Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002974
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
1999-11-01
Brief Title:
Whole-Body Hyperthermia Plus Chemotherapy in Treating Patients With Advanced Sarcoma
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
Official Title:
A Phase II Study of Whole Blood Hyperthermia and Ice Chemotherapy in Sarcoma Patients
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 Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with whole-body hyperthermia may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of whole-body hyperthermia plus combination chemotherapy in treating patients who have advanced sarcoma that is metastatic or that cannot be surgically removed
PURPOSE Phase II trial to study the effectiveness of whole-body hyperthermia plus combination chemotherapy in treating patients who have advanced sarcoma that is metastatic or that cannot be surgically removed
Detailed Description:
OBJECTIVES I Evaluate the combination of 418 degrees Celsius whole body hyperthermia WBH and ifosfamidecarboplatinetoposide ICE chemotherapy in patients with advanced sarcoma II Assess the efficacy of this combination of therapy III Assess the clinical toxicity of WBH and ICE in these patients IV Obtain pilot data on the effect of WBH and ICE on cytokine induction in these patients
OUTLINE Treatment of whole body hyperthermia WBH and ifosfamidecarboplatinetoposide ICE is given every 3-4 weeks On day 1 of the treatment ifosfamide is administered intravenously over 60 minutes at the beginning of hyperthermia Carboplatin is administered intravenously over 20 minutes while at the maximum temperature Etoposide is administered intravenously over 60 minutes while receiving hyperthermia and on day 2 and 3 after hyperthermia Patient disease status is reevaluated after 2 courses If there is no disease progression treatment continues for a maximum of 4 courses
PROJECTED ACCRUAL Approximately 17-34 patients will be accrued for this study
OUTLINE Treatment of whole body hyperthermia WBH and ifosfamidecarboplatinetoposide ICE is given every 3-4 weeks On day 1 of the treatment ifosfamide is administered intravenously over 60 minutes at the beginning of hyperthermia Carboplatin is administered intravenously over 20 minutes while at the maximum temperature Etoposide is administered intravenously over 60 minutes while receiving hyperthermia and on day 2 and 3 after hyperthermia Patient disease status is reevaluated after 2 courses If there is no disease progression treatment continues for a maximum of 4 courses
PROJECTED ACCRUAL Approximately 17-34 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-G97-1217 | None | None | None |
| WCCC-CO-9672 | None | None | None |