Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001570
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Study of Continuous Intravenous Infusion of PSC 833 and Vinblastine in Patients With Metastatic Renal Cancer
Status:
COMPLETED
Status Verified Date:
2000-01
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:
Bolus PSC 833 is administered on Day 1 simultaneously with initiation of 24 hour continuous infusion of PSC 833 followed by another continuous infusion lasting an additional 6 days To ensure the safety of a 7 day infusion of PSC 833 one patient is treated for 5 days and a second for 6 days before the first cohort is enrolled
Vinblastine is administered in escalating doses on days 2-5 At least 3 patients are entered at each dose level The MTD will be defined as the dose immediately below that at which 2 patients experience dose limiting toxicity
Treatment continues every 28 days
Vinblastine is administered in escalating doses on days 2-5 At least 3 patients are entered at each dose level The MTD will be defined as the dose immediately below that at which 2 patients experience dose limiting toxicity
Treatment continues every 28 days
Detailed Description:
The Phase I clinical trial of the combination of 120-hour continuous intravenous infusion of vinblastine with oral PSC 833 has shown activity in patients with advanced malignancies particularly renal cell cancer The MTD of vinblastine in combination with the oral drink solution of PSC 833 was determined to be 09 mgm2day for five days and 125 mgkg po q 12 hours for eight days respectively For the soft gel capsule formulation the MTD was determined to be 06 mgm2day vinblastine for five days and 4 mgkg po q 6 hours PSC 833 for eight days Ataxia was the dose limiting toxicity Of the 46 patients two complete remissions and one partial remission were seen among 29 patients with renal cell carcinoma
In this Phase I study patients with advanced renal carcinoma will be treated with escalating doses of vinblastine given as a 72 hour infusion starting at approximately 40 of the total standard dose A shorter infusion schedule of vinblastine was chosen since there is evidence in other cytotoxic combinations that PSC 833 increases the AUC and decreases the plasma clearance of chemotherapeutic agents by approximately twofold Cytochrome P 450 3A or CYP3A which is the major cytochrome enzyme in the metabolism of vinblastine and PSC 833 will be measured during the first and fourth cycle through an in vivo test using a single intravenous dose of midazolam a short-acting benzodiazepine Vinblastine and PSC 833 pharmacokinetics will be performed at the same time For patients with accessible lesions tumor biopsy will be requested
In this Phase I study patients with advanced renal carcinoma will be treated with escalating doses of vinblastine given as a 72 hour infusion starting at approximately 40 of the total standard dose A shorter infusion schedule of vinblastine was chosen since there is evidence in other cytotoxic combinations that PSC 833 increases the AUC and decreases the plasma clearance of chemotherapeutic agents by approximately twofold Cytochrome P 450 3A or CYP3A which is the major cytochrome enzyme in the metabolism of vinblastine and PSC 833 will be measured during the first and fourth cycle through an in vivo test using a single intravenous dose of midazolam a short-acting benzodiazepine Vinblastine and PSC 833 pharmacokinetics will be performed at the same time For patients with accessible lesions tumor biopsy will be requested
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 |
|---|---|---|---|
| 97-C-0074 | None | None | None |