Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003257
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Gene Therapy in Treating Patients With Recurrent Head and Neck Cancer
Sponsor:
Aventis Pharmaceuticals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Multicenter Open Label Study to Evaluate Effectiveness and Safety of AdCMV-p53 Administered by Intra-Tumoral Injections in 39 Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck SCCHN
Status:
UNKNOWN
Status Verified Date:
2000-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 p53 into a persons tumor may improve the bodys ability to fight cancer or make the cancer more sensitive to chemotherapy
PURPOSE Phase II trial to study the effectiveness of gene therapy in treating patients who have recurrent head and neck cancer
PURPOSE Phase II trial to study the effectiveness of gene therapy in treating patients who have recurrent head and neck cancer
Detailed Description:
OBJECTIVES I Estimate the objective response rate of Ad5CMV-p53 in patients with recurrent squamous cell carcinoma of the head and neck II Evaluate the duration of response time to disease progression and overall survival of these patients after this treatment III Evaluate the effectiveness of Ad5CMV-p53 in reducing cancer morbidity pain assessment analgesic consumption and Karnofsky performance status IV Assess the quality of life of these patients receiving this treatment
OUTLINE This is a multicenter open label study All patients receive direct intratumoral injections of Ad5CMV-p53 on days 1 2 and 3 of each 4-week treatment course Patients are treated for at least 2 courses barring local disease progression or unacceptable adverse events patients with responding or stable disease receive a maximum of 12 courses Patients are evaluated for safety 4 weeks from the completion of the last treatment Quality of life is assessed before during and after treatment Patients are followed every 2 months for up to 18 months or until death
PROJECTED ACCRUAL A maximum of 39 patients will be accrued for this study
OUTLINE This is a multicenter open label study All patients receive direct intratumoral injections of Ad5CMV-p53 on days 1 2 and 3 of each 4-week treatment course Patients are treated for at least 2 courses barring local disease progression or unacceptable adverse events patients with responding or stable disease receive a maximum of 12 courses Patients are evaluated for safety 4 weeks from the completion of the last treatment Quality of life is assessed before during and after treatment Patients are followed every 2 months for up to 18 months or until death
PROJECTED ACCRUAL A maximum of 39 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 |
|---|---|---|---|
| NCI-V98-1394 | None | None | None |
| AVENTIS-T-202 | None | None | None |
| MCC-11653 | None | None | None |
| RP-T-202 | None | None | None |