Phase IIB TL + YCWP + DC in Melanoma

Launched by ELIOS THERAPEUTICS, LLC · Nov 23, 2014

Keywords

ClinConnect Summary

Stage III and Stage IV (resected) melanoma patients will be identified prior to definitive surgery and screened for inclusion/exclusion criteria. Eligible patients will be counseled and consented for tissue procurement. Enrolled patients will have their disease surgically resected and a portion 1mg minimum of their melanoma sterilely frozen in provided freezing vials and storage tubes. This tissue will be shipped in liquid nitrogen shippers through FedEx to our central facility in Greenville SC and stored frozen until vaccine preparation. If patients cannot be rendered disease-free, they wi...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18 years or older
• • Eastern Cooperative Oncology Group (ECOG) performance status 0,1 (Appendix D)
• • AJCC stage III or IV completely resectable melanoma identified before surgery
• • Approximately 1 mg (1 cm3) of accessible and dispensable tumor that will not interfere with pathologic staging
• • Clinically disease-free after surgery
• • Completing SoC adjuvant therapy per NCCN guidelines to include chemotherapy, radiation therapy, and/or biologic therapy as clinically indicated. (Consent #2 should be signed as close to completion of SoC as possible but may overlap completion by up to one month.)
• • Vaccinations initiated between 3 weeks and 3 months from completion of SoC multi-modality cancer care
• * Adequate organ function as determined by the following laboratory values:
• • ANC ≥ 1,000/μL
• • Platelets ≥ 75,000/μL
• • Hgb ≥ 9 g/dL
• • Creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥ 50%
• • Total bilirubin ≤ 1.5 ULN
• • ALT and AST ≤ 1.5 ULN
• • For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
• • Signed informed consent
• Exclusion Criteria:
• • Evidence of residual disease after surgery and SoC adjuvant therapies
• • Insufficient tumor available to produce vaccine
• • ECOG \>2 performance status (Appendix D)
• • Immune deficiency disease or known history of HIV, HBV, HCV
• • Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
• • Pregnancy (assessed by urine HCG)
• • Breast feeding
• • Active pulmonary disease requiring medication to include multiple inhalers (\>2 inhalers and one containing steroids)
• • Involved in other experimental protocols (except with permission of the other study PI)