Cancer Clinical Trial
Official title:
Adoptive Cell Therapy Across Cancer Diagnoses
Verified date | August 2020 |
Source | Herlev Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will perform tumor-infiltrating lymphocyte (TIL)-based adoptive T-cell therapy in combination with checkpoint inhibition on cancer patients across all cancer diagnoses.
Status | Active, not recruiting |
Enrollment | 25 |
Est. completion date | September 30, 2020 |
Est. primary completion date | March 13, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Only patients within the Danish Healthcare system are eligible for enrollment. Inclusion Criteria: - Histologically verified metastatic or locally advanced cancer diagnosis - At least one lesion (>1 cm3) available for surgical resection - Not candidate for standard treatment options - Age of 18-70 years - Performance status of 1 or 0. - Life expectancy > 6 months - One or more measurable parameter according to RECIST 1.1. - No significant toxicity from previous cancer treatments (CTC=1). Except aloplecia (CTC=2) or neuropathy (CTC=2) - Sufficient organ function, including: - Absolute neutrophil count (ANC) = 1.500 /µl - Leucocyte count = normal limit - Platelets = 100.000 /µl and <700.000 /µl - Hemoglobin = 6,0 mmol/l (regardless of prior transfusion) - S-creatinine < 140 - S-bilirubin = 1,5 times upper normal limit - ASAT/ALAT = 2,5 times upper normal limit - Alkaline phosphatase = 5 times upper normal limit - Lactate dehydrogenase (LDH) = 5 times upper normal limit - Sufficient coagulation: PP-time>40 and INR<1,5 - Women in the fertile age must use effective contraception. This applies from inclusion and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered safe contraceptives. - Signed statement of consent after receiving oral and written study information - Willingness to participate in the planned treatment and follow-up and capable of handling toxicities. Exclusion Criteria: - A history of prior malignancies. Patients treated for another malignancy can only participate if they are without signs of disease for a minimum of 3 years after last treatment. - Primary brain tumor or verified brain metastases - Known hypersensitivity to one of the active drugs or excipients. - Significant medical conditions, including but not limited to severe asthma/COLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus. - Creatinine clearance below 70 ml/min . - Acute or chronic infections with HIV, hepatitis, syphilis etc. - Severe allergies or previous anaphylactic reactions. - Active autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, Sjögren's syndrome, sclerodermia, myasthenia gravis, goodpastures disease, addison's disease, hashimoto's thyroiditis, graves' disease etc. - Pregnant women and women who are breastfeeding. - Simultaneous treatment with systemic immunosuppressive drugs (including prednisolone methotrexate etc.) - Simultaneous treatment with other experimental drugs. - Simultaneous treatment with other systemic anti-cancer treatments. - Patients with active or uncontrollable hypercalcemia. |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Cancer immune Therapy (CCIT), Dept. of Hematology and dept. of Oncology | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Inge Marie Svane |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number and type of reported adverse events | Determine the safety of the administration of TIL therapy including checkpoint inhibitors, lymphodepleting chemotherapy and Interleukin-2 for patients with cancer by reporting adverse events according to CTCAE v. 4.0. | Up to 2,5 years from begin of study | |
Secondary | Treatment response, progressive disease | Clinical response in progression-free survival to treatment according to RECIST 1.1 | Up to 7 years from begin of study | |
Secondary | Treatment response, surival | Clinical response in terms of overall survival. | Up to 7 years from begin of study | |
Secondary | Treatment related immune response | Flow cytometry-based immunological evaluation of peripheral blood | 3 years from begin of study |
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