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

NCT00673361 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-01-13

Study results available
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Summary

This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide plus sorafenib have on melanoma.

Conditions

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 & Collaborators

Principal Investigators

  • Michael A Morse, M.D. · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-01-31
Completion
2009-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00673361 on ClinicalTrials.gov