Please Note : This study will be moving from the Phase I portion of the study into the Phase
II portion of the study with an Anticipated start date of September 1, 2020.
The main goal of this research study is to determine if intraperitoneal (IP) administration
of cisplatin in addition to an investigational vaccine (the DC vaccine) with or without an
investigational drug combination of IP rintatolimod, IP interferon alpha-2b (IFN), and oral
celecoxib, has any effect, good or bad, on recurrent ovarian cancer.
- Patients must have peritoneal recurrence of epithelial adenocarcinoma or
carcinosarcoma of ovarian, tubal, or peritoneal origin. Histologic documentation of
the original primary tumor is required via the pathology report. Original tumor blocks
from primary diagnosis will be reviewed by our study pathologist at Magee.
- Patients must have completed front-line taxane/platinum-based therapy of their primary
tumor with a progression free interval of greater than 6 months from last therapy and
measurable relapsed disease must be present in the abdomen greater than 1 cm.
- Patients must have documentation of a defined initial progression free interval (PFI
1) of greater than 6 months following front-line therapy.
- Patients must have documentation of relapse that includes either doubling of CA125
serum levels confirmed by measurements greater than one week apart or identification
of a new measurable lesion greater than 1 cm in the peritoneal cavity either by
CT/MRI, PET/CT scan or physical exam (expanding pockets of ascites fluid that may
serve as an alternative source of tumor cells) if the index lesion is not accessible
for biopsy for vaccine formulation. Recurrence outside the peritoneal cavity will be
accessed using standard RECIST criteria.
- Patients must be reasonable candidates for laparoscopy and IP platinum regimen with no
prior evidence of clinically significant intra-abdominal adhesions, persistent
abdominal wall infections, renal toxicity, or bowel obstruction.
- Prior to enrollment, the CA125 should have been elevated to at least double the level
seen at the nadir value following the first complete response and measurable
intraperitoneal disease that can be identified radiologically and accessed by
laparoscopy/laparotomy for a biopsy and peritoneal catheter placement.
- Patients must have documented available tumor greater than 1 cm of bulk tumor mass or
200 cc of ascites fluid for tumor isolation prior to starting chemotherapy.
- Patients of childbearing potential must have a negative pregnancy test prior to the
study entry and be practicing an effective form of contraception. If applicable,
patients must discontinue breastfeeding prior to the first date of treatment on this
- Patient may be required to undergo leukapheresis (depending on the study phase/cohort)
and must agree to leukapheresis if so assigned.
- Patients must agree to appropriate clinical monitoring to receive the study regimens.
- Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to
1,500/µL, equivalent to CTCAE v4 grade 1. Platelets greater than or equal to
100,000/µL; hemoglobin greater than or equal to 8.0 g/dL.
- Renal function: creatinine less than or equal to 1.5 x institutional upper limit
normal (ULN), CTCAE v4 grade 1.
- Hepatic function: Bilirubin less than or equal to 1.5 x ULN (CTCAE v4 grade 1). SGOT
and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v4 grade 1).
- Patients who have signed informed consent and authorization permitting release of
personal health information.
- Patients must be ≥ 18 years of age.
- Patients must have a GOG Performance Status of 0 or 1.
- Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic
lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis
(MS), ankylosing spondylitis).
- Patients with a known allergy to cisplatin chemotherapy. Patients with carboplatin
allergy may be included if they tolerate a test dose of IV cisplatin given in
monitored floor conditions.
- Patients being chronically treated with immunosuppressive drugs such as cyclosporin,
adrenocorticotropic hormone (ACTH), or systemic corticosteroids.
- Patients with a recognized immunodeficiency disease including cellular
immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have
acquired, hereditary, or congenital immunodeficiencies.
- Patients with uncontrolled diseases other than cancer will be excluded.
- Patients who are pregnant or nursing.
- Patients who have contraindications to the use of NSAID's like chronic renal failure,
coronary artery disease, or bleeding ulcers.
- Patients with tumors of low malignant potential, except ovarian pseudomyxoma or with
no peritoneal disease.
- Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last five years. Patients are also excluded if their previous
cancer treatment contraindicates this protocol therapy.
- Patients with previous pelvic radiation therapy.