Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002970
Status:
COMPLETED
Last Update Posted:
2013-07-02
First Post:
1999-11-01
Brief Title:
506U78 in Treating Patients With Refractory Hematologic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Compound 506U78 in Patients With Refractory T-Cell Malignancies-POGCCG Intergroup Study
Status:
COMPLETED
Status Verified Date:
2013-07
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 II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the response rate to compound 506U78 2-amino-9-b-D-arabinofuranosyl-6-methoxy-9H-purine administered as a 1 hour infusion daily for 5 days in patients with recurrent T-cell malignancies
II Determine the toxicities of compound 506U78 in this group of patients III Correlate the biochemical pharmacology of compound 506U78 eg ara-G nucleotides in leukemic blasts and CSF concentrations with clinical response
IV Determine the impact of compound 506U78 therapy on survival and duration of response of patients with recurrent T-cell malignancies
OUTLINE Patients are stratified according to disease characteristics Group 1 T-cell ALL or NHL in first relapse greater than 25 bone marrow blasts with or without concomitant extramedullary relapse other than CNS Group 2 T-cell ALL or NHL in second or later relapse greater than 25 bone marrow blasts with or without concomitant extramedullary relapse other than CNS Group 3 T-cell ALL or NHL with positive bone marrow and CSF greater than 5 bone marrow blasts and CNS 2 or 3 involvement Group 4 Extramedullary relapse and less than 25 blasts in the bone marrow excluding isolated CNS relapse
GROUP 1 Patients receive a 1 hour infusion of compound 506U78 daily for 5 days in the absence of neurologic toxicity The course repeats every 21 days If a first relapse T-cell ALL study of higher priority is not open then the patient may continue to receive the drug every 21 days for a maximum of 2 years provided that the patient has achieved a second complete response
GROUPS 2 and 4 Patients receive compound 506U78 every 21 days for a maximum of 2 years in the absence of disease progression After 3 courses a patient may be given CNS prophylaxis with triple intrathecal therapy TIT consisting of methotrexate cytarabine and hydrocortisone after consultation with study coordinator TIT should be given every 12 weeks
GROUP 3 Patients receive compound 506U78 every 21 days for a maximum of 2 years in the absence of disease progression TIT will be given on day 1 of weeks 1-4 6 9 and every 6 weeks for 12 weeks and then every 9 weeks thereafter This stratum is open
I Determine the response rate to compound 506U78 2-amino-9-b-D-arabinofuranosyl-6-methoxy-9H-purine administered as a 1 hour infusion daily for 5 days in patients with recurrent T-cell malignancies
II Determine the toxicities of compound 506U78 in this group of patients III Correlate the biochemical pharmacology of compound 506U78 eg ara-G nucleotides in leukemic blasts and CSF concentrations with clinical response
IV Determine the impact of compound 506U78 therapy on survival and duration of response of patients with recurrent T-cell malignancies
OUTLINE Patients are stratified according to disease characteristics Group 1 T-cell ALL or NHL in first relapse greater than 25 bone marrow blasts with or without concomitant extramedullary relapse other than CNS Group 2 T-cell ALL or NHL in second or later relapse greater than 25 bone marrow blasts with or without concomitant extramedullary relapse other than CNS Group 3 T-cell ALL or NHL with positive bone marrow and CSF greater than 5 bone marrow blasts and CNS 2 or 3 involvement Group 4 Extramedullary relapse and less than 25 blasts in the bone marrow excluding isolated CNS relapse
GROUP 1 Patients receive a 1 hour infusion of compound 506U78 daily for 5 days in the absence of neurologic toxicity The course repeats every 21 days If a first relapse T-cell ALL study of higher priority is not open then the patient may continue to receive the drug every 21 days for a maximum of 2 years provided that the patient has achieved a second complete response
GROUPS 2 and 4 Patients receive compound 506U78 every 21 days for a maximum of 2 years in the absence of disease progression After 3 courses a patient may be given CNS prophylaxis with triple intrathecal therapy TIT consisting of methotrexate cytarabine and hydrocortisone after consultation with study coordinator TIT should be given every 12 weeks
GROUP 3 Patients receive compound 506U78 every 21 days for a maximum of 2 years in the absence of disease progression TIT will be given on day 1 of weeks 1-4 6 9 and every 6 weeks for 12 weeks and then every 9 weeks thereafter This stratum is open
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 |
|---|---|---|---|
| U10CA098543 | NIH | None | httpsreporternihgovquickSearchU10CA098543 |
| P9673 | None | None | None |
| CCG-P9673 | None | None | None |
| POG-9673 | None | None | None |
| CDR0000065478 | None | None | None |