Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00418496
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2007-01-02
Brief Title:
Interleukin-2 With Sorafenib BAY 43-9006 for Unresectable or Metastatic Clear Cell Renal Carcinoma RCC and Metastatic Melanoma
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
A Phase I Study of Bolus High Dose Interleukin-2 With Sorafenib BAY 43-9006 in Patients With Unresectable or Metastatic Clear Cell Renal Carcinoma RCC and Metastatic Melanoma
Status:
COMPLETED
Status Verified Date:
2017-02
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:
The primary objective of this study will be to determine the toxicity and Maximum Tolerated Dose MTD of the combination of high dose aldesleukin and sorafenib in previously untreated patients with metastatic or unresectable clear cell renal carcinoma RCC and metastatic melanoma
Detailed Description:
Rationale Previous research indicates that high dose aldesleukin produces tumor regression through upregulation of the patients immune system Research suggests that sorafenib directly targets tumors by inhibiting angiogenic activity with possibly some cytotoxicity Angiogenic refers to the formation of new blood vessels that support tumor growth Cytotoxicity is the measurement of a chemicals ability to damage or kill cancer cells Researchers have hypothesized that the complementary ways aldesleukin and sorafenib work and their non-overlapping toxicity profiles may create a reasonable combination for the treatment of metastatic renal cell carcinoma and metastatic melanoma The current Phase I study will evaluate toxicity in patients through assessing various dose levels of sorafenib in combination with aldesleukin
Purpose The primary objective is to determine the maximum tolerated dose and characterize the toxicity of high dose aldesleukin and sorafenib in patients with unresectable or metastatic clear cell renal carcinoma and metastatic melanoma Secondary objectives include determining progression free survival in patients evaluating in a preliminary manner response rates and assessing other measurements in study participants
Treatment Study participants will be given bolus high dose aldesleukin and sorafenib Aldesleukin will be provided through intravenous infusions on days 1 through 5 Each 5 day treatment is considered a cycle The second cycle of aldesleukin will start on day 15 Two cycles are considered 1 course All study participants will be given the same dose level of aldesleukin No dose reductions will be permitted Sorafenib will then be administered on day 29 Since this study will assess the maximum tolerated dose of sorafenib some study participants will receive different amounts of this drug compared to others depending upon when each individual enrolls in the study Each group of 3 to 6 study participants will receive a higher dose of sorafenib until the maximum tolerated dose is established Imagining studies will be performed to determine response to treatment during week 12 If the patient has stable or responding disease a second course will be administered on the same schedule Patients without disease response will be given one additional course of aldesleukin past maximal response When it is decided that no further aldesleukin will be provided to patients sorafenib at the Food and Drug Administration approved dose may be continued until there is a lack of clinical benefit or intolerable side effects develop Several tests and exams will be given throughout the study to closely monitor patients
Purpose The primary objective is to determine the maximum tolerated dose and characterize the toxicity of high dose aldesleukin and sorafenib in patients with unresectable or metastatic clear cell renal carcinoma and metastatic melanoma Secondary objectives include determining progression free survival in patients evaluating in a preliminary manner response rates and assessing other measurements in study participants
Treatment Study participants will be given bolus high dose aldesleukin and sorafenib Aldesleukin will be provided through intravenous infusions on days 1 through 5 Each 5 day treatment is considered a cycle The second cycle of aldesleukin will start on day 15 Two cycles are considered 1 course All study participants will be given the same dose level of aldesleukin No dose reductions will be permitted Sorafenib will then be administered on day 29 Since this study will assess the maximum tolerated dose of sorafenib some study participants will receive different amounts of this drug compared to others depending upon when each individual enrolls in the study Each group of 3 to 6 study participants will receive a higher dose of sorafenib until the maximum tolerated dose is established Imagining studies will be performed to determine response to treatment during week 12 If the patient has stable or responding disease a second course will be administered on the same schedule Patients without disease response will be given one additional course of aldesleukin past maximal response When it is decided that no further aldesleukin will be provided to patients sorafenib at the Food and Drug Administration approved dose may be continued until there is a lack of clinical benefit or intolerable side effects develop Several tests and exams will be given throughout the study to closely monitor patients
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-2011-03199 | REGISTRY | Clinical Trial Reporting Program CTRP | None |