Metastatic Melanoma
Conditions
Keywords
melanoma, metastatic melanoma, adoptive immunotherapy, IL-2
Brief summary
Metastatic melanoma is an aggressive and highly malignant cancer. The five-year survival rate of patients with metastatic disease is less than 5% with a median survival of only 6-10 months. Drugs like Dacarbazin (DTIC) as a single agent or in combination with other chemotherapy agents, have a response rate of 15-30%, but the duration of response is usually short, with no impact on survival. Interleukin-2 (IL-2) based immunotherapy has shown more promising results. This form of therapy has a similar response rate with some patients achieving a durable complete response. Recently the National Institute of Health (NIH) reported that by using lympho-depleting chemotherapy, followed by an adoptive transfer of large numbers of anti-tumor specific tumor-infiltrating lymphocytes (TIL), an objective regression was achieved in 51% of patients with metastatic melanoma. Objectives: To introduce the TIL technology to advanced metastatic melanoma patients in Israel.
Interventions
PROCEDUREProcedure - Adoptive cell transfer
Procedure - Adoptive cell transfer
Sponsors
Sheba Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Metastatic Melanoma patients failing to prior chemo and immunotherapy with good performance status.
Exclusion criteria
* Brain mets
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate and toxicity | 6 months |
Countries
Israel
Contacts
Primary ContactJacob Schachter, MD
Backup ContactAviad Yair
Outcome results
None listed