Ignite Creation Date:
2024-05-05 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002745
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-11-01
Brief Title:
Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkins Disease or Non-Hodgkins Lymphoma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE II STUDY OF 9-AMINOCAMPTOTHECIN 9-ACDMA NSC 603071 IN PREVIOUSLY TREATED HODGKINS DISEASE AND NON-HODGKINS LYMPHOMA IWF GRADES A-H
Status:
COMPLETED
Status Verified Date:
2013-01
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 aminocamptothecin in treating patients who have refractory or recurrent Hodgkins disease or non-Hodgkins lymphoma Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Evaluate the response rate and duration of response to aminocamptothecin 9-AC in patients with refractory or relapsed Hodgkins disease or non-Hodgkins lymphoma
II Assess the toxicity of 9-AC in these patients III Validate a preliminary pharmacodynamic model relating total 9-AC concentration albumin and bilirubin to toxicity
IV Determine whether 9-AC concentrations correlate with response
OUTLINE Patients are stratified by disease histology International Working Formulation IWF A-C vs IWF D-F and center
Patients receive aminocamptothecin IV continuously on days 1-3 Treatment repeats every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity Patients who achieve stable disease partial response PR or complete response CR may receive 2 additional courses past best response minimum of 6 courses if PR or CR Patients are followed every 6 months for 2 years and then annually thereafter
I Evaluate the response rate and duration of response to aminocamptothecin 9-AC in patients with refractory or relapsed Hodgkins disease or non-Hodgkins lymphoma
II Assess the toxicity of 9-AC in these patients III Validate a preliminary pharmacodynamic model relating total 9-AC concentration albumin and bilirubin to toxicity
IV Determine whether 9-AC concentrations correlate with response
OUTLINE Patients are stratified by disease histology International Working Formulation IWF A-C vs IWF D-F and center
Patients receive aminocamptothecin IV continuously on days 1-3 Treatment repeats every 2 weeks for a minimum of 3 courses in the absence of disease progression or unacceptable toxicity Patients who achieve stable disease partial response PR or complete response CR may receive 2 additional courses past best response minimum of 6 courses if PR or CR Patients are followed every 6 months for 2 years and then annually thereafter
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 |
|---|---|---|---|
| CDR0000064666 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CLB-9551 | None | None | None |