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Phase I Trial of Intraperitoneal Adenoviral p53 Gene Therapy in Patients With Advanced Recurrent or Persistent Ovarian Cancer

Phase 1
18 Years
Open (Enrolling)
Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

Phase I Trial of Intraperitoneal Adenoviral p53 Gene Therapy in Patients With Advanced Recurrent or Persistent Ovarian Cancer

OBJECTIVES: I. Determine the maximum tolerated dose and toxicities of intraperitoneal
adenoviral p53 gene therapy in patients with advanced, recurrent, or persistent ovarian
carcinoma. II. Evaluate the vector pharmacokinetics and biologic efficacy of gene transfer,
gene expression, and cell death in these patients. III. Determine the immunologic response
to therapy in these patients.

OUTLINE: This is a dose escalation study of adenoviral p53 gene therapy. Patients undergo
removal of ascites, if present, from the peritoneal cavity followed by a bolus infusion of
adenovirus p53 once a week for 3 consecutive weeks, followed by a 2 week rest. Treatment
continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients who experience palliative results with at least stable disease may continue
treatment weekly without the rest period. Cohorts of 3-6 patients are treated at each level
of adenovirus p53. The maximum tolerated dose is defined as the dose level below that at
which 2 of 6 patients experience dose limiting toxicity. Patients who receive the MTD
without unacceptable toxicity may continue to receive treatment on a weekly basis.

PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued over 16-18 months for this

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed invasive ovarian epithelial carcinoma or
primary peritoneal carcinoma at time of initial laparotomy No histologically confirmed
noninvasive ovarian malignancy or low malignant potential tumor or carcinomatosis from
other nonovarian or peritoneal sites At least three courses of first-line combination
chemotherapy (platinum and paclitaxel) with either persistent or recurrent disease If no
treatment with first-line paclitaxel, salvage paclitaxel failure must be documented prior
to eligibility Ascites that is cytologically positive for adenocarcinoma or gross evidence
of recurrent disease with ascites, or gross recurrent disease with abdominopelvic washing
cytologically positive for adenocarcinoma Adequate peritoneal distribution by Technetium
99 scan

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy:
Greater than 12 weeks Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at
least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5
mg/dL SGOT/SGPT no greater than 2.5 times normal No active hepatitis or chronic liver
failure Renal: Creatinine no greater than 2 mg/dL Other: Not HIV positive No concurrent
immunosuppressive disorders No active systemic infections or active peritonitis
Geographically available for follow-up Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior viral based gene therapy treatments
or p53 directed vaccines No other prior gene therapy Chemotherapy: See Disease
Characteristics At least 4 weeks since chemotherapy No concurrent chemotherapy Endocrine
therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy No concurrent
radiotherapy Surgery: At least 4 weeks since surgery, including surgery for a perforated
bowel, bowel anastamosis, colostomy, or ileostomy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Carolyn Y. Muller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of New Mexico Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 1998

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms



Simmons Cancer Center - Dallas Dallas, Texas  75235-9154