Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004079
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
1999-12-10
Brief Title:
Sarcosinamide Nitrosourea in Treating Patients With Metastatic or Unresectable Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Sarcosinamide Nitrosourea SarCNU in Patients With Solid Tumors
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:
Phase I trial to study the effectiveness of sarcosinamide nitrosourea in treating patients who have metastatic or unresectable solid tumors Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the maximum tolerated dose MTD of an oral formulation of SarCNU given on an every 4th day times three schedule days 1 5 9
II Establish an appropriate oral dose of SarCNU for phase II clinical trials III Identify the dose-limiting toxicities DLTs of SarCNU IV Determine the oral bioavailability of SarCNU V Characterize the plasma pharmacokinetics of SarCNU
SECONDARY OBJECTIVES
I Determine whether SarCNU undergoes metabolic N-demethylation to generate reactive isocyanate species that have been implicated in BCNU pulmonary toxicity
II Evaluate response to treatment with SarCNU in patients with measurable or evaluable disease
III Attempt to establish pharmacodynamic relationships for response andor toxicity
OUTLINE This is a dose-escalation study
Patients receive oral sarcosinamide nitrosourea SarCNU on days 1 5 and 9 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SarCNU until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 4-5 weeks posttreatment
I Determine the maximum tolerated dose MTD of an oral formulation of SarCNU given on an every 4th day times three schedule days 1 5 9
II Establish an appropriate oral dose of SarCNU for phase II clinical trials III Identify the dose-limiting toxicities DLTs of SarCNU IV Determine the oral bioavailability of SarCNU V Characterize the plasma pharmacokinetics of SarCNU
SECONDARY OBJECTIVES
I Determine whether SarCNU undergoes metabolic N-demethylation to generate reactive isocyanate species that have been implicated in BCNU pulmonary toxicity
II Evaluate response to treatment with SarCNU in patients with measurable or evaluable disease
III Attempt to establish pharmacodynamic relationships for response andor toxicity
OUTLINE This is a dose-escalation study
Patients receive oral sarcosinamide nitrosourea SarCNU on days 1 5 and 9 Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of SarCNU until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed at 4-5 weeks posttreatment
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 |
|---|---|---|---|
| CDR0000067290 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062490 |
| 99-046 | None | None | None |
| U01CA062490 | NIH | None | None |