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


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

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Trial Information

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


OBJECTIVES: I. Estimate the efficiency of tumor cell transduction with adenovirus p53
delivered stereotactically to patients with recurrent or progressive resectable glioblastoma
multiforme, anaplastic astrocytoma, or anaplastic mixed glioma. II. Determine the maximum
tolerated dose of adenovirus p53 delivered stereotactically and with craniotomy in these
patients. III. Correlate analysis of predelivery tumor specimen p53 gene status with
postdelivery p53 gene status, clinical status, and tumor staging in these patients treated
with this regimen. IV. Correlate analysis of postdelivery tumor specimen p53 gene status and
local tumor immune response with postdelivery clinical status and tumor imaging in these
patients treated with this regimen.

OUTLINE: This is a dose escalation, multicenter study. Patients receive SCH-58500 via
stereotactic injection into the tumor, followed 24-72 hours later by craniotomy. Patients
undergo tumor resection, followed by injection of SCH-58500 into the tumor bed during
craniotomy. Cohorts of 3-6 patients receive escalating doses of SCH-58500 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding
that at which 3 of 3-6 patients experience dose limiting toxicity. Patients are followed at
day 28, then every 2 months for 1 year, and then annually thereafter, until another therapy
is begun or disease progression is documented.

PROJECTED ACCRUAL: A total of 21-42 patients will be accrued for this study over 14-27
months.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jeffrey J. Olson, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Winship Cancer Institute of Emory University

Authority:

United States: Federal Government

Study ID:

CDR0000067291

NCT ID:

NCT00004080

Start Date:

December 1999

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
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

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