SCH-58500 in Treating Patients With Primary Ovarian, Fallopian Tube, or Peritoneal Cancer (C95084)

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

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 Corp.

Study Sponsor

Jo Ann Horowitz, MD, Study Chair, Schering-Plough

Verification Date

February 2016