Adoptive cell therapy across cancer diagnoses

Phase 1

• Conditions: Patients with metastatic solid cancers in stages III or IV regardless of diagnosis.; MedDRA version: 20.0Level: PTClassification code 10055099Term: Ocular cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10055100Term: Otic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10055108Term: Thymic cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10050017Term: Lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10059514Term: Small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10055104Term: Pharyngeal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10055105Term: Sinus cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10055096Term: Anal cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2017-002323-25-DK
• Lead Sponsor: Center for cancer immune therapy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-27
• Last Update Posted: 9 October 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

oHistologically verified cancer diagnosis
oMetastatic disease and at least one lesion (>1 cm3) available for surgical resection
oLate stage disease (III-IV) without effective standard treatment options
oAge of 18-70 years
oECOG performance status of 1 or 0. For information see appendix 2.
oLife expectancy > 6 months
oOne or more measurable parameter in according to RECIST 1.1.
oNo significant toxicity from previous cancer treatments (CTC=1). Except alopleica (CTC=2) or neuropathy (CTC=2)
oSufficient organ function, including:
oAbsolute neutrophil count (ANC) = 1.500 /µl
oLeucocyte count = normal limit
oPlatelets = 100.000 /µl and <700.000 /µl
oHemoglobin = 6,0 mmol/l (regardless of prior transfusion)
oS-creatinine < 140
oS-bilirubin = 1,5 times upper normal limit
oASAT/ALAT = 2,5 times upper normal limit
oAlkaline phosphatase = 5 times upper normal limit
oLactate dehydrogenase = 5 times upper normal limit
oSufficient coagulation: PP-time>40 and INR<1,5
oWomen 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.
oSigned statement of consent after receiving oral and written study information
oWillingness to participate in the planned controls and capable of handling toxicities.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

oA history of prior malignancies. Patients treated for another malignancy can only participate if they are without signs of disease for a minimum of 5 years after last treatment.
oPrimary brain tumor or signs of brain metastases
oKnown hypersensitivity to one of the active drugs or excipients.
oSevere medical conditions, such as severe asthma/COLD, significant cardiac disease, poorly regulated insulin dependent diabetes mellitus among others.
oCreatinine clearence below 70 ml/min .
oAcute or chronic infections with HIV, hepatitis, syphilis etc.
oSevere allergies or previous anaphylactic reactions.
oActive autoimmune disease, such as autoimmune neutropenia/thrombocytopenia or hemolytic anemia, systemic lupus erythematosus, Sjögren’s syndrome, sclerodermia, myasthenia gravis, goodpasteures disease, addison’s disease, hashimoto’s thyroiditis, graves’ disease etc.
oPregnant women and women who are breastfeeding.
oSimultaneous treatment with systemic immunosuppressive drugs (including prednisolone methotrexate etc.)
oSimultaneous treatment with other experimental drugs.
oSimultaneous treatment with other systemic anti-cancer treatments.
oPatients with active or uncontrollable hypercalcemia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified