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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00002960
First received: November 1, 1999
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Metastatic Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer
Biological: recombinant adenovirus-p53 SCH-58500
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Study in Patients With Peritoneal Carcinomatosis Using SCH 58500 (rAd/p53) Administered by Single Intraperitoneal Instillation

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Enrollment: 59
Study Start Date: March 1997
Study Completion Date: July 2000
Primary Completion Date: July 2000 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00002960

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Chair: Jo Ann Horowitz, MD Schering-Plough
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00002960     History of Changes
Other Study ID Numbers: C95084, SPRI-I/C95-084, NCI-V97-1181
Study First Received: November 1, 1999
Last Updated: July 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Merck Sharp & Dohme Corp.:
recurrent ovarian epithelial cancer
malignant ascites
fallopian tube cancer
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Neoplastic Processes
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on August 21, 2014