Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006033
Status:
COMPLETED
Last Update Posted:
2013-05-30
First Post:
2000-07-05
Brief Title:
Interleukin-2 Gene or Methotrexate in Treating Patients With Recurrent or Refractory Stage III or Stage IV Head and Neck Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Protocol IL-2001 A Multi-Center Open-Label Randomized Study of the Efficacy and Safety of Multiple Intratumoral Injections of hIl-2 Plasmid 18 mg Formulated With DOTMACholesterol Ratio 105- Liposomes in Patients With Unresctable or RecurrentRefractory Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2001-01
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:
RATIONALE Inserting the gene for interleukin-2 into head and neck cancer cells may make the body build an immune response to kill the tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether the interleukin-2 gene is more effective than methotrexate for advanced head and neck cancer
PURPOSE Randomized phase II trial to compare the effectiveness of the interleukin-2 gene with that of methotrexate in treating patients who have recurrent or refractory stage III or stage IV head and neck cancer
PURPOSE Randomized phase II trial to compare the effectiveness of the interleukin-2 gene with that of methotrexate in treating patients who have recurrent or refractory stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES I Compare the efficacy of interleukin-2 gene versus methotrexate in patients with recurrent or refractory squamous cell carcinoma of the head and neck II Determine the safety and tolerability of interleukin-2 gene in these patients III Compare the quality of life of these patients
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive interleukin-2 gene intratumorally on days 1 and 4 of week 1 and then once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity Arm II Patients receive methotrexate IV once weekly Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at the beginning of the study and at weeks 5 13 17 and 25 Patients are followed every 2-3 weeks for up to 18 weeks
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive interleukin-2 gene intratumorally on days 1 and 4 of week 1 and then once weekly for 12 weeks in the absence of disease progression or unacceptable toxicity Arm II Patients receive methotrexate IV once weekly Treatment continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at the beginning of the study and at weeks 5 13 17 and 25 Patients are followed every 2-3 weeks for up to 18 weeks
PROJECTED ACCRUAL A total of 80 patients 40 per treatment arm 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 |
|---|---|---|---|
| NCI-G00-1810 | Registry Identifier | PDQ Physician Data Query | None |
| MCC-12051 | None | None | None |
| MCC-IRB-5482 | None | None | None |
| CDR0000068046 | REGISTRY | None | None |