Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024674
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WITHDRAWN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 Continuous Infusion for 10 Days
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WITHDRAWN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Support withdrawn - Study continued by NCI - see record NCT00006981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 see 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 continuously for 10 days every four weeks for a maximum of four courses of treatment 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 continuously for 10 days every four weeks for a maximum of four courses of treatment Dose escalation will proceed in cohorts of 3 until dose-limiting toxicity DLT is observed
Detailed Description:
OBJECTIVES I Investigate the safety and efficacy of SS1dsFv-PE38 administered as a 10-day continuous intravenous infusion
II Determine the toxicities and maximum tolerated dose MTD of SS1dsFv-PE38 given by continuous intravenous infusion for ten days in patients with advanced malignancies
III Evaluate response of selected advanced malignancies to continuous intravenous infusion of SS1dsFv-PE38 for ten days at doses near the MTD
IV Characterize the plasma kinetics of SS1dsFv-PE38 administered by continuous intravenous infusion
V Determine the appearance of serum antibody to SS1dsFv-PE38
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 the continuous infusion on Day 1 of each treatment course Each treatment will be given by continuous intravenous infusion for ten days After the first 24 hours of infusion at the Investigators discretion patients will be allowed to leave the hospital on day pass per NCI policies After the end of infusion patients will be observed overnight The first patient at each dose level must be observed for development of toxicity for at least 14 days after the beginning of treatment before additional patients are enrolled 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 Determine the toxicities and maximum tolerated dose MTD of SS1dsFv-PE38 given by continuous intravenous infusion for ten days in patients with advanced malignancies
III Evaluate response of selected advanced malignancies to continuous intravenous infusion of SS1dsFv-PE38 for ten days at doses near the MTD
IV Characterize the plasma kinetics of SS1dsFv-PE38 administered by continuous intravenous infusion
V Determine the appearance of serum antibody to SS1dsFv-PE38
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 the continuous infusion on Day 1 of each treatment course Each treatment will be given by continuous intravenous infusion for ten days After the first 24 hours of infusion at the Investigators discretion patients will be allowed to leave the hospital on day pass per NCI policies After the end of infusion patients will be observed overnight The first patient at each dose level must be observed for development of toxicity for at least 14 days after the beginning of treatment before additional patients are enrolled 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI Study 01-C-0011 | None | None | None |