Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004864
Status:
COMPLETED
Last Update Posted:
2018-09-10
First Post:
2000-03-07
Brief Title:
Docetaxel and GEM 231 in Treating Patients With Recurrent or Refractory Solid Tumors
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
A Phase I Open-Label Safety Study of Escalating Doses of Taxotere in Combination With Escalating Doses of GEM231 in Patients With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2018-09
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Gene therapy such as GEM 231 may inhibit the growth of cancer cells and make the tumor more sensitive to chemotherapy
PURPOSE Phase I trial to study the effectiveness of combining docetaxel and GEM 231 in treating patients who have recurrent or refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of combining docetaxel and GEM 231 in treating patients who have recurrent or refractory solid tumors
Detailed Description:
OBJECTIVES I Determine the safety and maximum tolerated dose of docetaxel and GEM 231 in patients with recurrent or refractory solid tumors II Determine any preliminary antitumor activity of GEM 231 in this patient population
OUTLINE This is a dose escalation study of GEM 231 and docetaxel Patients receive docetaxel IV over 1 hour on day 1 immediately followed by GEM 231 IV over 2 hours on days 1 4 8 and 11 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated with escalating doses of GEM 231 and docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity Patients are followed monthly for 3 months
PROJECTED ACCRUAL A maximum of 1 patient will be accrued per week for this study until the maximum tolerated dose is reached
OUTLINE This is a dose escalation study of GEM 231 and docetaxel Patients receive docetaxel IV over 1 hour on day 1 immediately followed by GEM 231 IV over 2 hours on days 1 4 8 and 11 Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients are treated with escalating doses of GEM 231 and docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 2 of 6 patients experience dose limiting toxicity Patients are followed monthly for 3 months
PROJECTED ACCRUAL A maximum of 1 patient will be accrued per week for this study until the maximum tolerated dose is reached
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-G00-1666 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA013330 |
| P30CA013330 | NIH | None | None |
| AECM-1199906197 | None | None | None |
| HYBRIDON-231-100A | None | None | None |