Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003039
Status:
COMPLETED
Last Update Posted:
2013-02-05
First Post:
1999-11-01
Brief Title:
Flavopiridol in Treating Patients With Recurrent Intermediate-Grade or High-Grade Non-Hodgkins Lymphoma or Mantle Cell Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Flavopiridol NSC 649890 Administered as a 72-Hour Continuous Infusion Every 2 Weeks in Patients With Previously Treated Intermediate and High Grade Non-Hodgkins Lymphoma Including Mantle Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2000-04
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 flavopiridol in treating patients with recurrent intermediate-grade or high-grade non-Hodgkins lymphoma or mantle cell lymphoma Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the objective response rate to flavopiridol by patients with previously treated intermediate and high grade non-Hodgkins lymphoma and mantle cell lymphoma
II Determine the toxicity of flavopiridol administered as a continuous infusion every 2 weeks in these patients
III Study the pharmacokinetics of flavopiridol in these patients
OUTLINE This is an open label multi-institutional study
Patients receive treatment on an outpatient basis Flavopiridol is administered as a continuous infusion over 72 hours every 2 weeks Patients receive a minimum of 4 cycles of therapy unless unacceptable toxicity or disease progression occurs Patients are followed until death
I Determine the objective response rate to flavopiridol by patients with previously treated intermediate and high grade non-Hodgkins lymphoma and mantle cell lymphoma
II Determine the toxicity of flavopiridol administered as a continuous infusion every 2 weeks in these patients
III Study the pharmacokinetics of flavopiridol in these patients
OUTLINE This is an open label multi-institutional study
Patients receive treatment on an outpatient basis Flavopiridol is administered as a continuous infusion over 72 hours every 2 weeks Patients receive a minimum of 4 cycles of therapy unless unacceptable toxicity or disease progression occurs Patients are followed until death
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 |
|---|---|---|---|
| UCCRC-8548 | None | None | None |
| NCI-T96-0099 | None | None | None |
| CDR0000065663 | REGISTRY | PDQ Physician Data Query | None |