At
least 3 weeks since prior hormonal therapy and recovered No concurrent hormonal therapy
Radiotherapy: See Disease Characteristics No prior brachytherapy for present brain tumor
At least 3 months since other prior radiotherapy and recovered No concurrent radiotherapy
Surgery: See Disease Characteristics No prior radiosurgery for present brain tumor At
least 3 weeks since other prior oncologic surgery No other concurrent oncologic surgery
Other: No other concurrent investigational drugs