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

Stopped early · Phase 1

Conditions studied: Stage IIIC Skin Melanoma, Stage IV Melanoma

In brief

This phase I trial studies the safety and best dose of ex-vivo activated lymph node lymphocytes (X-ACT) as well as how well the immune system responds to X-ACT treatment in participants with stage IIIC-IV melanoma. X-ACT treatment involves removing a participant's lymph node(s) close to a melanoma tumor. These lymph nodes contain special kind of cells (called T cells) which can be activated (getting the cells to start up certain responses in the immune system) outside of the body in an approved laboratory. The activated T cells are then injected back into the same participant using an i.v. to help the participant's immune system to target melanoma. The participant will undergo regular blood testing to determine whether the X-ACT treatment has resulted in changes to the immune system and also whether the T cells which were given back to the patient persist in the blood stream over time. In addition, the effect of the X-ACT treatment on the growth or shrinkage of the participant's melanoma will be measured.

Key facts

Study ID: NCT02327390
Run by: Case Comprehensive Cancer Center
People needed: 3
Starts: 2015-03-17
Expected to finish: 2016-07-18
Last updated by the study team: 2018-12-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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