Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256230
Status:
COMPLETED
Last Update Posted:
2016-12-08
First Post:
2005-11-17
Brief Title:
Disulfiram in Patients With Metastatic Melanoma
Sponsor:
John P Fruehauf
Organization:
University of California Irvine
Study Overview
Official Title:
Evaluation of Disulfiram in Patients With Metastatic Melanoma and at Least One Prior Systemic Therapy Phase III
Status:
COMPLETED
Status Verified Date:
2011-12
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:
Melanoma remains a malignancy that is largely resistant to chemotherapy Metastatic disease responds poorly to the treatments used today with only 2 out of 30 drugs tested DTIC and nitrosoureas showing response rates greater than 10 and complete responses are rare DTIC-based regimen has been recognized as a standard chemotherapy for advanced melanoma and temozolomide demonstrated efficacy equal to that of DTIC and is an oral alternative agent that also crosses the blood brain barrier Randomized phase III trials have shown no survival benefit of adding other agents cisplatin BCNU and tamoxifen Biochemotherapy is being developed extensively with moderate improvement in the responsive rate approximately 50 and is under evaluation in randomized trial to identify whether there is survival benefit to this strategy compared with chemotherapy alone Recently a randomized phase III study comparing chemotherapy cisplatin dacarbazine and tamoxifen with biochemotherapy the same chemotherapy regimen plus high-dose IL-2 and interferon alfa have shown 44 response rate for biochemotherapy vs 27 for chemotherapy However the tendency toward an increased response rate in patients who received biochemotherapy did not translate into an increase in overall survival and there was in fact a trend for a survival advantage in patients receiving chemotherapy alone median survival 107 vs 158 months New agents or combinations need to be developed for this refractory malignancy
The purpose of this study is to determine the response rate and evaluate the toxicity of disulfiram DSF in the treatment of Stage IV melanoma
The advantages of using DSF in this phase III trial are the following
DSF has been used as a drug for many years for the treatment of alcoholism Its mechanism pharmacokinetics toxicitytolerable dose are well known and this drug is relatively non-toxic by itself at therapeutic dose Doses of greater than 3000mgm2 can cause reversible confusion
DSF can be taken orally therefore it is convenient to administer
DSF can penetrate the blood-brain barrier unlike dacarbazine and many other chemotherapy agents therefore it might have an active effect on CNS metastasis
This study is designed to include women and minorities but is not designed to measure differences of intervention effect
The purpose of this study is to determine the response rate and evaluate the toxicity of disulfiram DSF in the treatment of Stage IV melanoma
The advantages of using DSF in this phase III trial are the following
DSF has been used as a drug for many years for the treatment of alcoholism Its mechanism pharmacokinetics toxicitytolerable dose are well known and this drug is relatively non-toxic by itself at therapeutic dose Doses of greater than 3000mgm2 can cause reversible confusion
DSF can be taken orally therefore it is convenient to administer
DSF can penetrate the blood-brain barrier unlike dacarbazine and many other chemotherapy agents therefore it might have an active effect on CNS metastasis
This study is designed to include women and minorities but is not designed to measure differences of intervention effect
Detailed Description:
None
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 |
|---|---|---|---|
| 2001-2038 | OTHER | University of California Irvine | None |