Back to resultsT-cell Based Immunotherapy for of Melanoma
Primary Purpose
Melanoma
Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
cyclophosphamide, fludarabine, T-cells, Interleukin-2
Sponsored by
About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
Inclusion Criteria:
- Patients with histological proven skin derived progressive metastatic or locally advanced malignant melanoma. Further inclusion criteria: Performance Status 0 to 1, surgical available metastasis, at least one measurable lesion, acceptable CBC and blood chemistry results. Acceptable organ functions.
Exclusion Criteria:
- Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
Sites / Locations
- Department of Oncology, Copenhagen University Hospital, Herlev
Outcomes
Primary Outcome Measures
toxicity
Secondary Outcome Measures
immune response
tumor response
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00937625
Brief Title
T-cell Based Immunotherapy for of Melanoma
Official Title
T-cell Based Immunotherapy for Treatment of Patients With Disseminated Melanoma.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Inge Marie Svane
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to investigate the toxicity and clinical response of therapy with tumor infiltrating lymphocytes as treatment for advanced melanoma.
Patient will receive a single treatment consisting of conditioning chemotherapy for seven days (cyclophosphamide for two days and fludarabine for five days), intravenous infusion of high number of in vitro expanded tumor infiltrating lymphocytes followed by two weeks with daily low-dose interleukine-2. Patients will be evaluated for toxicity, tumor response, and immune response.
After the first 6 patients the treatment with IL-2 has been changed to include higher doses of IL-2 (see intervention)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
cyclophosphamide, fludarabine, T-cells, Interleukin-2
Other Intervention Name(s)
Cyclophosphamide, Sendoxan®, Baxter A/S, Fludarabine, Fludara®, Bayer Shering, Interleukin-2, Proleukin®, Chiron B.V.
Intervention Description
Two days of cyclophosphamide (60 mg/kg i.v.) and five days of fludarabine (25 mg/m2 i.v.). Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells). Followed by daily sc injections of 2 MIE Interleukin-2 for two weeks. After the first 6 patients the dose of IL-2 has been changed to an i.v. decrescendo regimen using 18 MIU/m2 infused over 6, 12 and 24 hours and then 4.5 MIU/m2 infused over 24 hours for three days.
Primary Outcome Measure Information:
Title
toxicity
Time Frame
week 0 to 20
Secondary Outcome Measure Information:
Title
immune response
Time Frame
week 0 to 20
Title
tumor response
Time Frame
week 8 and every 3rd week until progression
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with histological proven skin derived progressive metastatic or locally advanced malignant melanoma. Further inclusion criteria: Performance Status 0 to 1, surgical available metastasis, at least one measurable lesion, acceptable CBC and blood chemistry results. Acceptable organ functions.
Exclusion Criteria:
Patients with a history of any other malignancies less than five years ago. Brain metastases. Other significant illness including severe allergy, asthma, DM, angina pectoris, congestive heart failure, chronic infections, or active autoimmune disease. Treatment with immune suppressive drugs, experimental drugs, or antineoplastic drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge Marie Svane, Professor, MD
Organizational Affiliation
Department of Oncology, Copenhagen University Hospital, Herlev, Herlev Ringvej 75, DK-2730 Herlev, Denmark
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rikke Andersen, MD
Organizational Affiliation
Center for Cancer Immune Therapy, department of Oncology, Herlev Hospital, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Oncology, Copenhagen University Hospital, Herlev
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
34813506
Citation
Kristensen NP, Heeke C, Tvingsholm SA, Borch A, Draghi A, Crowther MD, Carri I, Munk KK, Holm JS, Bjerregaard AM, Bentzen AK, Marquard AM, Szallasi Z, McGranahan N, Andersen R, Nielsen M, Jonsson GB, Donia M, Svane IM, Hadrup SR. Neoantigen-reactive CD8+ T cells affect clinical outcome of adoptive cell therapy with tumor-infiltrating lymphocytes in melanoma. J Clin Invest. 2022 Jan 18;132(2):e150535. doi: 10.1172/JCI150535.
Results Reference
derived
PubMed Identifier
32747469
Citation
Borch TH, Andersen R, Ellebaek E, Met O, Donia M, Svane IM. Future role for adoptive T-cell therapy in checkpoint inhibitor-resistant metastatic melanoma. J Immunother Cancer. 2020 Jul;8(2):e000668. doi: 10.1136/jitc-2020-000668.
Results Reference
derived
PubMed Identifier
27006492
Citation
Andersen R, Donia M, Ellebaek E, Borch TH, Kongsted P, Iversen TZ, Holmich LR, Hendel HW, Met O, Andersen MH, Thor Straten P, Svane IM. Long-Lasting Complete Responses in Patients with Metastatic Melanoma after Adoptive Cell Therapy with Tumor-Infiltrating Lymphocytes and an Attenuated IL2 Regimen. Clin Cancer Res. 2016 Aug 1;22(15):3734-45. doi: 10.1158/1078-0432.CCR-15-1879. Epub 2016 Mar 22.
Results Reference
derived
PubMed Identifier
23014345
Citation
Donia M, Hansen M, Sendrup SL, Iversen TZ, Ellebaek E, Andersen MH, Straten Pt, Svane IM. Methods to improve adoptive T-cell therapy for melanoma: IFN-gamma enhances anticancer responses of cell products for infusion. J Invest Dermatol. 2013 Feb;133(2):545-52. doi: 10.1038/jid.2012.336. Epub 2012 Sep 27.
Results Reference
derived
PubMed Identifier
22909342
Citation
Ellebaek E, Iversen TZ, Junker N, Donia M, Engell-Noerregaard L, Met O, Holmich LR, Andersen RS, Hadrup SR, Andersen MH, thor Straten P, Svane IM. Adoptive cell therapy with autologous tumor infiltrating lymphocytes and low-dose Interleukin-2 in metastatic melanoma patients. J Transl Med. 2012 Aug 21;10:169. doi: 10.1186/1479-5876-10-169.
Results Reference
derived
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T-cell Based Immunotherapy for of Melanoma
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