Adoptive Cell Therapy Following Non-myeloablate Chemotherapy in Metastatic Melanoma Patients

NCT ID: NCT00287131

Last Updated: 2012-03-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2013-11-30

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.

Conditions

Metastatic Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Procedure - Adoptive cell transfer

Procedure - Adoptive cell transfer

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Metastatic Melanoma patients failing to prior chemo and immunotherapy with good performance status.

Exclusion Criteria

• Brain mets

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jacob Schachter, MD

Role: PRINCIPAL_INVESTIGATOR

Head, Ella Institute, Sheba Medical Center

Locations

Sheba Medical Center

Tel Litwinsky, Tel Hashomer, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Jacob Schachter, MD

Role: CONTACT

Jacob.Schachter@sheba.health.gov.il

972-3-5304907

Aviad Yair

Role: CONTACT

Aviad.Yair@sheba.health.gov.il

972-543355595

Facility Contacts

Jacob Schachter, MD

Role: primary

Jacob.Schachter@sheba.health.gov.il

972-3-5304907

Aviad Yair

Role: backup

Aviad.Yair@sheba.health.gov.il

972-543355595

References

Besser MJ, Shapira-Frommer R, Treves AJ, Zippel D, Itzhaki O, Hershkovitz L, Levy D, Kubi A, Hovav E, Chermoshniuk N, Shalmon B, Hardan I, Catane R, Markel G, Apter S, Ben-Nun A, Kuchuk I, Shimoni A, Nagler A, Schachter J. Clinical responses in a phase II study using adoptive transfer of short-term cultured tumor infiltration lymphocytes in metastatic melanoma patients. Clin Cancer Res. 2010 May 1;16(9):2646-55. doi: 10.1158/1078-0432.CCR-10-0041. Epub 2010 Apr 20.

Reference Type: RESULT

PMID: 20406835 (View on PubMed)

Nissani A, Lev-Ari S, Meirson T, Jacoby E, Asher N, Ben-Betzalel G, Itzhaki O, Shapira-Frommer R, Schachter J, Markel G, Besser MJ. Comparison of non-myeloablative lymphodepleting preconditioning regimens in patients undergoing adoptive T cell therapy. J Immunother Cancer. 2021 May;9(5):e001743. doi: 10.1136/jitc-2020-001743.

Reference Type: DERIVED

PMID: 33990415 (View on PubMed)

Itzhaki O, Jacoby E, Nissani A, Levi M, Nagler A, Kubi A, Brezinger K, Brayer H, Zeltzer LA, Rozenbaum M, Vernitsky H, Markel G, Toren A, Avigdor A, Schachter J, Besser MJ. Head-to-head comparison of in-house produced CD19 CAR-T cell in ALL and NHL patients. J Immunother Cancer. 2020 Mar;8(1):e000148. doi: 10.1136/jitc-2019-000148.

Reference Type: DERIVED

PMID: 32152221 (View on PubMed)

Nemlich Y, Greenberg E, Ortenberg R, Besser MJ, Barshack I, Jacob-Hirsch J, Jacoby E, Eyal E, Rivkin L, Prieto VG, Chakravarti N, Duncan LM, Kallenberg DM, Galun E, Bennett DC, Amariglio N, Bar-Eli M, Schachter J, Rechavi G, Markel G. MicroRNA-mediated loss of ADAR1 in metastatic melanoma promotes tumor growth. J Clin Invest. 2013 Jun;123(6):2703-18. doi: 10.1172/JCI62980.

Reference Type: DERIVED

PMID: 23728176 (View on PubMed)

Other Identifiers

SHEBA-04-3518-JS-CTIL

Identifier Type: -

Identifier Source: org_study_id