αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies

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Brief Title

αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies

Official Title

A Phase 1/2 Trial Evaluating αDC1 Vaccines Combined With Tumor-Selective Chemokine Modulation as Adjuvant Therapy After Surgical Resection of Peritoneal Surface Malignancies

Brief Summary

      This trial is to determine the safest dose of a triple combination (chemokine modulatory
      regimen or CKM) of celecoxib, interferon alfa (IFN), and rintatolimod that can be given with
      a DC vaccine as treatment of peritoneal surface malignancies after standard of care surgery.

      The first phase of this study will determine the safest dose of IFN that can be given in
      combination with celecoxib and rintatolimod along with a DC vaccine. The doses of celecoxib
      (400 mg) and rintatolimod (200 mg) will be consistent while the dose of IFN will be increased
      (5, 10, or 20 MU/m2) as participants are enrolled to the trial. The high dose of IFN in
      combination with celecoxib and rintatolimod will be used for the next phase of the clinical
      trial. After surgery, participants will receive 2 cycles of the investigational treatment.

      The second phase of this study will test if the investigational treatment has any effects on
      peritoneal surface malignancies. The doses of the combination determined in the first phase
      will be used in this phase of the clinical trial. After surgery, participants will receive 2
      cycles of the investigational treatment, followed by standard chemotherapy as determined by
      their oncologist, and then 2 more cycles of the investigational treatment.
    

Detailed Description

      This trial will evaluate the safety and effectiveness of autologous alpha-type-1 polarized
      dendritic cell (alpha-DC1) vaccines (patients' autologous alpha-DC1s loaded with autologous
      tumor material), combined with a systemic chemokine modulation regimen [CKM; intravenous
      rintatolimod (TLR3 ligand, a derivative of Poly-I:C) + intravenous interferon-alfa + oral
      celecoxib] as adjuvant therapy, after cytoreductive surgery (CRS) and hyperthermic
      intraperitoneal chemotherapy (HIPEC), in patients with peritoneal surface malignancies (PSM),
      including but not limited to malignant peritoneal mesothelioma and peritoneal carcinomatosis
      (PC) of appendiceal and colorectal origin.

      All patients judged to have peritoneal surface malignancy and considered able to be
      cytoreduced to Peritoneal Cancer Index (PCI) Completeness of Cytoreduction (CC) score of 1 or
      less will undergo CRS + HIPEC. Postoperative immunotherapy will start at least 4 weeks after
      CRS + HIPEC.

      Immunotherapy regimen will include four cycles of intranodal (3M cells) and intradermal (3M
      cells) αDC1 vaccines. Each booster αDC1 vaccine dose (treatment cycles 2-4) will be followed
      by 4-days of systemic CKM, starting the day after vaccination (IFNα [dose-escalation: 5-20
      MU/m2], intravenous [IV], once a day for 4 days; rintatolimod [short-half-life TLR3 ligand]
      200 mg intravenous [IV], on Wednesday and Friday only of the CKM regimen; and celecoxib 200
      mg, orally, twice a day for 4 days). In order to avoid overlap between experimental
      immunotherapy and potential adjuvant chemotherapy (which can be clinically indicated as a
      part of standard care in the subset of patients), the experimental treatments will be
      interrupted after cycles 1 and 2, to allow adjuvant chemotherapy that is done for each
      patient's clinical care, and is not a part of this research study. Whenever clinically
      indicated as a part of standard care, adjuvant chemotherapy may start at least 5 days after
      completion of the 2nd cycle of immunotherapy (first booster vaccine plus the first CKM). The
      3rd cycle of immunotherapy may start at least 5 days after the completion of chemotherapy.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

Recommended Phase 2 Dose (RP2D) (Phase 1)

Secondary Outcome

 Time to Progression (TTP)

Condition

Malignant Neoplasm of Pancreas Metastatic to Peritoneal Surface

Intervention

DC vaccine

Study Arms / Comparison Groups

 vaccine + chemokine modulatory regimen
Description:  Week 1 (at recovery from surgery; ≥ 6 weeks post-surgery)-Priming Vaccine dose; no chemokine modulation; 1 day: αDC1 vaccine; Oral celecoxib, 200 mg, before & after treatment on day of vaccination; Weeks 2-3 -Rest; Week 4 (target) - Booster C1; Mon: αDC1 vaccine;Tues - Fri: Systemic Chemokine Modulation Regimen. Oral celecoxib, 200 mg, BID on vaccination days & CKM. Celecoxib will be dced after CKM on Fri. Rintatolimod only administered on Wed & Fri.; Week 5-7 -Rest; Week 8 (target) -Booster C2; Monday: αDC1 vaccine. Oral celecoxib, 200 mg, BID on days of vaccination and CKM. Tues - Fri:Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed & Fri. Celecoxib will be dced after CKM on Fri.; Week 9-11 -Rest; Week 12 (target) -Booster C3; Monday: αDC1 vaccine. Tues-Fri: Systemic Chemokine Modulation Regimen. Rintatolimod only administered on Wed & Fri. Oral celecoxib, 200 mg, BID, given on days of vaccination and CKM. Celecoxib will be discontinued after CKM on Fri.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

64

Start Date

July 2014

Completion Date

February 18, 2019

Primary Completion Date

February 18, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with histologically confirmed peritoneal surface malignancies, including but
             not limited to malignant peritoneal mesothelioma and peritoneal carcinomatosis (PC)
             from presumed appendiceal and colorectal primary tumors. Most patients will have
             received extensive prior treatments, due to the recurrent nature of PC. Prior
             therapies involve previous CRS, local and systemic chemotherapies. None of these prior
             treatments disqualifies the patient from receiving the protocol-mandated experimental
             treatment.

          -  Patients must be deemed able to undergo optimal cytoreductive surgery (CRS) defined as
             CC-score of 0 or 1 based on imaging.

        Cytoreduction is defined as the burden of residual disease nodules left at the end of
        surgery (CC-0: no visible disease; CC-1: residual tumor nodules ≤ 2.5 mm in size; CC-2:
        residual tumor nodules 2.5 mm - 2.5 cm in size; CC-3: residual tumor nodules > 2.5 cm in
        size).

          -  Patients may be enrolled in the study regardless of prior chemotherapy regimens

          -  An ECOG performance status of 0, 1 or 2

          -  Age equal to 18 years or older

          -  Patients must be able to understand and be willing to sign a written informed consent
             document

          -  Able to swallow pills

          -  Must have normal organ and marrow function as defined below:

        Platelet ≥ 75,000/µL Hemoglobin ≥ 9.0 g/dL Hematocrit ≥ 27.0% Absolute Neutrophil Count
        (ANC) ≥ 1500/µL WBC >2000/mm3 Creatinine < 1.5 x institutional upper limit of normal (ULN),
        OR Creatinine clearance ≥ 50 mL/min/1.73 m2 for patients with creatinine levels greater
        than 1.5 x ULN Total bilirubin ≤ 1.5 x ULN AST(SGOT) and ALT(SGPT) ≤ 2.5 X ULN

          -  Must be eligible for pheresis within 8 weeks of surgery

          -  Availability of sufficient number of tumor cells for cryopreservation and subsequent
             vaccine production

          -  Must have had HIPEC during surgery

          -  Must have a CC score of 0

        Exclusion Criteria:

          -  Infection of tumor tissue with pathogens resistant to radiation and fungizone

          -  Patients on systemic immunosuppressive agents, including steroids. Patients who are
             able to be removed from immunosuppressives at least 5 days prior to the first vaccine
             will be considered eligible.

          -  Patients with active autoimmune disease or history of transplantation. Patients with
             indolent or chronic autoimmune disease not requiring steroid treatment are considered
             eligible.

          -  Patients who are pregnant or nursing

          -  Patients experiencing a cardiac events (acute coronary syndrome, myocardial
             infarction, or ischemia) within the 3 months prior to accrual

          -  Patients with a New York Heart Association classification of III or IV

          -  Prior allergic reaction or hypersensitivity to celecoxib or NSAIDs
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

David L Bartlett, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02151448

Organization ID

12-110

Secondary IDs

5P01CA132714-05

Responsible Party

Sponsor-Investigator

Study Sponsor

David Bartlett

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

David L Bartlett, MD, Principal Investigator, University of Pittsburgh


Verification Date

July 2020