"Pilot Trial of Chemo-Switch Regimen to Treat Advanced Melanoma"

PHASE2TerminatedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

March 31, 2007

Primary Completion Date

January 31, 2009

Study Completion Date

January 31, 2009

Conditions
Melanoma
Interventions
DRUG

Concurrent decrescendo biochemotherapy regimen

"* Temozolomide: 200mg/m\^2, daily, PO, days 1-4~* Vinblastine: 1.5mg/m\^2, daily, IV, days 1-4~* Cisplatin: 20mg/m\^2, daily IV, days 1-4~* IL (interleukin)-2: - 18 milli-International unit (MIU)/m\^2, IVCI (intravenous continual infusion), day 1~* 9 MIU/m\^2, IVCI, day 2~* 4.5 MIU/m\^2, IVCI, days 3 \& 4~* Interferon (IFN) alpha: 5 MIU/m\^2, daily, SC (subcutaneously), days 1-5~* 5-day inpatient regimen, to be repeated every 21 days"

DRUG

Low-dose Temozolomide plus Sorafenib

Temozolomide: 75mg/m\^2, PO, QD (quaque die), 6 weeks on/2 weeks off Sorafenib: 400mg, PO, BID, 8 weeks

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Bayer

INDUSTRY

lead

Duke University

OTHER