Evaluate Safety/Tolerability Intra-Arterial Temozolomide in Patients w/Extremity Melanoma by Isol… (NCT01127594) | Clinical Trial Compass
CompletedPhase 1
Evaluate Safety/Tolerability Intra-Arterial Temozolomide in Patients w/Extremity Melanoma by Isolated Limb Infusion
United States29 participantsStarted 2010-07
Plain-language summary
The purpose of this study is to determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities associated with this treatment. This study also aims to determine the maximum tolerated dose of intra-arterial administration of temozolomide during ILI that will be used in a phase II trial.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patient must have undergone a previous Melphalan based regional therapy for which they did not respond optimally and present with persistent, progressive, or recurrent disease.
✓. Patient must be 18 years of age or older.
✓. Patient must have an ECOG status of 0-1.
✓. Patient must have histologically proven primary or recurrent extremity melanoma, stage IIIB, IIIC, or IV
✓. Patients with Stage IIIC disease must either have had regional lymph nodes previously removed or will have them removed at the time of regional treatment.
✓. Patients with Stage IV disease must have had all distant disease resected at least 30 days prior to regional treatment.
✓. Disease to be treated by ILI must be distal to the planned site of tourniquet placement
✓. Patient's disease must be bi-dimensionally measurable by caliper or radiological method as defined in the RECIST criteria.
Exclusion criteria
✕. Cardiac disease: Congestive heart failure \> class II NYHA.
✕. Known brain metastasis.
✕. Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management.
✕. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
What they're measuring
1
Safety Profile of intra-arterial temozolomide and maximum tolerated dose of temozolomide