Brief Title
SCH-58500 in Treating Patients With Primary Ovarian, Fallopian Tube, or Peritoneal Cancer (C95084)
Official Title
A Phase I Study in Patients With Peritoneal Carcinomatosis Using SCH 58500 (rAd/p53) Administered by Single Intraperitoneal Instillation
Brief Summary
RATIONALE: Giving the p53 gene for ovarian, fallopian tube, or peritoneal cancer may inhibit
tumor growth. Giving the gene directly into the peritoneum may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of SCH-58500 in treating patients who have
recurrent or persistent primary ovarian, fallopian tube, or peritoneal cancer.
Detailed Description
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.
Study Phase
Phase 1
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
recombinant adenovirus-p53 SCH-58500
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
59
Start Date
June 1999
Completion Date
July 2000
Primary Completion Date
July 2000
Eligibility 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
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Jo Ann Horowitz, MD, ,
Administrative Informations
NCT ID
NCT00002960
Organization ID
C95084
Secondary IDs
SPRI-I/C95-084
Responsible Party
Sponsor
Study Sponsor
Merck Sharp & Dohme LLC
Study Sponsor
Jo Ann Horowitz, MD, Study Chair, Schering-Plough
Verification Date
February 2016