Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00055640
Status:
COMPLETED
Last Update Posted:
2010-06-10
First Post:
2003-03-06
Brief Title:
Molecular Risk Assessment in Planning Treatment for Patients With Non-Hodgkins Lymphoma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2010-06
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 Analyzing genes that are present in cancer cells may be useful as a method for predicting the response of non-Hodgkins lymphoma to cancer treatment Imaging procedures such as positron emission tomography PET scans may improve the ability to measure how well cancer has responded to treatment
PURPOSE This phase II trial is studying molecular risk assessment to see how well it works in predicting response to therapy in patients who are receiving treatment for non-Hodgkins lymphoma
PURPOSE This phase II trial is studying molecular risk assessment to see how well it works in predicting response to therapy in patients who are receiving treatment for non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine whether molecular risk assessment can identify groups of patients with diffuse large B-cell non-Hodgkins lymphoma NHL who will demonstrate at least 50 difference in early response rates to treatment as determined by positron-emission tomography PET imaging
Determine by PET imaging the response rate of patients treated with cyclophosphamide doxorubicin vincristine prednisone and rituximab
Determine whether early response rates can be predicted by gene expression profiles at diagnosis in these patients
Compare gene expression profiles of patients with refractory or relapsed large cell NHL with profiles of the disease at diagnosis
Determine relapse-free and overall survival rates of these patients
Determine the feasibility of a new NHL treatment algorithm based on prognostic index and molecular risk and early response assessment by PET imaging
OUTLINE Molecular risk assessment is performed using lymph node tissue from initial diagnosis to test for activated genes before starting treatment
Patients receive rituximab IV over 3-6 hours cyclophosphamide IV over 30 minutes doxorubicin IV over 5 minutes and vincristine IV over 5 minutes on day 1 and oral prednisone on days 1-5 Treatment repeats every 21 days for 3-8 courses Patients undergo whole-body positron-emission tomography PET scanning at baseline and after course 3 to determine response Results from the genetic testing and PET scans are used to determine further treatment recommendations
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 36-50 patients will be accrued for this study
Determine whether molecular risk assessment can identify groups of patients with diffuse large B-cell non-Hodgkins lymphoma NHL who will demonstrate at least 50 difference in early response rates to treatment as determined by positron-emission tomography PET imaging
Determine by PET imaging the response rate of patients treated with cyclophosphamide doxorubicin vincristine prednisone and rituximab
Determine whether early response rates can be predicted by gene expression profiles at diagnosis in these patients
Compare gene expression profiles of patients with refractory or relapsed large cell NHL with profiles of the disease at diagnosis
Determine relapse-free and overall survival rates of these patients
Determine the feasibility of a new NHL treatment algorithm based on prognostic index and molecular risk and early response assessment by PET imaging
OUTLINE Molecular risk assessment is performed using lymph node tissue from initial diagnosis to test for activated genes before starting treatment
Patients receive rituximab IV over 3-6 hours cyclophosphamide IV over 30 minutes doxorubicin IV over 5 minutes and vincristine IV over 5 minutes on day 1 and oral prednisone on days 1-5 Treatment repeats every 21 days for 3-8 courses Patients undergo whole-body positron-emission tomography PET scanning at baseline and after course 3 to determine response Results from the genetic testing and PET scans are used to determine further treatment recommendations
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 36-50 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 |
|---|---|---|---|
| CWRU-1402 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-060244 | None | None | None |