Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022555
Status:
COMPLETED
Last Update Posted:
2013-01-25
First Post:
2001-08-10
Brief Title:
Bryostatin 1 Plus Vincristine in Treating Patients With Recurrent or Refractory HIV-Related Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Trial of Combination Bryostatin-1 and Vincristine in HIV-Related B-cell Neoplasms
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:
Phase I trial to study the effectiveness of bryostatin 1 plus vincristine in treating patients who have recurrent or refractory lymphoma Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Bryostatin 1 may help vincristine kill more cancer cells by making them more sensitive to the drug
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of bryostatin 1 when administered with vincristine in patients with recurrent or refractory HIV-related B-cell lymphoma
II Determine the toxicity profile of this regimen in these patients III Determine the objective response and survival of these patients treated with this regimen
IV Determine the immunomodulatory effects of this regimen on interleukin-2 IL-2 IL-2 receptor and IL-6 cytokine levels in these patients
V Determine the effect of this regimen on CD4 lymphocyte count and HIV load in these patients
VI Determine the effect of this regimen on the human herpes virus-8 load in these patients with body cavity-based lymphoma
OUTLINE This is a multicenter dose-escalation study of bryostatin 1
Patients receive bryostatin 1 IV continuously on days 1 and 15 and vincristine IV over 5 minutes on days 2 and 16 Treatment continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 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 2 of 6 patients experience dose-limiting toxicity
I Determine the maximum tolerated dose of bryostatin 1 when administered with vincristine in patients with recurrent or refractory HIV-related B-cell lymphoma
II Determine the toxicity profile of this regimen in these patients III Determine the objective response and survival of these patients treated with this regimen
IV Determine the immunomodulatory effects of this regimen on interleukin-2 IL-2 IL-2 receptor and IL-6 cytokine levels in these patients
V Determine the effect of this regimen on CD4 lymphocyte count and HIV load in these patients
VI Determine the effect of this regimen on the human herpes virus-8 load in these patients with body cavity-based lymphoma
OUTLINE This is a multicenter dose-escalation study of bryostatin 1
Patients receive bryostatin 1 IV continuously on days 1 and 15 and vincristine IV over 5 minutes on days 2 and 16 Treatment continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 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 2 of 6 patients experience dose-limiting toxicity
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 |
|---|---|---|---|
| CDR0000068830 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA070019 |
| AMC-029 | None | None | None |
| U01CA070019 | NIH | None | None |