Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004141
Status:
COMPLETED
Last Update Posted:
2013-09-05
First Post:
1999-12-10
Brief Title:
Combination Chemotherapy Plus Biological Therapy in Treating Patients With Metastatic Melanoma
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Phase II Study of Outpatient CDDP and DTIC Followed by GM-CSF IFN-a2b and IL-2 in Patients With Advanced Melanoma
Status:
COMPLETED
Status Verified Date:
2013-09
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 Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing Combining more than one drug with different types of biological therapies may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus biological therapy in treating patients who have metastatic melanoma
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus biological therapy in treating patients who have metastatic melanoma
Detailed Description:
OBJECTIVES
Determine the toxicity of cisplatin and dacarbazine followed by sargramostim GM-CSF interferon alfa and interleukin-2 in patients with metastatic melanoma
Determine the objective response rate relapse free survival and overall survival of these patients on this regimen
OUTLINE Patients receive cisplatin IV over 1 hour and dacarbazine IV over 30-60 minutes sequentially on day 1 followed by sargramostim GM-CSF subcutaneously SC on days 2-7 interleukin-2 SC on days 8-14 and interferon alfa SC on days 8 10 12 and 14 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression and then every 8-12 weeks thereafter
PROJECTED ACCRUAL A total of 15-45 patients will be accrued for this study within 3 years
Determine the toxicity of cisplatin and dacarbazine followed by sargramostim GM-CSF interferon alfa and interleukin-2 in patients with metastatic melanoma
Determine the objective response rate relapse free survival and overall survival of these patients on this regimen
OUTLINE Patients receive cisplatin IV over 1 hour and dacarbazine IV over 30-60 minutes sequentially on day 1 followed by sargramostim GM-CSF subcutaneously SC on days 2-7 interleukin-2 SC on days 8-14 and interferon alfa SC on days 8 10 12 and 14 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 8 weeks until disease progression and then every 8-12 weeks thereafter
PROJECTED ACCRUAL A total of 15-45 patients will be accrued for this study within 3 years
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-G99-1615 | None | None | None |
| UCCRC-9372 | None | None | None |
| UCCRC-CTRC-9821 | None | None | None |