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AzTrials

Cancer of OvaryPhase 1/2NCT02432378

Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines

A Phase 1/2 study testing Cisplatin + celecoxib + DC vaccine and Cisplatin + CKM + Celecoxib + DC Vaccine in people with Cancer of Ovary and Cancer of the Ovary, run by Roswell Park Cancer Institute at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cisplatin + celecoxib + DC vaccine and Cisplatin + CKM + Celecoxib + DC Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesUnited States
Study dates
4 Sep 2015to 19 Jun 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have advanced stage (III-IV) epithelial carcinoma 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 biopsy will be reviewed by our study pathologist at Magee.
  • Patients must be receiving neoadjuvant chemotherapy
  • Patients must be eligible for cancer-related definitive therapy with neoadjuvant chemotherapy
  • Patients must be chemonaive and receiving therapy in primary first line neoadjuvant setting
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  • Patients must have GOG performance of 0-1
  • Patients must be reasonable candidates for interval debulking surgery as well as IP platinum based combination chemotherapy regimen with no prior evidence of clinically significant intra-abdominal adhesions, persistent abdominal wall infections, renal toxicity, or bowel obstruction.
  • 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 study.
  • Patient must be willing to undergo leukapheresis
  • Patients must agree to appropriate clinical monitoring to receive the study regimens.
  • Patient must have:
  • 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 have a GOG Performance Status of 0 or 1.

Who cannot join

  • 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 or taxane chemotherapy. Patients with carboplatin allergy may be included if they tolerate a test dose of IV cisplatin given in monitored floor conditions. Patients who are allergic to paclitaxel, can be alternatively treated with abraxane.
  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UPMC CancerCenter at Magee-Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

Other trials in United States

About this study

Official title: A PHASE 2 EFFICACY TRIAL OF INTENSIVE LOCOREGIONAL CHEMOIMMUNOTHERAPY FOR ADVANCED STAGE OVARIAN CANCER AND TUMOR-SPECIFIC INTRANODAL AUTOLOGOUS ALPHA-DC1 VACCINES

This study will evaluate the immunologic and potential clinical effectiveness of intensive locoregional sequential intraperitoneal (IP) cisplatin (IPC) with intravenous (iv) paclitaxel followed by peritoneal infusion of a chemokine modulatory (CKM) regimen composed of a cocktail of IP rintatolimod and interferon-alpha (IFNα) for patients with advanced stage ovarian cancer (III-IV) at primary neoadjuvant setting.

In the safety phase I phase, we determined the tolerable dose of IPC-CKM. In this phase 2 we will add intradermal (ID) autologous αDC1 vaccines (known to be nontoxic) to the tolerable IPC-CKM regimen. The effectiveness will be determined by rate of complete pathologic response.

Read the detailed description

On Phase 1, patients received up to 6 cycles of IPC, with CKM after the 2nd to 6th cycles. On Phase 2, (which opened 8/27/24/ )patients will receive up to 6 -8 cycles of chemotherapy with ID injections of DC1 vaccine with CKM. To optimize the pattern of immunity, all patients will also receive oral celecoxib (COX2 inhibitor).

Being tested
Cisplatin + celecoxib + DC vaccine, Cisplatin + CKM + Celecoxib + DC Vaccine
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cisplatin + celecoxib + DC vaccineBiological

    Cisplatin 50 mg/m2 by IP once per cycle (21 days) + celecoxib daily 200 mg by mouth daily + intranodal vaccine injections once per cycle

  • Cisplatin + CKM + Celecoxib + DC VaccineBiological

    Cisplatin 50 mg/m2 by IP once per cycle (21 days) + celecoxib daily 200 mg by mouth daily + IFN by IP once per cycle + rintatolimod 200 mg by IP once per cycle + intranodal vaccine injections once per cycle

Study groups in NCT02432378
Study groupRoleWhat they receive
Cisplatin + Celecoxib + DC VaccineExperimentalCisplatin 50 mg/m2 by IP once per cycle (21 days) + celecoxib daily 200 mg by mouth daily + intranodal vaccine injections once per cycle
Receives: Biological: Cisplatin + celecoxib + DC vaccine
Cisplatin + CKM + Celecoxib + DC VaccineExperimentalCisplatin 50 mg/m2 by IP once per cycle (21 days) + celecoxib daily 200 mg by mouth daily + IFN by IP once per cycle + rintatolimod 200 mg by IP once per cycle + intranodal vaccine injections once per cycle
Receives: Biological: Cisplatin + CKM + Celecoxib + DC Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the number of CD8+ tumor infiltrating T cells in the peritoneal fluid.

    The difference in CD8+ tumor infiltrating T cells over 3 cycles of platinum based chemotherapy plus immunotherapy compared with baseline.

    Measured: 8 weeks

  2. Number of adverse events for the different combinations

    2 patients will be treated and observed for 2 cycles on each of the dose tiers to identify the acceptable dose of IFN in combination with the other protocol drugs/vaccine for the second phase of the trial.

    Measured: 8 weeks

Secondary outcomes (5)

  1. Change in the number of CD3+CD8+ T cells in the peritoneal fluid.

    Measured: 8 weeks

  2. Change in the number of effector CD8+ T cells in the peritoneal fluid.

    Measured: 8 weeks

  3. Change in the number of CD4+ T cells in the peritoneal fluid.

    Measured: 8 weeks

  4. Change in the number of Tregs in the peritoneal fluid.

    Measured: 8 weeks

  5. Change in the number of myeloid-derived suppressor cells in the peritoneal fluid.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 May 2015 (estimated)
  2. Study start4 Sep 2015
  3. Primary completion19 Jun 2025
  4. Study completion19 Jun 2025

Why it stopped: opening up at a different site

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02432378
Sponsor's protocol ID
UPCI 11-128/IC 3050822
Other IDs
5P01CA132714
Status last verified
Jul 2026
First submitted
8 Apr 2015
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Orr B, Mahdi H, Fang Y, Strange M, Uygun I, Rana M, Zhang L, Suarez Mora A, Pusateri A, Elishaev E, Kang C, Tseng G, Gooding W, Edwards RP, Kalinski P, Vlad AM. Phase I Trial Combining Chemokine-Targeting with Loco-Regional Chemoimmunotherapy for Recurrent, Platinum-Sensitive Ovarian Cancer Shows Induction of CXCR3 Ligands and Markers of Type 1 Immunity. Clin Cancer Res. 2022 May 13;28(10):2038-2049. doi: 10.1158/1078-0432.CCR-21-3659.

    PubMed 35046055

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cisplatin + celecoxib + DC vaccine and Cisplatin + CKM + Celecoxib + DC Vaccine in people with Cancer of Ovary and Cancer of the Ovary, run by Roswell Park Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the number of CD8+ tumor infiltrating T cells in the peritoneal fluid. (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02432378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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