Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00333008
Status:
UNKNOWN
Last Update Posted:
2006-09-26
First Post:
2006-05-31
Brief Title:
A Dose Study of Doxil in a Dose Dense 14 Day CDOPRituximab Regimen for Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma NHL 60 Years or With Compromised Cardiac Status
Sponsor:
The Alvin and Lois Lapidus Cancer Institute
Organization:
The Alvin and Lois Lapidus Cancer Institute
Study Overview
Official Title:
Phase II Dose Study of Doxil in a Dose Dense 14 Day CDOPRituximab Regimen for Patients With Diffuse Large B-Cell NHL 60 Years or With Compromised Cardiac Status
Status:
UNKNOWN
Status Verified Date:
2006-09
Last Known Status:
RECRUITING
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 purpose of this study is to evaluate the feasibility and tolerability of delivering a full dose on time schedule of dose-dense CDOP-R cyclophosphamide doxil vincristine prednisone and rituximab in NHL
Detailed Description:
Diffuse large B-cell lymphoma DLBCL is the most frequent type of non-Hodgkins lymphoma with more than half of the patients being over the age of 60 years Elderly patients with cancer are defined by the American Society of Clinical Oncology as a special population due to their disease characteristics additional health problems and need for aggressive supportive care strategies to reduce morbidity and mortality The combination of cyclophosphamide doxorubicin vincristine and prednisone CHOP remains as standard therapy for the treatment of DLBCL but elderly patients tend to tolerate the CHOP therapy less when compared to younger patients Cardiac toxicity as well as decrease in blood counts are the most common side effects in the elderly population For these reasons many doctors are reluctant to use standard combinations and doses of chemotherapy in the elderly for fear of increased morbidity DLBCL in the elderly is also somewhat unique in that the elderly patients appear to have more aggressive disease and poor overall outcome In order to maximize the tolerability of treatment and thus potentially enhance overall treatment success in this population it is necessary to look at alternative treatments This clinical trial is based on currently accepted standard NHL therapy CHOP-Rituximab in which Doxil is substituted for Adriamycin Growth factor will be used for support of acceptable blood counts Chemotherapy regimens that include rituximab are now the gold standard for treatment of DLBCL If indeed delivering full dose chemotherapy without treatment delays leads to higher remission and cure rates then this offers a significant proportion of NHL patients who are elderly a chance for cure rather than providing treatment for comfort measures while preserving quality of life
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