NCT00256282

Docetaxel and Vinorelbine Plus Sargramostim in Metastatic Malignant Melanoma

A Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in Patients With Metastatic Malignant Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: John P. Fruehauf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 U.S. there is an estimated 40,000 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. O'Day 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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Vinorelbine	30 mg/m2 IV over 6-10 min every 14 days
DRUG	Docetaxel	40mg/m2 IV over 1 hour every 14 days
DRUG	Sargramostim	250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days

Timeline

• Start date: 2003-04-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2005-11-21
• Last updated: 2018-05-03
• Results posted: 2018-05-03

Locations

1 site across 1 country: United States