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Stage II Fallopian Tube Cancer AJCC v8Phase 1/2NCT03735589

Specialized Immune Cells (nCTLs) and a Vaccine (Alpha-type-1 Polarized Dendritic Cells) in Treating Patients With Stage II-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Phase 1/2 study testing Alpha-type-1 Polarized Dendritic Cells and Autologous Natural Killer Cell-like CTLs in people with Stage II Fallopian Tube Cancer AJCC v8 and Stage II Ovarian Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I/IIa trial studies the side effects and best dose of a type of specialized immune cell (natural killer cell-like cytotoxic T-lymphocytes (CTLs) (nCTLs) and how well they work when given with a vaccine (alpha-type-1 polarized dendritic cells) in treating patients with stage II-IV ovarian, fallopian tube, or… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Alpha-type-1 Polarized Dendritic Cells and Autologous Natural Killer Cell-like CTLs
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
15 Dec 2023to 1 Dec 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

  • Eligible patients will be women with stages II-IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma with no radiologic evidence of disease (NED) or minimal disease burden after 1st line therapy. These patients would normally enter a period of observation after standard management.
  • Life expectancy > 6 months.
  • Have been informed of other treatment options.
  • Patients must be reasonable candidates for intraperitoneal (IP) port placement with no prior evidence of persistent abdominal wall or intraperitoneal infections, renal toxicity, or bowel obstruction or fistula.
  • Patients must have documented available tumor: at least 1 cm of bulk tumor mass collected at the time of primary or interval debulking surgery. The specimen may be obtained on this protocol or as part of other Institutional Review Board (IRB) approved tumor banking protocols.
  • Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI]).
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  • Must have adequate venous access for apheresis. (Pheresis catheter placement for cell collection is allowed).
  • Patient must agree to leukapheresis.
  • Patients must agree to appropriate clinical monitoring to receive the study regimens.
  • Absolute neutrophil count (ANC) greater than or equal to 1,000/uL.
  • Platelets greater than or equal to 75,000/uL.
  • Hemoglobin greater than or equal to 8.0 g/dL.
  • Creatinine less than or equal to 2 x institutional upper limit normal (ULN).
  • Bilirubin less than or equal to 1.5 x ULN.
  • Serum glutamic oxaloacetic transaminase (SGOT) less than or equal to 3 x ULN.
  • Alkaline phosphatase less than or equal to 3 x ULN.
  • Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
  • Female subjects must either be of non-reproductive potential (i.e., post-menopausal by history: >= 50 years old and no menses for >= 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative urine or serum pregnancy test within 28 days of study treatment, confirmed prior to treatment.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Who cannot join

  • Metastatic disease to the central nervous system and any site above diaphragm.
  • Other serious illnesses (e.g., serious infections requiring antibiotics [with the exception of uncomplicated UTI], bleeding disorders).
  • Chemotherapy, radiation therapy, or immunotherapy within 4 weeks prior to first dosing of study agent. Concomitant hormonal therapies are allowed.
  • 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) requiring chronic use of steroids or other immunosuppressives.
  • Patients being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic chronic corticosteroids. NOTE: Recent or current use of inhaled steroids is not exclusionary.
  • Use of chronic corticosteroids, hydroxyurea, or immunomodulating agents (e.g., interleukin 2, interferon alpha or gamma, granulocyte colony stimulating factors, etc.) within 30 days prior to study entry.
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  • NOTE: Recent or current use of inhaled steroids is not exclusionary. If subjects are prescribed a brief course of oral steroids, the use should be limited to less than 7 days. Use of steroids before apheresis and immune assessment blood draws will affect white blood cell function (wash out period of 1 week).
  • Patients with a known immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, or congenital immunodeficiencies. Specific testing is not required, however may be done as clinically indicated.
  • Patients with uncontrolled diseases other than cancer may be excluded if after consultation with PI and research team it is decided it might affect the treatment efficacy or toxicity..
  • Patients with tumors of low malignant potential, except ovarian pseudomyxoma or with no peritoneal disease at initial diagnosis.
  • Patients with a history of other invasive malignancies, with the exception of nonmelanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
  • Evidence of current drug or alcohol abuse or psychiatric impairment, which in the investigator's opinion will prevent completion of the protocol therapy or follow-up. Specific testing is not required, however may be done as clinically indicated.
  • Any condition that in the opinion of principal investigator (PI) would preclude patient from successfully completing the protocol therapy or follow-up.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

Other trials in United States

About this study

Official title: A Phase I/IIa Safety and Immunologic Efficacy Trial of Intraperitoneal Induction of CTLs Combined With Alpha-Dendritic Cell Vaccine for Primary Ovarian Cancer

This phase I/IIa trial studies the side effects and best dose of a type of specialized immune cell (natural killer cell-like cytotoxic T-lymphocytes (CTLs) (nCTLs) and how well they work when given with a vaccine (alpha-type-1 polarized dendritic cells) in treating patients with stage II-IV ovarian, fallopian tube, or primary peritoneal cancer. nCTLs are immune cells that are isolated from each patient?s blood and "taught" in the laboratory how to recognize and eliminate tumor cells. These "educated" immune cells are then given back to the patient. An alpha-type-1 polarized dendritic cell vaccine is another population of "educated" immune cells that work to support the infused nCTLs. Giving nCTLS with a dendritic cell vaccine may work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

Read the detailed description

PRIMARY OBJECTIVES I. To evaluate the safety, tolerability, and feasibility of intraperitoneal (i.p.) administration of autologous tumor loaded DC vaccines (alpha-type-1 polarized dendritic cell [alphaDC1]) combined with intradermally administered aDC1 .(Safety [Phase I aspect]) II. To measure the intraperitoneal induction and persistence of aDCI induced sensitized cytotoxic T Cells (CTLs), which express natural killer (NK) cell-like features (nCTLs) and total CTLs following intraperitoneal administration of aDC1. (Local Immunologic Efficacy [Phase II aspect])

SECONDARY OBJECTIVES I. To study the T cell populations generated that correlates with higher anti-tumor responses.

EXPLORATORY OBJECTIVES I. To evaluate the progression-free survival and overall survival of patients treated with this regimen.

OUTLINE: This is a phase I, dose-escalation study of nCTLs, followed by a phase IIa study.

Patients receive the alpha-type-1 polarized dendritic cell vaccine intradermally (ID) 2 weeks before day 0, on day 0, and on day 28. Patients also receive nCTLs intraperitoneally (IP) over 15-30 minutes on day 0. In the absence of unacceptable side effects, patients may receive the alpha-type-1 polarized dendritic cell vaccine every 1-3 months at the discretion of the physician.

After completion of study treatment, patients are followed up at 14 days, then at 6 and 12 months.

Being tested
Alpha-type-1 Polarized Dendritic Cells, Autologous Natural Killer Cell-like CTLs
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

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

  • Alpha-type-1 Polarized Dendritic CellsBiological

    Also called alphaDC1

    Given ID

  • Autologous Natural Killer Cell-like CTLsBiological

    Also called Autologous aDC1-induced CTLs, Autologous CTLs Sensitized Ex-vivo with Autologous TAA-loaded alphaDC1, Autologous Natural Killer-like Cytotoxic Lymphocytes, Autologous nCTLs

    Given IP

Study groups in NCT03735589
Study groupRoleWhat they receive
Treatment (nCTLs, alpha-DC1 vaccine)ExperimentalPatients receive the alpha-type-1 polarized dendritic cell vaccine ID 2 weeks before day 0, on day 0, and on day 28. Patients also receive aDC1 IP over 3-10 seconds on day 0. In the absence of unacceptable side effects, patients may receive the alpha-type-1 polarized dendritic cell vaccine every 1-3 months at the discretion of the physician.
Receives: Biological: Alpha-type-1 Polarized Dendritic Cells; Biological: Autologous Natural Killer Cell-like CTLs

What is being measured

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

  1. Incidence of adverse events as assessed by Cancer Therapy Evaluation Program (CTEP) version 4 of the Common Terminology Criteria for Adverse Events (CTCAE)

    Measured: Up to 12 months

  2. Dose-limiting toxicities (DLT) assessed by CTCAE version 5

    Will be used in the estimation of the maximum tolerated dose (MTD) and the accompanying of the dose escalation decisions. However, no formal analyses of DLTs are planned.

    Measured: Up to 14 days after intraperitoneal (IP) infusion of nCTLs

  3. Change in immune response

    Change in immune response will be measured by the increase in the number of CD3+CD8+NKG2D (high) natural killer cell-like cytotoxic T-lymphocyte (CTLs) (nCTLs) and the increase in total CD3+CD8+ CTLs recovered in the peritoneal washes with evaluation on day 0 versus day 2. The analysis will consist of an analysis-of-covariance (ANCOVA) for the outcome of post-pre ACT treatment cell count with a factor for dose and sampling time 48 hrs +/- 24 hrs.

    Measured: From baseline (day 0) to day 2 (48 hours after adoptive cell therapy [ACT]) administration

  4. Persistence of nCTLs after their adoptive transfer

    At day 0 will obtain peritoneal material (outflow and washes) directly before i.p. infusion of nCTLs, as well as day 2 (48 hours +/- 24 hours), day 7 (+/- 2 days), 2 weeks (14 days +/- 2 days) and 4 weeks (28 days +/- 3 days) later.

    Measured: Up to 4 weeks

Secondary outcomes (1)

  1. T cell populations and higher anti-tumor responses

    Will estimate the half-life of CD3/CD8/NKG2D (triple-positive nCTLs) cell counts and longitudinal changes CD3/CD8 cell counts (double-positive CTLs, which include both nCTLs and additional CTLs newly recruited CTLs from the circulation) cell counts as a function of dose and time. A nonlinear regression model with a random effect for subject (population pharmacokinetics [PK]) will be fit to a one-compartment kinetics first-order absorption model per dose level.

    Measured: Up to 4 weeks

Timeline

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

  1. First posted8 Nov 2018
  2. Study start15 Dec 2023 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2025 (estimated)

Why it stopped: new study to be created

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03735589
Sponsor's protocol ID
i 60417
Other IDs
NCI-2018-02337, i 60417, P50CA159981
Status last verified
Nov 2023
First submitted
7 Nov 2018
Last updated
22 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Alpha-type-1 Polarized Dendritic Cells and Autologous Natural Killer Cell-like CTLs in people with Stage II Fallopian Tube Cancer AJCC v8 and Stage II Ovarian Cancer AJCC v8, run by Roswell Park Cancer Institute at 1 site 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 19 inclusion and 13 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 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Incidence of adverse events as assessed by Cancer Therapy Evaluation Program (CTEP) version 4 of the Common Terminology Criteria for Adverse Events (CTCAE) (time frame: Up to 12 months). The study lists 4 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 NCT03735589.

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 22 Nov 2023.

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