T Cell Transfer With or Without Dendritic Cell Vaccination in Patients With Melanoma

• Status: Recruiting
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to learn if dendritic cell vaccine will increase the effect of tumor infiltrating lymphocytes given with chemotherapy and interleukin-2 in patients with melanoma.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska University Hospital
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Interleukin-2; Vaccines; Vidarabine

Criteria

Inclusion Criteria:

• Patients with measurable (direct on body surface or by x-ray and/or CT) malignant melanoma (including uveal melanoma), that is advanced, inoperable stage III (advanced regional lymph node metastases, or more than 5 in-transit metastases, N2) or stage IV (distant metastasis, M1) according to the AJCC classification and confirmed by histology/cytology and appropriate radiological investigations.

• Patients with a palpable resectable lesion located in the skin or in a lymph node or a lesion accessible by (core) biopsy.

• Disease should be in progression and the patient should have exhausted other approved therapeutic options, if not the physician considers that an earlier study entry benefits the patient.

• Ambulatory performance status (ECOG 0, 1, 2).

• Age 18-74 and life expectancy greater than 3 months.

Exclusion Criteria:

• Any of the above criteria are not met.

• Significant history or current evidence of cardiovascular disease (e.g. uncontrolled congestive heart failure or hypertension, unstable coronary artery disease or serious arrhythmias) or major respiratory diseases. In questionable cases, a stress test should be performed.

• Recipients of a major organ allograft. Autoimmune diseases such as, but not limited to, inflammatory bowel disease or multiple sclerosis. Vitiligo is not an exclusion criterion. Other serious chronic diseases.

• Other serious illnesses, e.g. active infections requiring antibiotics, bleeding disorders.

• Has had prior systemic cancer therapy within the past four weeks at the time of the start of the lymphodepletion regimen.

• Patients diagnosed with prior malignancies (except adequately treated basal cell carcinomas of the skin or in situ carcinomas of the skin or in situ carcinomas of the cervix, surgically cured) within the past 5 years.

• Patients with second advanced malignancies concurrently.

• Active CNS metastases. (Note: Patients with brain metastases that have been completely resected at least one month prior to registration or have undergone gamma knife treatment with no evidence of recurrence on CT and who are neurologically stable, are not excluded).

• Organic brain syndrome or significant psychiatric disorder which would preclude participation in the full protocol and follow-up.

• Immunodeficiency, previous splenectomy or radiation therapy of the spleen.

• Screening laboratory values:

a) Inadequate hematologic function defined by: i) White blood count (WBC) <3.0 x 109/l ii) Platelet count <100x109/l iii) Hemoglobin level <100 g/l b) Inadequate hepatic function as defined by either: i) Total bilirubin level >1.5 times the upper limit of normal (ULN) ii) Aspartate amino transferase (AST) or alanine amino transferase (ALT) >3 times the ULN (if related to liver metastases >5 times the ULN) c) Inadequate renal function defined as serum creatinine >1.5 times the ULN

• Infectious diseases that can be transmitted via contact with blood, such as HIV, Hepatitis B and C.

• Women who are pregnant or nursing will be excluded because of the potentially dangerous effects of the preparative chemotherapy on the fetus.