EPO906 Therapy in Patients With Advanced Melanoma

Novartis

Status and phase

Completed

Phase 2

Conditions

Melanoma

Treatments

Drug: epothilone b

Study type

Interventional

Funder types

Industry

Identifiers

NCT00035165

CEPO906A2206

Details and patient eligibility

About

This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.

Enrollment

51 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

The following patients may be eligible for this study:

Patients with advanced metastatic melanoma defined as poor prognosis Stage III melanoma and Stage IV disease, which has been histologically or cytologically confirmed with at least one measurable lesion not including bone metastases (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
Patients with poor prognosis Stage III melanoma must have locally advanced unresectable disease that is measurable (repeat histological or cytological confirmation is not necessary at the time of study entry if previous results are available and there is no question in the investigator's opinion as to the diagnosis)
Must have a life expectancy of greater than three (3) months
Prior immunotherapy with interferon alpha in the adjuvant setting is permitted, but must have been completed > 4 weeks prior to treatment
Prior vaccine therapy is permitted, but must have been completed > 4 weeks prior to treatment
Patient has no major impairment of hematological function (red blood cell transfusions and repeat evaluations for study entry are allowed).

Exclusion Criteria

The following patients are not eligible for this study:

Patients with choroidal ocular melanoma
Patients with symptomatic CNS metastases or leptomeningeal involvement
Patients with renal or hepatic dysfunction
Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
Patients with severe cardiac insufficiency
Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
Patients who have received any investigational compound or anti-melanoma vaccine within the past 28 days or those who are planning to receive other investigational drugs while participating in the study
Patients who had received radiotherapy within the last 4 weeks to a site which will be the reference for disease assessment (however, new or progressive lesions in the previously irradiated fields of these patients may be used for disease assessment and patients must have recovered from the side effects of radiotherapy)
Patients receiving chemotherapy within the last four weeks
History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
HIV+ patients
Pregnant or lactating females.