Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251394
Status:
COMPLETED
Last Update Posted:
2010-01-29
First Post:
2005-11-08
Brief Title:
Study of Dynavaxs 1018 ISS Following Rituxan in Patients With B-Cell Follicular Lymphoma
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase 2 Open-Label Study of the Efficacy Safety and Tolerability of Dynavaxs Immunostimulatory Phosphorothiolate Oligodeoxyribonucleotide 1018 ISS Following Rituxan Rituximab Treatment in Patients With CD20 B-Cell Follicular Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2009-07
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:
The main purpose of this study is to determine the effects good and bad and the safety of Dynavaxs immunostimulatory phosphorothiolate oligodeoxyribonucleotide 1018 ISS given in combination with Rituxan on patients with B-cell follicular non-Hodgkins lymphoma This research is being done because recurrent follicular non-Hodgkins lymphoma is not curable with standard chemotherapy or antibody treatments 1018 ISS is an experimental compound that consists of short pieces of DNA that stimulate the immune system It is hoped that 1018 ISS may improve the ability of Rituxan to kill cancer cells
Detailed Description:
Patients will receive four weekly infusions of Rituxan which is standard treatment for B-cell non-Hodgkins lymphoma Approximately 30 to 60 minutes after the second third and fourth infusions of Rituxan the patient will receive up to 3 injections of 1018 ISS under the skin The number of injections will depend upon the patients weight One week after the last Rituxan infusion the patient will receive a fourth and final injection of 1018 ISS
After completion of the 5-week treatment period a physical examination and blood work will be performed The patient will also be examined to see if the tumor has gotten smaller bigger or stayed the same size and in the same places by either CT scan or MRI A bone marrow aspiration and biopsy will be done to examine any changes in bone marrow cells
The following tests will be performed to determine whether or not a patient is eligible to participate in this clinical study Bone marrow aspiration and biopsy lymph node biopsy skin biopsy standard x-ray tests x-rays CT scans MRI ultrasounds andor radioactive drug scans and blood work
While receiving treatment patients will have the following procedures done Physical examination once a week for 4 weeks blood testing for any changes in the blood blood chemistry and other blood components Patients will also be requested to keep a diary between each study visit to record any health changes or any over-the-counter medication or herbal preparation they may have taken
After completion of the 5-week treatment period a physical examination and blood work will be performed The patient will also be examined to see if the tumor has gotten smaller bigger or stayed the same size and in the same places by either CT scan or MRI A bone marrow aspiration and biopsy will be done to examine any changes in bone marrow cells
The following tests will be performed to determine whether or not a patient is eligible to participate in this clinical study Bone marrow aspiration and biopsy lymph node biopsy skin biopsy standard x-ray tests x-rays CT scans MRI ultrasounds andor radioactive drug scans and blood work
While receiving treatment patients will have the following procedures done Physical examination once a week for 4 weeks blood testing for any changes in the blood blood chemistry and other blood components Patients will also be requested to keep a diary between each study visit to record any health changes or any over-the-counter medication or herbal preparation they may have taken
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 |
|---|---|---|---|
| U10402 | None | None | None |
| R21 | None | None | None |