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A Phase I Study in Patients With Peritoneal Carcinomatosis Using SCH 58500 (rAd/p53) Administered by Single Intraperitoneal Instillation


Phase 1
18 Years
N/A
Not Enrolling
Female
Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

A Phase I Study in Patients With Peritoneal Carcinomatosis Using SCH 58500 (rAd/p53) Administered by Single Intraperitoneal Instillation


OBJECTIVES: I. Assess the safety of SCH-58500 (recombinant adenoviral vector containing p53
tumor suppressor gene) when given as a single or multiple intraperitoneal instillation in
combination with chemotherapy to patients with peritoneal carcinomatosis demonstrating p53
mutant ovarian, fallopian tube, or peritoneal carcinoma. II. Assess the biological activity
of SCH-58500 by confirming wild type p53 gene expression. III. Assess the stability of
SCH-58500 infection and expression by collection and analysis of serial, posttreatment,
ascites specimens in a subset of 5 patients. IV. Assess the pharmacokinetics of SCH-58500 by
serum and peritoneal fluid measurements. V. Document any clinical evidence of antitumor
activity in these patients treated with this regimen.

OUTLINE: This is an abbreviated dose escalation, multicenter study of SCH-58500. Patients
receive SCH-58500 by intraperitoneal instillation on days 1-5 (depending on dose level).
Patients undergo ascites fluid and tumor sampling before and after intraperitoneal
instillation. The ascitic fluid or tumor and normal tissue are then submitted for cytologic
or histopathologic examination and biological activity analysis. Cohorts of 3-6 patients
receive escalating doses of SCH-58500 until 3 patients experience dose limiting toxicity or
until the highest planned dose is reached. Patients are followed at 2 months, every 3 months
for 1 year, and then yearly thereafter.

PROJECTED ACCRUAL: A total of 6-60 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Radiographic or surgical evidence of primary ovarian, fallopian
tube, or peritoneal carcinoma Ascites cytologically positive for peritoneal carcinomatosis
from recurrent or persistent ovarian, fallopian tube, or peritoneal carcinoma Must have
ascites and tumor accessible by laparoscopic or percutaneous biopsy Immunohistochemical
evidence of p53 gene mutation in the ascitic fluid cell block or primary tumor biopsy or
other documented mutation

PATIENT CHARACTERISTICS: Age: 18 and over Life expectancy: At least 3 months Performance
status: Karnofsky 60-100% Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count
at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5
mg/dL AST/ALT less than 1.5 times the upper limit of normal (ULN) Alkaline phosphatase
less than 1.5 times ULN Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance
greater than 50 mL/min Other: Ability to tolerate paired paracenteses or biopsies
(percutaneous or laparoscopic) HIV negative No adenoviral infections determined by ELISA
screening No uncontrolled serious bacterial, viral, fungal or parasitic infection No known
or suspected hypersensitivity to study drug or any excipient used in formulation or
delivery system No underlying medical condition that would obscure interpretation of
adverse events Not pregnant or nursing Fertile patients must use effective contraception
for at least 1 month before, during, and 6 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 month since prior biologic therapy
and recovered Chemotherapy: At least 3 months since local intraperitoneal antitumor
therapy directed against peritoneal carcinomatosis and recovered At least 1 month since
systemic chemotherapy for ovarian, fallopian tube, or peritoneal cancer or an unapproved
indication and recovered Endocrine therapy: At least 3 months since any systemic
corticosteroid therapy Radiotherapy: At least 1 year since prior total abdominal
radiotherapy Surgery: Not specified Other: At least 3 months since prior investigational
therapy and recovered At least 3 months since prior immunosuppressive therapy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jo Ann Horowitz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Schering-Plough

Authority:

United States: Federal Government

Study ID:

CDR0000065438

NCT ID:

NCT00002960

Start Date:

January 1997

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Metastatic Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • malignant ascites
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242