Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058305
Status:
COMPLETED
Last Update Posted:
2013-01-10
First Post:
2003-04-07
Brief Title:
Bryostatin 1 Plus Vincristine in Treating Patients With Progressive or Relapsed Non-Hodgkins Lymphoma After Bone Marrow or Stem Cell Transplantation
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Bryostatin 1 and Vincristine in Patients With Low or Intermediate Grade Non-Hodgkins Lymphoma Progressing or Relapsing After a Prior Autologous Bone Marrow or Stem Cell Transplant
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 II trial to study the effectiveness of combining bryostatin 1 with vincristine in treating patients who have progressive or relapsed non-Hodgkins lymphoma after autologous bone marrow transplantation or autologous stem cell transplantation Drugs used in chemotherapy such as vincristine 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 the cells more sensitive to the drug
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate response rate when bryostatin 1 is given in combination with vincristine in patients with low and intermediate grade non-Hodgkins lymphoma who have progressed or relapsed following an autologous bone marrow or stem cell transplant
II To determine if blunting of apoptotic response with two or more consecutive apoptotic fractions following treatment using annexin V staining of peripheral blood CD5 and CD19 lymphocytes by flow cytometry is predictive of outcome ie lack of clinical response
III To prospectively evaluate the incidence of grade 3 myelotoxicity with this regimen
OUTLINE This is a multicenter study
Patients receive bryostatin 1 IV over 24 hours on days 1 and 15 and vincristine IV on days 2 and 16 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients without disease progression after 6 courses may continue therapy with bryostatin 1 IV over 24 hours on days 1 and 22 and vincristine IV on days 2 and 23 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 2-5 years and then annually thereafter
I To evaluate response rate when bryostatin 1 is given in combination with vincristine in patients with low and intermediate grade non-Hodgkins lymphoma who have progressed or relapsed following an autologous bone marrow or stem cell transplant
II To determine if blunting of apoptotic response with two or more consecutive apoptotic fractions following treatment using annexin V staining of peripheral blood CD5 and CD19 lymphocytes by flow cytometry is predictive of outcome ie lack of clinical response
III To prospectively evaluate the incidence of grade 3 myelotoxicity with this regimen
OUTLINE This is a multicenter study
Patients receive bryostatin 1 IV over 24 hours on days 1 and 15 and vincristine IV on days 2 and 16 Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients without disease progression after 6 courses may continue therapy with bryostatin 1 IV over 24 hours on days 1 and 22 and vincristine IV on days 2 and 23 Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 2-5 years and then annually thereafter
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 |
|---|---|---|---|
| U01CA062502 | NIH | None | httpsreporternihgovquickSearchU01CA062502 |
| ICC 2402 | None | None | None |