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Phase I Trial of Adenovirus-Mediated Wild-Type P53 Gene Therapy for Malignant Gliomas

Phase 1
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

Phase I Trial of Adenovirus-Mediated Wild-Type P53 Gene Therapy for Malignant Gliomas

OBJECTIVES: I. Determine the biological effects at the molecular level of intratumoral
administration of adenovirus p53 gene (Ad-p53) in patients with malignant primary glioma.
II. Determine the maximum tolerated dose of intratumoral Ad-p53 in these patients. III.
Evaluate the qualitative and quantitative toxicity of intratumoral Ad-p53 in this patient

OUTLINE: This is a dose-escalation, multicenter study. Patients receive an initial
intratumoral stereotactic injection of adenovirus p53 (Ad-p53) over 10 minutes on day 1. In
the absence of unacceptable toxicity resulting from this initial injection, patients then
undergo tumor resection and receive a series of 1-minute injections of Ad-p53 into the
resected tumor cavity wall on day 4. Cohorts of 3-6 patients receive escalating doses of
Ad-p53. If 2 of 3 or 3 of 6 patients experience dose limiting toxicity (DLT) at a particular
dose level, escalation ceases and the maximum tolerated dose is defined as the previous dose
level. Patients are followed closely for 12 weeks, then every 2 weeks for 8 weeks, then
every 4 weeks for 8 weeks, and then every 8 weeks until death.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven malignant primary glioma Glioblastoma
multiforme Anaplastic oligodendroglioma Gliosarcoma Mixed malignant glioma Anaplastic
astrocytoma Clear evidence of tumor recurrence or progression by CT or MRI within 2 weeks
prior to study after failing prior best surgical resection and radiation Surgically
accessible tumor for which resection is indicated Tumors greater than 2.0 cm in diameter
Tumor not extending into the ventricular system

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life
expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm3
Platelet count at least 100,000/mm3 No evidence of bleeding diatheses Hepatic: SGPT no
greater than 2 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2
times ULN Bilirubin less than 1.5 mg/dL Renal: BUN less than 1.5 times ULN OR Creatinine
less than 1.5 times ULN Cardiovascular: Not specified Pulmonary: Not specified Other: No
active uncontrolled infection Must be afebrile (less than 38.0 degrees Celsius) No other
unstable or serious medical conditions HIV negative Not pregnant or nursing Fertile
patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy
allowed (at least 2 weeks since prior vincristine, 3 weeks since prior procarbazine, and 6
weeks since prior nitrosoureas) and recovered Endocrine therapy: Not specified
Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy
Surgery: See Disease Characteristics Other: No prior or concurrent anticoagulants

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Frederick F. Lang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:




Start Date:

March 1999

Completion Date:

Related Keywords:

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