Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003569
Status:
COMPLETED
Last Update Posted:
2013-01-31
First Post:
1999-11-01
Brief Title:
Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Phase I Trial of Escalating Doses of BNP7787 in Patients With Solid Tumors Undergoing Treatment With Cisplatin and Taxol
Status:
COMPLETED
Status Verified Date:
2013-01
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Chemoprotective drugs such as dimesna may protect normal cells from the side effects of chemotherapy
PURPOSE This phase I trial is studying the side effects and best dose of dimesna in treating patients with solid tumors who are receiving cisplatin and paclitaxel
PURPOSE This phase I trial is studying the side effects and best dose of dimesna in treating patients with solid tumors who are receiving cisplatin and paclitaxel
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose MTD of dimesna administered prior to cisplatin and paclitaxel in patients with solid tumors
Determine the dose related qualitative and quantitative side effects of dimesna administered on this schedule in these patients
Determine the minimum safe volume of intravenous hydration after the determination of the MTD of dimesna in these patients
Investigate the possible protective side effects of dimesna in reducing or preventing the development of cisplatin induced nephrotoxicity and observe possible protective effects against cisplatin or paclitaxel related neurotoxicity and myelosuppression in these patients
Investigate the pharmacokinetic behavior of dimesna in the plasma and urine on this schedule of administration in this patient population
OUTLINE This is a dose-escalation two-stage multicenter study
During stage I patients receive a single dose of dimesna IV over 15 minutes 7 days prior to chemotherapy Patients then receive paclitaxel IV over 3 hours followed by dimesna IV over 15-30 minutes followed immediately by cisplatin IV over 1 hour on day 1 every 3 weeks Patients continue courses of paclitaxel dimesna and cisplatin every 3 weeks in the absence of disease progression or unacceptable toxicity for up to 6 courses
In stage I cohorts of 3-6 patients each receive escalating doses of dimesna until the maximum tolerated dose MTD is reached The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose limiting toxicity DLT The MTD of dimesna is then used in stage II of the study in which the volume of pre and post cisplatin intravenous saline hydration is reduced in cohorts of 3-6 patients each The MTD intensity of cisplatin is defined as the least saline hydration volume at which no more than 1 of 6 patients experience DLT
PROJECTED ACCRUAL Approximately 35 patients will be accrued into this study
Determine the maximum tolerated dose MTD of dimesna administered prior to cisplatin and paclitaxel in patients with solid tumors
Determine the dose related qualitative and quantitative side effects of dimesna administered on this schedule in these patients
Determine the minimum safe volume of intravenous hydration after the determination of the MTD of dimesna in these patients
Investigate the possible protective side effects of dimesna in reducing or preventing the development of cisplatin induced nephrotoxicity and observe possible protective effects against cisplatin or paclitaxel related neurotoxicity and myelosuppression in these patients
Investigate the pharmacokinetic behavior of dimesna in the plasma and urine on this schedule of administration in this patient population
OUTLINE This is a dose-escalation two-stage multicenter study
During stage I patients receive a single dose of dimesna IV over 15 minutes 7 days prior to chemotherapy Patients then receive paclitaxel IV over 3 hours followed by dimesna IV over 15-30 minutes followed immediately by cisplatin IV over 1 hour on day 1 every 3 weeks Patients continue courses of paclitaxel dimesna and cisplatin every 3 weeks in the absence of disease progression or unacceptable toxicity for up to 6 courses
In stage I cohorts of 3-6 patients each receive escalating doses of dimesna until the maximum tolerated dose MTD is reached The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose limiting toxicity DLT The MTD of dimesna is then used in stage II of the study in which the volume of pre and post cisplatin intravenous saline hydration is reduced in cohorts of 3-6 patients each The MTD intensity of cisplatin is defined as the least saline hydration volume at which no more than 1 of 6 patients experience DLT
PROJECTED ACCRUAL Approximately 35 patients will be accrued into this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-DS-9739 | None | None | None |
| NCI-G98-1478 | None | None | None |
| BIONUM-BNP7787IV101 | None | None | None |