Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001296
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan Tumor Necrosis Factor and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Randomized Phase III Trial of Hyperthermic Isolated Limb Perfusion With Melphalan Tumor Necrosis Factor and Interferon-Gamma in Patients With Locally Advanced Extremity Melanoma
Status:
COMPLETED
Status Verified Date:
1999-11
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:
Randomized study Initially 3 patients will be entered on Arm I as a pilot feasibility study and to standardize the technical aspects of the study Subsequently all patients are randomized to Arms I and II
Arm I Regional Hyperthermia plus Regional Single-Agent Chemotherapy Hyperthermic intravenous limb perfusion HILP plus Melphalan L-PAM NSC-8806
Arm II Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response Modifier Therapy HILP as in Arm I plus L-PAM and Tumor Necrosis Factor Knoll TNF NSC-635257 Interferon gamma Genentech IFN-G NSC-600662
Arm I Regional Hyperthermia plus Regional Single-Agent Chemotherapy Hyperthermic intravenous limb perfusion HILP plus Melphalan L-PAM NSC-8806
Arm II Regional Hyperthermia plus Regional Single-Agent Chemotherapy and Biological Response Modifier Therapy HILP as in Arm I plus L-PAM and Tumor Necrosis Factor Knoll TNF NSC-635257 Interferon gamma Genentech IFN-G NSC-600662
Detailed Description:
Patients with locally advanced melanoma confined to an extremity Stage IIIA or Stage IIIAB will be treated in a randomized Phase III study with hyperthermic isolated limb perfusion One arm of the study will be a standard 60 minute perfusion with melphalan as a single agent The second arm of the study will combine melphalan tumor necrosis factor and interferon-gamma in the isolated limb perfusion reproducing a regimen shown to have 100 response rates in a Phase II European trial Patients will be followed for local response rates duration of response treatment toxicity and disease-free survival
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 |
|---|---|---|---|
| 92-C-0105 | None | None | None |