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Epithelial Ovarian CancerPhase 1NCT02480374

Study of Safety & Biological Activity of IP IMNN-001 (also Known As GEN-1) with Neoadjuvant Chemo in Ovarian Cancer

A Phase 1 study testing IMNN-001 in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Imunon at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This dose escalation study will determine a maximum tolerated dose and/or optimal biological dose of GEN-1 for carboplatin/paclitaxel combination in newly diagnosed ovarian cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
IMNN-001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
4 sitesUnited States
Study dates
Sep 2015to May 2017
Phase
Phase 1
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 histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.
  • Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).
  • Patients must have adequate:
  • Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.
  • Renal function: Creatinine ≤ 1.5 x institutional upper limit normal (ULN). iii. Hepatic function: Bilirubin ≤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN.
  • Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.
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  • Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.
  • Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.
  • Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.
  • Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.
  • Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.
  • Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.
  • Patients must be at least 18 years old.

Who cannot join

  • Patients who have received prior treatment with IMNN-001.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.
  • Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy not related to chemotherapy administration.
  • Patients receiving treatment for active autoimmune disease. "Active" refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.
  • Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol 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.
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
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  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
  • Patients with known active hepatitis.
  • Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
  • Patients of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.
  • Patients with history or evidence upon physical examination of CNS disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or subarachnoid hemorrhage within six months of the first date of treatment on this study.
  • Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within 4 weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Alabama Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Medical College of Wisconsin/Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Washington Univ. in St. Louis/Barnes Jewish Hospital

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: A Phase I Study of the Safety and Biological Activity of Intraperitoneal IMNN-001 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Standard Neoadjuvant Chemotherapy in Patients Newly Diagnosed with Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

This dose escalation study will determine a maximum tolerated dose and/or optimal biological dose of GEN-1 for carboplatin/paclitaxel combination in newly diagnosed ovarian cancer.

Being tested
IMNN-001
Keywords
GEN-1, IMNN-001
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms

What participants receive

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

  • IMNN-001Biological

    Also called GEN-1

Study groups in NCT02480374
Study groupRoleWhat they receive
Single ArmExperimentalCarboplatin + Paclitaxel + IMNN-001
Receives: Biological: IMNN-001

What is being measured

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

  1. DLT

    Dose-limiting toxicity

    Measured: 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 posted24 Jun 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionMay 2017
  4. Study completionMay 2017

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02480374
Sponsor's protocol ID
201-14-101
Status last verified
Oct 2024
First submitted
22 Jun 2015
Last updated
2 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yin X, Davi R, Lamont EB, Thaker PH, Bradley WH, Leath CA 3rd, Moore KM, Anwer K, Musso L, Borys N. Historic Clinical Trial External Control Arm Provides Actionable GEN-1 Efficacy Estimate Before a Randomized Trial. JCO Clin Cancer Inform. 2023 Jan;7:e2200103. doi: 10.1200/CCI.22.00103.

    PubMed 36608308

  • Gonzalez-Junca A, Liu FD, Nagaraja AS, Mullenix A, Lee CT, Gordley RM, Frimannsson DO, Maller O, Garrison BS, Iyer D, Benabbas A, Truong TA, Quach A, Tian M, Martinez R, Savur R, Perry-McNamara A, Nguyen D, Almudhfar N, Blanco C, Huynh C, Nand A, Lay YE, Magal A, Mangalampalli S, Lee PJ, Lu TK, Lee G. SENTI-101, a Preparation of Mesenchymal Stromal Cells Engineered to Express IL12 and IL21, Induces Localized and Durable Antitumor Immunity in Preclinical Models of Peritoneal Solid Tumors. Mol Cancer Ther. 2021 Sep;20(9):1508-1520. doi: 10.1158/1535-7163.MCT-21-0030. Epub 2021 Jul 1.

    PubMed 34210826

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMNN-001 in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Imunon at 4 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 13 inclusion and 12 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: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 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.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

DLT (time frame: 4 weeks). 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 NCT02480374, which also lists 2 linked publications.

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 2 Oct 2024.

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