Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002960
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
1999-11-01
Brief Title:
SCH-58500 in Treating Patients With Primary Ovarian Fallopian Tube or Peritoneal Cancer C95084
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Phase I Study in Patients With Peritoneal Carcinomatosis Using SCH 58500 rAdp53 Administered by Single Intraperitoneal Instillation
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V97-1181 | None | None | None |
| SPRI-IC95-084 | None | None | None |