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

Primary Purpose

Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
recombinant adenovirus-p53 SCH-58500
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, malignant ascites, fallopian tube cancer, primary peritoneal cavity cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    November 1, 1999
    Last Updated
    February 3, 2016
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00002960
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1999 (undefined)
    Primary Completion Date
    July 2000 (Actual)
    Study Completion Date
    July 2000 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
    Keywords
    recurrent ovarian epithelial cancer, malignant ascites, fallopian tube cancer, primary peritoneal cavity cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Enrollment
    59 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    recombinant adenovirus-p53 SCH-58500

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jo Ann Horowitz, MD
    Organizational Affiliation
    Schering-Plough
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    12082456
    Citation
    Buller RE, Shahin MS, Horowitz JA, Runnebaum IB, Mahavni V, Petrauskas S, Kreienberg R, Karlan B, Slamon D, Pegram M. Long term follow-up of patients with recurrent ovarian cancer after Ad p53 gene replacement with SCH 58500. Cancer Gene Ther. 2002 Jul;9(7):567-72. doi: 10.1038/sj.cgt.7700473.
    Results Reference
    result
    PubMed Identifier
    12082455
    Citation
    Buller RE, Runnebaum IB, Karlan BY, Horowitz JA, Shahin M, Buekers T, Petrauskas S, Kreienberg R, Slamon D, Pegram M. A phase I/II trial of rAd/p53 (SCH 58500) gene replacement in recurrent ovarian cancer. Cancer Gene Ther. 2002 Jul;9(7):553-66. doi: 10.1038/sj.cgt.7700472.
    Results Reference
    result

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

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