Breast Cancer Research Foundation

Criteria

Objectives:

The primary objective will be to determine whether patients receiving the combination of dendritic cells and high dose IL-2 (Cohort A) have sustained persistence of infused T cells compared to patients treated with T cells and high dose IL-2 alone.

Secondary endpoints will include evaluations for tumor response and studies to determine whether dendritic cells enhance the infused T cells in anti-tumor activity and their ability to migrate to the tumor site. In addition, we will evaluate the characteristics of the infused T cells that correspond with effectiveness in vivo.

Additionally, secondary objectives will include correlation of clinical parameters with survival (overall survival and progression-free survival) for all cohorts.

COHORT C

In a separate cohort (Cohort C) the primary endpoint will be the overall response rate of TIL treatment for patients who have not achieved PR or CR or have progressive disease from treatment of the BRAF inhibitor alone.

COHORT D

The primary objective of Cohort D is to confirm the safety of adoptively transferred, TIL into the CSF.

The secondary objective is the evaluation of clinical imaging and CSF response. Correlative objectives will assess if the intrathecally-infused T cells persist in the CSF, assess circulating tumor cells in the CSF, and assess various cytokine and other analyses,as feasible.

Inclusion Criteria:

  1. Signed Informed Consent Form

  2. Capable of giving informed consent.

  3. Ability and willingness to comply with the protocol including all scheduled MRI studies and paired tumor biopsies

  4. Aged ≥ 18 years.

  5. borderline or unresectable pancreatic adenocarcinoma without distant metastatic disease.

  6. ECOG PS of 0 or 1

  7. Must have adequate organ and hematopoietic function

  8. Female and Males must use an approved contraceptive method

Exclusion Criteria:

  1. Received prior therapy for pancreatic adenocarcinoma

  2. History of deep vein thrombosis (DVT) or pulmonary embolism (PE)

  3. Contraindication to therapeutic anticoagulation or heparin

  4. Intolerance to dexamethasone

  5. Contraindication to MRI or unwillingness to undergo all scheduled MRI exams

  6. Known or suspected brain metastasis

  7. Significant cardiovascular disease such as current New York Heart Associate Class III/IV heart failure, myocardial infarction or stroke within 6 months prior to enrollment

  8. A second primary malignancy that, in the judgment of the investigator, may affect the interpretation of results

  9. Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint

  10. Active bacterial or fungal infection requiring IV therapy at the start of protocol treatment

  11. Subjects may not receive concomitant anticancer agents or radiation.

  12. Female subjects who are pregnant or nursing

  13. Pre-existing peripheral neuropathy > CTCAE Grade 2.

  14. Known allergy to hyaluronidase

  15. Current use of megestrol acetate (use within 10 days of Day 1)

  16. Inability to comply with study and follow-up procedures as judged by the Investigator

https://clin.larvol.com/trial-detail/NCT00002681