Ex Vivo-Activated Lymph Node Lymphocytes in Treating Patients With Stage IIIC-IV Melanoma

This is an interventional treatment trial for Stage IIIC Skin Melanoma Read More

Inclusion Criteria:

• STEP 1

  • Participants must have a histologic diagnosis of melanoma either from a primary or metastatic site; Participants with brain metastases must have completed radiation therapy >30 days prior to enrollment
  • Participants must have American Joint Committee on Cancer (AJCC) stage IIIC unresected or IV disease

  • Patients with non-measureable or measurable disease are eligible. Measurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter for non-nodal lesions and short axis for nodal lesions to be recorded) as ≥ 20 mm by chest x-ray, as ≥ 10 mm with CT scan, or ≥ 10 mm with calipers by clinical exam. Malignant lymph nodes, to be considered pathologically enlarged and measurable, must be ≥ 15 mm in short axis when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm). At baseline and in follow-up, only the short axis will be measured and followed.

    • Tumor lesions that are situated in a previously irradiated area can be considered measurable as long as ≥ 30 days has passed since radiation to that area
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Life expectancy (untreated) of > 4 months, in the opinion of and as documented by the investigator
  • White blood count > 3,000/mcL
  • Absolute neutrophil count > 1,200/mcL
  • Platelet count > 100,000/mcL
  • Serum creatinine < 2.0 mg/dL
  • International normalized ratio (INR) ≤ 2.0
  • In the opinion of the investigator, participant must be medically fit to undergo surgical procedure
  • Participants treated with prior chemotherapy, cytotoxic chemotherapy, radiation, biotherapy, or any investigational agent > 30 days prior to lymph node removal are eligible
  • Women of child-bearing potential must agree to use adequate contraception (double barrier method of birth control or abstinence) during participation in the study; should a woman become pregnant or suspect that she is pregnant while she or her partner is participating in this study, she should inform the treating physician immediately
  • Participants must be disease free of prior invasive malignancies for > 5 years, with the exception of curatively treated basal cell or squamous cell carcinoma of the skin or cancer in-situ of the cervix
  • Participants must be able to understand and willing to sign a written informed consent document

• STEP 2

  • Successful removal of melanoma-draining lymph node (MDLN)
  • ECOG Performance status ≤ 1
  • White blood count > 3,000/mcL
  • Absolute neutrophil count > 1,500/mcL
  • Platelet count > 100,000/mcL
  • Serum creatinine < 2.0 mg/dL
  • Serum direct bilirubin < 2 x institutional upper limit of normal
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])
  • Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) < 2.5 X institutional upper limit of normal
  • Participants with liver metastases who do not meet the eligibility parameters may only be enrolled at the discretion of the principal investigator (PI)

Exclusion Criteria:

Step 1

• Participants who are taking immunosuppressive medications that cannot be discontinued (corticosteroids); participants who have discontinued immunosuppressive medications but be at least 1 week post their last dose. Patients who are taking physiologic replacement doses of corticosteroids equivalent to oral prednisone 10 mg per day will not be excluded.
• Participants who are receiving any other investigational agents
• Participants with a history of autoimmune disease requiring continuous treatment
• Participants receiving any medications or substances to treat active infection
• Pregnant or breastfeeding
• Participants with human immunodeficiency virus (HIV) or hepatitis, or known active cytomegalovirus (CMV), Epstein-Barr virus (EBV) or any other viral illness requiring treatment are ineligible because of the potential for pharmacokinetic interactions with ACT lymph node lymphocytes
• Any condition or behavior that in the judgment of the investigator, would compromise the participant's ability to participate in the study and/or comply with study procedures
• Patients with bleeding disorders are ineligible due to lymph node removal possibly causing excessive bleeding. Bleeding disorder will be defined by an INR level of > 2.0

Step 2 None