Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098436
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2004-12-07
Brief Title:
Temozolomide and VNP40101M in Treating Patients With Relapsed or Refractory Leukemias
Sponsor:
Vion Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study Of Cloretazine VNP40101M And Temozolomide In Patients With Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2008-08
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 such as temozolomide and VNP40101M work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Temozolomide may also help VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug Giving temozolomide together with VNP40101M may kill more cancer cells
PURPOSE This phase I trial is studying the side effects and best dose of temozolomide and VNP40101M in treating patients with relapsed or refractory leukemias
PURPOSE This phase I trial is studying the side effects and best dose of temozolomide and VNP40101M in treating patients with relapsed or refractory leukemias
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of temozolomide and VNP40101M in patients with relapsed or refractory leukemias
Determine the toxic effects of this regimen in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral temozolomide twice daily on days 1-3 for 5 doses followed by VNP401010M IV over 15-60 minutes on day 3 course 1 Patients achieving a complete or partial response or having 50 reduction in bone marrow blasts may receive a second course of therapy no earlier than day 43 Courses may be repeated approximately every 6 weeks at the discretion of the sponsor and in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of temozolomide until a dose that depletes leukemic blast AGT in at least 4 of 6 patients is determined Once this dose is determined cohorts of 3-6 patients receive escalating doses of VNP401010M 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 Up to 10 patients are treated at the MTD
PROJECTED ACCRUAL Approximately 25 patients will be accrued for this study
Determine the maximum tolerated dose of temozolomide and VNP40101M in patients with relapsed or refractory leukemias
Determine the toxic effects of this regimen in these patients
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral temozolomide twice daily on days 1-3 for 5 doses followed by VNP401010M IV over 15-60 minutes on day 3 course 1 Patients achieving a complete or partial response or having 50 reduction in bone marrow blasts may receive a second course of therapy no earlier than day 43 Courses may be repeated approximately every 6 weeks at the discretion of the sponsor and in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of temozolomide until a dose that depletes leukemic blast AGT in at least 4 of 6 patients is determined Once this dose is determined cohorts of 3-6 patients receive escalating doses of VNP401010M 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 Up to 10 patients are treated at the MTD
PROJECTED ACCRUAL Approximately 25 patients will be accrued for 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 |
|---|---|---|---|
| CWRU-050419 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000405825 | REGISTRY | None | None |