Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014261
Status:
COMPLETED
Last Update Posted:
2018-03-30
First Post:
2001-04-10
Brief Title:
Temozolomide Plus PEG-Interferon Alfa-2B in Treating Patients With Advanced Solid Tumors
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
A Phase-I Study Of Cyclical Oral Administration Of Temozolomide In Combination With PEG12000-Interferon Alfa-2B In Patients With Refractory AndOr Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2018-03
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 PEG-interferon alfa-2B may interfere with the growth of cancer cells Combining temozolomide with PEG-interferon alfa-2B may be an effective treatment for advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combining temozolomide and PEG-interferon alfa-2B in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of combining temozolomide and PEG-interferon alfa-2B in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES
Determine the safety and tolerability of temozolomide and PEG-interferon alfa-2b in patients with advanced refractory solid tumors or chemotherapy-naive advanced cancer
Determine the maximum tolerated dose MTD and dose-limiting toxicity of this regimen in this patient population
Determine the pharmacokinetics of PEG-interferon alfa-2b at the MTD when administered with temozolomide in this patient population
Determine the anti-tumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oral temozolomide on days 1-7 and 15-21 and PEG-interferon alfa-2b subcutaneously on days 1 8 15 and 22 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-9 patients receive escalating doses of temozolomide and PEG-interferon alfa-2b until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for this study
Determine the safety and tolerability of temozolomide and PEG-interferon alfa-2b in patients with advanced refractory solid tumors or chemotherapy-naive advanced cancer
Determine the maximum tolerated dose MTD and dose-limiting toxicity of this regimen in this patient population
Determine the pharmacokinetics of PEG-interferon alfa-2b at the MTD when administered with temozolomide in this patient population
Determine the anti-tumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive oral temozolomide on days 1-7 and 15-21 and PEG-interferon alfa-2b subcutaneously on days 1 8 15 and 22 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 1-9 patients receive escalating doses of temozolomide and PEG-interferon alfa-2b until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A maximum of 24 patients will be accrued for this study
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-G01-1924 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA023108 |
| P30CA023108 | NIH | None | None |
| DMS-0010 | None | None | None |