Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003079
Status:
COMPLETED
Last Update Posted:
2010-02-17
First Post:
2000-05-02
Brief Title:
Bryostatin 1 and High Dose Cytarabine in Treating Patients With Refractory or Relapsed Leukemia or Lymphoma
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase I Study of Bryostatin 1 NSC 339555 and High-Dose 1-Beta-D-Arabinofuranosylcytosine HiDAC in Patients With Refractory Leukemia
Status:
COMPLETED
Status Verified Date:
2010-02
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase I trial to study the effectiveness of bryostatin 1 and high dose cytarabine in treating patients with refractory or relapsed acute myelocytic or acute lymphocytic leukemia chronic myelogenous leukemia or refractory or relapsed lymphoblastic lymphoma
PURPOSE Phase I trial to study the effectiveness of bryostatin 1 and high dose cytarabine in treating patients with refractory or relapsed acute myelocytic or acute lymphocytic leukemia chronic myelogenous leukemia or refractory or relapsed lymphoblastic lymphoma
Detailed Description:
OBJECTIVES I Define the maximum tolerated dose MTD of bryostatin 1 administered before and after high dose cytarabine in patients with refractory or relapsed acute myelocytic leukemia or acute lymphocytic leukemia chronic myelogenous leukemia or refractory or relapsed lymphoblastic lymphoma II Describe the toxic effects of bryostatin 1 and high dose cytarabine in these patients III Describe the time course of bryostatin 1 induced modulation of leukemic blast total protein kinase C PKC activity IV Describe bryostatin 1 pharmacokinetics V Correlate bryostatin 1 induced modulation of leukemic cell PKC activity or leukemic cell maturation with high dose cytarabine mediated apoptosis
OUTLINE This is a dose escalation study Patients receive bryostatin 1 by continuous infusion over 24 hours on day 1 One hour after completion of bryostatin 1 patients receive high dose cytarabine IV over 3 hours every 12 hours on days 2-4 Patients again receive cytarabine over 3 hours every 12 hours on days 9-11 followed 1 hour later by bryostatin 1 by continuous infusion over 24 hours beginning on day 11 Patients achieving complete remission may receive up to 4 courses of consolidation chemotherapy Consolidation chemotherapy is the same as induction chemotherapy except patients receive only 2 doses of cytarabine after day 1 completion of bryostatin and only 2 doses of cytarabine prior to the day 11 dose of bryostatin Patients achieving partial remission may receive a second course of induction chemotherapy In the absence of dose limiting toxicity in the first 3 patients treated subsequent cohorts of 6 patients receive escalating doses of bryostatin 1 on the same schedule If dose limiting toxicity occurs in 2 of 6 patients at a given dose level then dose escalation ceases and the current dose is defined as the maximum tolerated dose Patients are followed every 6 months until death
PROJECTED ACCRUAL A total of 12-50 patients will be accrued for this study
OUTLINE This is a dose escalation study Patients receive bryostatin 1 by continuous infusion over 24 hours on day 1 One hour after completion of bryostatin 1 patients receive high dose cytarabine IV over 3 hours every 12 hours on days 2-4 Patients again receive cytarabine over 3 hours every 12 hours on days 9-11 followed 1 hour later by bryostatin 1 by continuous infusion over 24 hours beginning on day 11 Patients achieving complete remission may receive up to 4 courses of consolidation chemotherapy Consolidation chemotherapy is the same as induction chemotherapy except patients receive only 2 doses of cytarabine after day 1 completion of bryostatin and only 2 doses of cytarabine prior to the day 11 dose of bryostatin Patients achieving partial remission may receive a second course of induction chemotherapy In the absence of dose limiting toxicity in the first 3 patients treated subsequent cohorts of 6 patients receive escalating doses of bryostatin 1 on the same schedule If dose limiting toxicity occurs in 2 of 6 patients at a given dose level then dose escalation ceases and the current dose is defined as the maximum tolerated dose Patients are followed every 6 months until death
PROJECTED ACCRUAL A total of 12-50 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-T97-0011 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016059 |
| P30CA016059 | NIH | None | None |
| MCV-MCC-9612-2E | None | None | None |