Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024687
Status:
WITHDRAWN
Last Update Posted:
2014-11-14
First Post:
2001-09-24
Brief Title:
Study of SS1dsFv-PE38 SS1P Anti-Mesothelin Immunotoxin in Advanced Malignancies IV Infusion QOD x Six Doses
Sponsor:
INSYS Therapeutics Inc
Organization:
INSYS Therapeutics Inc
Study Overview
Official Title:
None
Status:
WITHDRAWN
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Support withdrawn - Study continued by NCI - see record NCT00006981
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although Neopharm has terminated its sponsorship of this study it is continuing under the sponsorship of the NCI Please contact Raffit Hassan MD at 301-451-8742 for more information Also see the related NCI study Experimental Drug SS1dsFv-PE38 to Treat Cancer Study ID number 010011
SS1dsFv-PE38 is an oncology drug product containing a bacteria toxin fused to a high affinity disulfide stabilized antibody The fused protein retains cell killing activity but binds only to cells expressing mesothelin Tumors characterized by very high surface mesothelin expression include mesothelioma epithelial carcinomas of ovary and peritoneum and squamous cancers of cervix and upper aerodigestive tract including esophagus head and neck cancers
This is a dose-escalating study to determine the maximum tolerated dose MTD of intravenous SS1dsFv-PE38 administered once every other day for six doses Dose escalation will proceed in cohorts of 3 until dose-limiting toxicity DLT is observed
SS1dsFv-PE38 is an oncology drug product containing a bacteria toxin fused to a high affinity disulfide stabilized antibody The fused protein retains cell killing activity but binds only to cells expressing mesothelin Tumors characterized by very high surface mesothelin expression include mesothelioma epithelial carcinomas of ovary and peritoneum and squamous cancers of cervix and upper aerodigestive tract including esophagus head and neck cancers
This is a dose-escalating study to determine the maximum tolerated dose MTD of intravenous SS1dsFv-PE38 administered once every other day for six doses Dose escalation will proceed in cohorts of 3 until dose-limiting toxicity DLT is observed
Detailed Description:
OBJECTIVES I Determine the toxicities and maximum tolerated dose MTD of six doses of SS1dsFv-PE38 QOD administered by intravenous infusion to patients with advanced malignancies
II Characterize the plasma pharmacokinetics of SS1dsFv-PE38 after intravenous infusion
III Determine toxicities attributable to subsequent courses of SS1dsFv-PE38
IV Evaluate the response of selected advanced malignancies to intravenous infusion of six doses of SS1dsFv-PE38 QOD administered at the MTD
V Determine the induction of antibody against SS1dsFv-PE38 and its relationship to pharmacokinetics
PROTOCOL OUTLINE To exclude immediate allergic hypersensitivity reaction each patient will receive a test dose of SS1dsFv-PE38 and be observed for 30 minutes prior to receiving study dosing Each treatment will be given by intravenous infusion over 30 minutes every other day Hydration will be maintained Oral hydration may be adequate but intravenous hydration may be used at the Investigators discretion Patients will be observed for at least 4 hours after infusion on Day 1 of each treatment course to exclude immediate allergic reaction Treatment may be repeated for a maximum of two additional courses after 4 weeks if re-treatment criteria are met At least three patients will be accrued at each dose level Dose escalation within a patient will not be allowed
PROJECTED ACCRUAL Up to 30 patients
II Characterize the plasma pharmacokinetics of SS1dsFv-PE38 after intravenous infusion
III Determine toxicities attributable to subsequent courses of SS1dsFv-PE38
IV Evaluate the response of selected advanced malignancies to intravenous infusion of six doses of SS1dsFv-PE38 QOD administered at the MTD
V Determine the induction of antibody against SS1dsFv-PE38 and its relationship to pharmacokinetics
PROTOCOL OUTLINE To exclude immediate allergic hypersensitivity reaction each patient will receive a test dose of SS1dsFv-PE38 and be observed for 30 minutes prior to receiving study dosing Each treatment will be given by intravenous infusion over 30 minutes every other day Hydration will be maintained Oral hydration may be adequate but intravenous hydration may be used at the Investigators discretion Patients will be observed for at least 4 hours after infusion on Day 1 of each treatment course to exclude immediate allergic reaction Treatment may be repeated for a maximum of two additional courses after 4 weeks if re-treatment criteria are met At least three patients will be accrued at each dose level Dose escalation within a patient will not be allowed
PROJECTED ACCRUAL Up to 30 patients
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