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Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma, Skin Cancer

Thank you

Trial Information


Inclusion Criteria:



- Histologically or cytologically confirmed melanoma that is metastatic (unresectable
Stage IV per AJCC 2002)

- Patients with measurable disease defined as at least one measurable index lesion with
clearly defined margins

- ECOG Performance Status of 0, 1, or 2

- Expected survival ≥12 weeks

- Written informed consent

Exclusion Criteria:

- More than 1 prior chemotherapy or biotherapy regimen for metastatic melanoma

- Radiation therapy to >50% of the bone marrow. Patients must not have had prior
radiotherapy to index lesions unless they have clearly progressive disease in this
site or there is measurable disease outside the area of prior radiation.

- Clinically significant laboratory abnormalities

- Symptomatic CNS metastases

- Any malignancy within the 5 years immediately prior to the first dose of study
medication with the exception of basal cell or non-metastatic squamous cell carcinoma
of the skin, and carcinoma in-situ of the cervix

- The need for chronic (i.e., >7 days) oral or intravenous corticosteroid therapy

- Any comorbidity or condition which, in the opinion of the investigator, may interfere
with the assessments and procedures of this protocol

- Patients who are within 30 days of chemotherapy, radiation therapy, immunotherapy, or
other investigational medication for melanoma. Patients must have recovered from all
of the side effects of treatment in order to be enrolled.

- Pregnant or lactating women.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

PTH-303

NCT ID:

NCT00083252

Start Date:

Completion Date:

Related Keywords:

  • Melanoma
  • Skin Cancer
  • Skin Neoplasms
  • Melanoma

Name

Location

Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Mary Crowley Medical Research CenterDallas, Texas  75246
Tyler Cancer CenterTyler, Texas  75702
University of Colorado Health Sciences CenterDenver, Colorado  80262
Cancer Center of the CarolinasGreenville, South Carolina  29615
NYU School of MedicineNew York, New York  10016
University of Arkansas Medical SciencesLittle Rock, Arkansas  72205
Cancer Center of FloridaOcoee, Florida  34761
Indiana Hematology Oncology ConsultantsIndianapolis, Indiana  46202
Cancer Institute Medical Group, Inc.Santa Monica, California  90404
New Mexico Cancer Center AllianceAlbuquerque, New Mexico  87106
Fifth Avenue Medical HealthcareNew York, New York  10128
Cancer Care Northwest ResearchSpokane, Washington  99218