Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201669
Status:
COMPLETED
Last Update Posted:
2017-12-06
First Post:
2005-09-12
Brief Title:
A Phase II Study of Clofarabine in Patients With Aggressive Non-Hodgkins Lymphoma
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Clofarabine in Patients With Aggressive Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-12
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:
This study will determine the efficacy of clofarabine as measured by response rate in patients with aggressive non-Hodgkins lymphoma
Detailed Description:
Rationale Two Food and Drug Administration drugs approved for blood cancers such as non-Hodgkins lymphoma NHL include fludarabine Fludara and cladribine Leustat The drug offered in the current study clofarabine was designed to combine the anti-cancer strength of both fludarabine and cladribine Laboratory research suggests that clofarabine targets anti-cancer mechanisms in cells helps repair DNA and inhibits tumor growth Research also indicates that clofarabine has some efficacy against a variety of blood cancers and solid tumors Numerous tumor responses have been observed with high doses of clofarabine in heavily pretreated patients with different types of lymphoma The current study build on this previous research to test clofarabine in patients with aggressive NHL
Purpose This study will evaluate the safety and efficacy of clofarabine for aggressive NHL Toxicities resulting from the combination of clofarabine and the supportive care drug GM-CSF will also be analyzed in patients GM-CSF is a blood-forming agent that stimulates the production of white blood cells In addition several tests including blood and tumor tissue analysis will assess immune response and biological changes to the tumor as a result of study drugs
Treatment Patients in this study will be given clofarabine through intravenous infusions This drug will initially be provided to patients for five consecutive days Several tests will then be conducted and supportive care agents will be administered to stabilize patients blood cell counts immune response and reduce the risk of infection The first ten patients in this study will be hospitalized until recovery from the first five days of clofarabine to carefully monitor any additional toxicities resulting from the dosing regimen Patients will receive another five day treatment cycle with clofarabine within seven days after recovering from each previous cycle and no more than four weeks from the start of the previous cycle Disease response will be measured after every two cycles of treatment with clofarabine Patient with stable or reduced disease will receive a maximum of six treatment cycles with clofarabine Treatments will be discontinued due to disease growth unacceptable side effects or a treatment delay of more than 21 days
Purpose This study will evaluate the safety and efficacy of clofarabine for aggressive NHL Toxicities resulting from the combination of clofarabine and the supportive care drug GM-CSF will also be analyzed in patients GM-CSF is a blood-forming agent that stimulates the production of white blood cells In addition several tests including blood and tumor tissue analysis will assess immune response and biological changes to the tumor as a result of study drugs
Treatment Patients in this study will be given clofarabine through intravenous infusions This drug will initially be provided to patients for five consecutive days Several tests will then be conducted and supportive care agents will be administered to stabilize patients blood cell counts immune response and reduce the risk of infection The first ten patients in this study will be hospitalized until recovery from the first five days of clofarabine to carefully monitor any additional toxicities resulting from the dosing regimen Patients will receive another five day treatment cycle with clofarabine within seven days after recovering from each previous cycle and no more than four weeks from the start of the previous cycle Disease response will be measured after every two cycles of treatment with clofarabine Patient with stable or reduced disease will receive a maximum of six treatment cycles with clofarabine Treatments will be discontinued due to disease growth unacceptable side effects or a treatment delay of more than 21 days
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