Clinical trial · Interventional
αDC1 Vaccine + Chemokine Modulatory Regimen (CKM) as Adjuvant Treatment of Peritoneal Surface Malignancies
A Phase 1/2 Trial Evaluating αDC1 Vaccines Combined With Tumor-Selective Chemokine Modulation as Adjuvant Therapy After Surgical Resection of Peritoneal Surface Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Pancreas Metastatic to Peritoneal Surface | Peritoneal Neoplasm | PROBABILISTIC | 0.70 |
| Malignant Peritoneal Mesothelioma | Peritoneal Malignant Mesothelioma | ALIAS | 0.90 |
| Peritoneal Carcinomatosis | Peritoneal Carcinomatosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Celecoxib | Drug | Celecoxib | ALIAS |
| DC vaccine | Biological | — | UNRESOLVED |
| Interferon Alfa-2b | Drug | Interferon Alfa-2b | ALIAS |
| rintatolimod | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Biological: DC vaccine
- Drug: Celecoxib
- Drug: Interferon Alfa-2b
- Biological: rintatolimod
Primary outcomes (2)
- measure
- Recommended Phase 2 Dose (RP2D) (Phase 1)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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