Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256282
Status:
COMPLETED
Last Update Posted:
2018-05-03
First Post:
2005-11-17
Brief Title:
Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma
Sponsor:
John P Fruehauf
Organization:
University of California Irvine
Study Overview
Official Title:
A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma
Status:
COMPLETED
Status Verified Date:
2018-02
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:
This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful Without effective treatment metastatic melanoma is usually a severe and fatal disease Chemotherapy agents or combinations of chemotherapy agents have produced tumor shrinkage in some patients which has occasionally persisted This research involves treatment with a combination of chemotherapy drugs known to be active against melanoma alone The investigational purpose of this study is to determine if the combination of docetaxel vinorelbine and sargramostim will produce a response complete or partial in metastasis melanoma The researchers also wants to find out what side effects are associated with this combination of drugs
Detailed Description:
Annually in the US there is an estimated 40000 new cases of malignant melanoma and 7000 deaths This disease is becoming more common with its incidence increasing at a more rapid rate in the past decade than that of any other cancer except lung cancer in women Metastatic disease responds poorly to the usual treatments with only 2 out of 30 drugs tested DTIC and nitrosoureas showing response rates greater than 10 Complete responses are rare
Metastatic melanoma is a disease with few therapeutic options Multi-agent chemotherapy with cisplatin CDDP Dacarbazine DTIC Carmustine BCNU with or without Tamoxifen offers a 20 response rate but has failed to consistently demonstrate a significant improvement in overall survival OS or disease-free survival DFS when compared to a single agent DTIC
Recently investigators in an effort to combine the activity of biologic response modifiers with chemotherapy have developed combination biochemotherapy for metastatic melanoma Legha et al reported an overall objective response rate of 64 with a 5-day biochemotherapy regimen ODay et al reported similar results overall response rate of 57 using a modified 5-day biochemotherapy regimen
The above regimens all have significant toxicities and modest response rates Clearly more effective less toxic regimens are needed
Vinorelbine tartrate Navelbine and Docetaxel Taxotere have both shown activity against melanoma Additionally the combination of both drugs has shown enhanced activity against melanoma
Metastatic melanoma is a disease with few therapeutic options Multi-agent chemotherapy with cisplatin CDDP Dacarbazine DTIC Carmustine BCNU with or without Tamoxifen offers a 20 response rate but has failed to consistently demonstrate a significant improvement in overall survival OS or disease-free survival DFS when compared to a single agent DTIC
Recently investigators in an effort to combine the activity of biologic response modifiers with chemotherapy have developed combination biochemotherapy for metastatic melanoma Legha et al reported an overall objective response rate of 64 with a 5-day biochemotherapy regimen ODay et al reported similar results overall response rate of 57 using a modified 5-day biochemotherapy regimen
The above regimens all have significant toxicities and modest response rates Clearly more effective less toxic regimens are needed
Vinorelbine tartrate Navelbine and Docetaxel Taxotere have both shown activity against melanoma Additionally the combination of both drugs has shown enhanced activity against melanoma
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-2010-00217 | OTHER | NCI Clinical Trials Reporting Program CTRP | None |
| 2002-2763 | OTHER | None | None |