Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003005
Status:
COMPLETED
Last Update Posted:
2012-06-13
First Post:
1999-11-01
Brief Title:
Chemotherapy With Cordycepin Plus Pentostatin in Treating Patients With Refractory Acute Lymphocytic or Chronic Myelogenous Leukemia
Sponsor:
Boston Medical Center
Organization:
Boston Medical Center
Study Overview
Official Title:
A Phase I Study of Cordycepin NSC 63984 Plus 2-Deoxycoformycin NSC 218321 in Patients With Refractory TdT-Positive Leukemia
Status:
COMPLETED
Status Verified Date:
2000-06
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 Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of chemotherapy consisting of cordycepin plus pentostatin in treating patients with refractory acute lymphocytic or chronic myelogenous leukemia
PURPOSE Phase I trial to study the effectiveness of chemotherapy consisting of cordycepin plus pentostatin in treating patients with refractory acute lymphocytic or chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Evaluate the safety maximum tolerated dose adverse effects and toxicities of cordycepin given 1 hour following a fixed dose of the adenosine deaminase inhibitor pentostatin in patients with refractory TdT positive leukemia II Determine the single and multiple dose pharmacokinetics of cordycepin given 1 hour following a fixed dose of pentostatin III Characterize selected whole blood and blast cell metabolic parameters serially in relation to cordycepinpentostatin administration IV Measure and quantify any clinical responses in refractory TdT positive leukemia patients following cordycepinpentostatin administration
OUTLINE This is a dose escalation study Each treatment course is 28 days in length On days 1-3 pentostatin is administered over 5 minutes by IV bolus and followed 1 hour later by a 1 hour infusion of cordycepin IV An escalating dose of pentostatin is given with a fixed dose of cordycepin until the desired level of adenosine deaminase inhibition is observed After this is determined a dose escalation schedule for cordycepin is initiated to determine the maximum tolerated dose MTD when given in combination with pentostatin The MTD is determined by the number of patients who exhibit dose limiting toxicity and the severity of the toxicity
PROJECTED ACCRUAL Approximately 30 patients will be accrued
OUTLINE This is a dose escalation study Each treatment course is 28 days in length On days 1-3 pentostatin is administered over 5 minutes by IV bolus and followed 1 hour later by a 1 hour infusion of cordycepin IV An escalating dose of pentostatin is given with a fixed dose of cordycepin until the desired level of adenosine deaminase inhibition is observed After this is determined a dose escalation schedule for cordycepin is initiated to determine the maximum tolerated dose MTD when given in combination with pentostatin The MTD is determined by the number of patients who exhibit dose limiting toxicity and the severity of the toxicity
PROJECTED ACCRUAL Approximately 30 patients will be accrued
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 |
|---|---|---|---|
| BUMC-4266 | None | None | None |
| NCI-T96-0051 | None | None | None |