Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002506
Status:
COMPLETED
Last Update Posted:
2011-05-12
First Post:
1999-11-01
Brief Title:
Isotretinoin Plus Interferon in Treating Patients With Recurrent Cancer
Sponsor:
Hoag Memorial Hospital Presbyterian
Organization:
Hoag Memorial Hospital Presbyterian
Study Overview
Official Title:
ALPHA INTERFERON AND CIS-RETINOIC ACID FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMAS
Status:
COMPLETED
Status Verified Date:
2011-05
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 Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer The use of isotretinoin may be an effective way to prevent cancer or stop cancer from growing Interferon alfa may interfere with the growth of cancer cells Combining isotretinoin and interferon may be an effective treatment for some recurrent cancers
PURPOSE Phase II trial to study the effectiveness of interferon alfa plus isotretinoin in treating patients with recurrent cancer
PURPOSE Phase II trial to study the effectiveness of interferon alfa plus isotretinoin in treating patients with recurrent cancer
Detailed Description:
OBJECTIVES I Determine the response rates to treatment with daily subcutaneous interferon alpha plus oral isotretinoin in patients with advanced squamous cell carcinomas of the following body sites head and neck cervix skin esophagus lung and penis II Determine the toxicities and side effects of this treatment
OUTLINE Nonrandomized study Single-agent Chemotherapy with Biological Response Modifier Therapy Isotretinoin 13-CRA NSC-329481 with Interferon alpha Schering or Hoffmann-La Roche IFN-A NSC-377523 or NSC-367982
PROJECTED ACCRUAL 14-50 patients per tumor category and any other tumor location if available will be enrolled If none of the first 14 patients in any tumor category responds or if only 122 230 337 444 or 550 respond the treatment will be considered ineffective for that tumor type
OUTLINE Nonrandomized study Single-agent Chemotherapy with Biological Response Modifier Therapy Isotretinoin 13-CRA NSC-329481 with Interferon alpha Schering or Hoffmann-La Roche IFN-A NSC-377523 or NSC-367982
PROJECTED ACCRUAL 14-50 patients per tumor category and any other tumor location if available will be enrolled If none of the first 14 patients in any tumor category responds or if only 122 230 337 444 or 550 respond the treatment will be considered ineffective for that tumor type
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-V92-0159 | None | None | None |
| CBRG-9208 | None | None | None |
| NBSG-9208 | None | None | None |