Know Cancer

or
forgot password


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 Stage IV 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

- 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-301

NCT ID:

NCT00083239

Start Date:

Completion Date:

Related Keywords:

  • Melanoma
  • Skin Cancer
  • Skin Neoplasms
  • Melanoma

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Mary Crowley Medical Research CenterDallas, Texas  75246
University of PittsburghPittsburgh, Pennsylvania  15261
University of ChicagoChicago, Illinois  60637
Emory University/Winship Cancer InstituteAtlanta, Georgia  30322-1013