Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004902
Status:
COMPLETED
Last Update Posted:
2012-05-30
First Post:
2000-03-07
Brief Title:
Tocladesine in Treating Patients With Recurrent or Refractory Multiple Myeloma
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Pilot Evaluation of Infusional 8 Cl-cAMP in the Treatment of Relapsed or Refractory Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2012-05
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
PURPOSE Phase II trial to study the effectiveness of tocladesine in treating patients who have recurrent or refractory multiple myeloma
PURPOSE Phase II trial to study the effectiveness of tocladesine in treating patients who have recurrent or refractory multiple myeloma
Detailed Description:
OBJECTIVES I Determine the safety of 8-chloro-cyclic adenosine monophosphate 8-chloro-cAMP in patients with recurrent or refractory multiple myeloma II Evaluate the efficacy of this regimen in these patients III Determine the pharmacokinetics of this regimen in these patients
OUTLINE Patients receive 8-chloro-cyclic adenosine monophosphate 8-chloro-cAMP over 120 hours every 2 weeks for up to 4 courses Beginning with course 5 patients with stable or responsive disease receive 8-chloro-cAMP over 120 hours every 3 weeks until disease progression Patients are followed every 3 months until death
PROJECTED ACCRUAL A maximum of 29 patients will be accrued for this study within 12-18 months
OUTLINE Patients receive 8-chloro-cyclic adenosine monophosphate 8-chloro-cAMP over 120 hours every 2 weeks for up to 4 courses Beginning with course 5 patients with stable or responsive disease receive 8-chloro-cAMP over 120 hours every 3 weeks until disease progression Patients are followed every 3 months until death
PROJECTED ACCRUAL A maximum of 29 patients will be accrued for this study within 12-18 months
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 |
|---|---|---|---|
| NU-97H4 | None | None | None |
| NCI-G00-1681 | None | None | None |