Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002973
Status:
COMPLETED
Last Update Posted:
2015-10-02
First Post:
1999-11-01
Brief Title:
Melphalan and Whole-Body Hyperthermia in Treating Patients With Advanced Melanoma
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
Phase II Evaluation of IV Melphalan L-PAM and Whole Body Hyperthermia WBH for Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2015-09
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature Combining hyperthermia with chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of melphalan and whole-body hyperthermia in treating patients with advanced melanoma
PURPOSE Phase II trial to study the effectiveness of melphalan and whole-body hyperthermia in treating patients with advanced melanoma
Detailed Description:
OBJECTIVES I Evaluate the combination of 418 degrees Celsius whole body hyperthermia WBH and melphalan L-PAM in patients with advanced melanoma II Assess the efficacy of this combination of therapy III Assess the clinical toxicity of WBH and L-PAM in these patients IV Obtain pilot data on the effect of WBH and L-PAM on cytokine induction in these patients
OUTLINE The combination of whole body hyperthermia WBH and melphalan L-PAM is administered on week 1 The infusion of L-PAM is administered at a constant rate over approximately 10 minutes beginning 20 minutes after achieving target temperature of 418 degrees Celsius by esophageal or axillary temperature probe WBH is continued for an additional 40 minutes for a total of 60 minutes On week 5 or 6 patients receive another combination of WBH and L-PAM Disease status is reevaluated at least every 2 courses Patients without progressive disease continue therapy of WBH and L-PAM every 4 weeks for a maximum of 6 courses
PROJECTED ACCRUAL Approximately 34 patients will be accrued for this study
OUTLINE The combination of whole body hyperthermia WBH and melphalan L-PAM is administered on week 1 The infusion of L-PAM is administered at a constant rate over approximately 10 minutes beginning 20 minutes after achieving target temperature of 418 degrees Celsius by esophageal or axillary temperature probe WBH is continued for an additional 40 minutes for a total of 60 minutes On week 5 or 6 patients receive another combination of WBH and L-PAM Disease status is reevaluated at least every 2 courses Patients without progressive disease continue therapy of WBH and L-PAM every 4 weeks for a maximum of 6 courses
PROJECTED ACCRUAL Approximately 34 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-G97-1216 | None | None | None |
| WCCC-CO-9571 | None | None | None |