Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003166
Status:
COMPLETED
Last Update Posted:
2013-01-11
First Post:
1999-11-01
Brief Title:
Bryostatin and Vincristine in B-Cell Malignancies
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Combination Bryostatin 1 NSC 339555 and Vincristine in B-Cell Malignancies
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase I trial is studying the side effects and best dose of bryostatin-1 when given together with vincristine in treating patients with chronic lymphocytic leukemia non-Hodgkins lymphoma or multiple myeloma 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
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose of bryostatin 1 as a 24 hour infusion and vincristine when administered sequentially
II To determine the effect of this combination on programmed cell death apoptosis
III To determine the immunomodulatory effect of bryostatin 1 IV To observe patients for clinical antitumor response after giving combination bryostatin 1 and vincristine
OUTLINE This is a dose-escalation study of bryostatin 1
Patients receive bryostatin 1 IV over 24 hours followed immediately by vincristine IV Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity Patients completing 6 courses of therapy may receive subsequent courses every 3 weeks and then every 4 weeks after 24 months of treatment Patients may return to a 2- or 3-week treatment course at the discretion of the principal investigator
Cohorts of 3 patients receive escalating doses of bryostatin 1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 1 of 3 patients experience dose-limiting toxicity
Patients are followed every 3 months
I To determine the maximum tolerated dose of bryostatin 1 as a 24 hour infusion and vincristine when administered sequentially
II To determine the effect of this combination on programmed cell death apoptosis
III To determine the immunomodulatory effect of bryostatin 1 IV To observe patients for clinical antitumor response after giving combination bryostatin 1 and vincristine
OUTLINE This is a dose-escalation study of bryostatin 1
Patients receive bryostatin 1 IV over 24 hours followed immediately by vincristine IV Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity Patients completing 6 courses of therapy may receive subsequent courses every 3 weeks and then every 4 weeks after 24 months of treatment Patients may return to a 2- or 3-week treatment course at the discretion of the principal investigator
Cohorts of 3 patients receive escalating doses of bryostatin 1 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 1 of 3 patients experience dose-limiting toxicity
Patients are followed every 3 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 |
|---|---|---|---|
| CWRU 3Y97 | None | None | None |
| U01CA062502 | NIH | None | httpsreporternihgovquickSearchU01CA062502 |