Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00389506
Status:
WITHDRAWN
Last Update Posted:
2012-03-16
First Post:
2006-10-18
Brief Title:
Fludarabine and Cyclophosphamide Followed By LMB-2 Immunotoxin in Treating Patients With Hodgkins Lymphoma
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Pilot Study of Anti-TacFv-PE38 LMB-2 Immunotoxin for Treatment of CD25 Positive Hodgkins Disease After Fludarabine and Cyclophosphamide
Status:
WITHDRAWN
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as fludarabine and cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing LMB-2 immunotoxin can find cancer cells and kill them without harming normal cells Giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin may kill more cancer cells
PURPOSE This clinical trial is studying how well giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin works in treating patients with Hodgkins lymphoma
PURPOSE This clinical trial is studying how well giving fludarabine and cyclophosphamide followed by LMB-2 immunotoxin works in treating patients with Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the feasibility of pretreatment with fludarabine phosphate and cyclophosphamide in preventing neutralization of antibodies in patients with CD25-positive Hodgkins lymphoma
Secondary
Determine the response rate in patients treated with LMB-2 immunotoxin
Determine the response duration in patients receiving this treatment
Correlate serum levels of LMB-2 immunotoxin with toxicity and response in these patients
Assess the development of neutralizing antibodies and the effect of these antibodies on blood levels of LMB-2 immunotoxin and toxicity
Correlate soluble Tac-peptide levels with treatment response in these patients
OUTLINE This is a nonrandomized pilot study
Patients receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-4 and filgrastim G-CSF subcutaneously once daily beginning on day 5 and continuing until blood counts recover
Beginning 4 weeks after completion of chemotherapy patients receive LMB-2 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression
Blood is obtained prior to and after chemotherapy and then periodically during LMB-2 immunotoxin therapy for pharmacokinetic studies to measure lymphocyte subsets
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the feasibility of pretreatment with fludarabine phosphate and cyclophosphamide in preventing neutralization of antibodies in patients with CD25-positive Hodgkins lymphoma
Secondary
Determine the response rate in patients treated with LMB-2 immunotoxin
Determine the response duration in patients receiving this treatment
Correlate serum levels of LMB-2 immunotoxin with toxicity and response in these patients
Assess the development of neutralizing antibodies and the effect of these antibodies on blood levels of LMB-2 immunotoxin and toxicity
Correlate soluble Tac-peptide levels with treatment response in these patients
OUTLINE This is a nonrandomized pilot study
Patients receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-4 and filgrastim G-CSF subcutaneously once daily beginning on day 5 and continuing until blood counts recover
Beginning 4 weeks after completion of chemotherapy patients receive LMB-2 immunotoxin IV over 30 minutes on days 1 3 and 5 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression
Blood is obtained prior to and after chemotherapy and then periodically during LMB-2 immunotoxin therapy for pharmacokinetic studies to measure lymphocyte subsets
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| CDR0000508789 | None | None | None |
| 06-C-0240 | None | None | None |
| NCI-P6761 | None | None | None |
| NCI-7835 | None | None | None |