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

Primary Purpose

Metastatic Melanoma

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Procedure - Adoptive cell transfer

About this trial

This is an interventional treatment trial for Metastatic Melanoma focused on measuring melanoma, metastatic melanoma, adoptive immunotherapy, IL-2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Metastatic Melanoma patients failing to prior chemo and immunotherapy with good performance status. Exclusion Criteria: Brain mets

Sites / Locations

Sheba Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Response rate and toxicity

Secondary Outcome Measures

Full Information

NCT ID

NCT00287131

First Posted

February 2, 2006

Last Updated

March 28, 2012

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00287131

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2006 (undefined)

Primary Completion Date

December 2012 (Anticipated)

Study Completion Date

November 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sheba Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Melanoma

Keywords

melanoma, metastatic melanoma, adoptive immunotherapy, IL-2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Procedure - Adoptive cell transfer

Intervention Description

Procedure - Adoptive cell transfer

Primary Outcome Measure Information:

Title

Response rate and toxicity

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Metastatic Melanoma patients failing to prior chemo and immunotherapy with good performance status. Exclusion Criteria: Brain mets

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jacob Schachter, MD

Phone

972-3-5304907

Jacob.Schachter@sheba.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

Aviad Yair

Phone

972-543355595

Aviad.Yair@sheba.health.gov.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jacob Schachter, MD

Organizational Affiliation

Head, Ella Institute, Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sheba Medical Center

City

Tel hashomer

ZIP/Postal Code

52621

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacob Schachter, MD

Phone

972-3-5304907

Jacob.Schachter@sheba.health.gov.il

First Name & Middle Initial & Last Name & Degree

Aviad Yair

Phone

972-543355595

Aviad.Yair@sheba.health.gov.il

First Name & Middle Initial & Last Name & Degree

Jacob Schachter, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

20406835

Citation

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.

Results Reference

result

PubMed Identifier

33990415

Citation

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.

Results Reference

derived

PubMed Identifier

32152221

Citation

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.

Results Reference

derived

PubMed Identifier

23728176

Citation

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.

Results Reference

derived

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

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