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A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Micoenvironment in Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT03519308
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
The main purpose of this study is to look at the potential effects of paricalcitol (a drug similar to vitamin D) and nivolumab on pancreatic tumors in patients who are treated with gemcitabine and abraxane. The study will also look at the safety of including paricalcitol and nivolumab as part of the gemcitabine and abraxane chemotherapeutic regimen.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Nivolumab Drug: Nab-Paclitaxel Drug: Gemcitabine Drug: Paricalcitol Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Perioperative Nivolumab and Paricalcitol to Target the Micoenvironment in Resectable Pancreatic Cancer
Actual Study Start Date : August 4, 2017
Estimated Primary Completion Date : April 4, 2019
Estimated Study Completion Date : August 4, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A Drug: Nivolumab
Before Surgery Wks 1 &3, After Surgery Wks 1 &3

Drug: Nab-Paclitaxel
Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery

Drug: Gemcitabine
Wks 1,2,3 before surgery and Wks 1,2,3 after surgery

Drug: Paricalcitol
Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery

Experimental: Arm B Drug: Nivolumab
Before Surgery Wks 1 &3, After Surgery Wks 1 &3

Drug: Nab-Paclitaxel
Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery

Drug: Gemcitabine
Wks 1,2,3 before surgery and Wks 1,2,3 after surgery




Primary Outcome Measures :
  1. Numer of Adverse Events [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previously untreated, apparently resectable adenocarcinoma of the pancreas at registration.
  • Age greater than or equal to 18 years
  • ECOG performance status of 0-2.
  • Standard laboratory criteria for hematologic, biochemical, and urinary indices within a range that, in the opinion of the physician, clinically supports enrollment of the subject on the trial.

    a. Note: subjects must have: Creatinine < 2xULN, Neutrophils >1.5x109/L, total bilirubin < 3xULN, AST <5xULN, ALT <5xULN, and Platelets >100,000/mm3

  • Ability to provide written informed consent

Exclusion Criteria:

  • Subjects with hypercalcemia (blood levels greater than 11.5 mg/dL). In subjects creatinine clearance <60mL/min, blood calcium levels must be 9.5 mg/dL or lower.
  • Subjects who are currently pregnant, planning to become pregnant, or breast-feeding

    1. Females participants of child-bearing potential are required to use an effective contraception method (see Appendix A) or abstain from intercourse during treatment and for at least 5 months following the last dose
    2. Males participants with partners of child-bearing potential are required to use an effective contraception method (see Appendix A) or abstain from intercourse during treatment and for at least 5 months following the last dose 3. Subjects who, in the opinion of the physician, would not be clinically appropriate for receipt of the therapy regimen associated with participation 4. Subjects with contraindications to immune checkpoint therapy, as follows:
    1. Interstitial lung disease that is symptomatic or may interfere with the detection and management of suspected drug-related pulmonary toxicity
    2. Prior organ allograft or allogeneic bone marrow transplantation
    3. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
    4. Active autoimmune disease, except for vitiligo, type 1 diabetes mellitus, asthma, atopic dermatitis, or endocrinopathies manageable by hormone replacement; other autoimmune conditions may be allowable at the discretion of the principal investigator
    5. Condition requiring systemic treatment with either corticosteroids

      • Systemic steroids at physiologic doses (equivalent to dose of oral prednisone 10 mg) are permitted. Steroids as anti-emetics for chemotherapy are strongly discouraged (see section 5.1.3)
      • Intranasal, inhaled, topical, intra-articular, and ocular corticosteroids with minimal systemic absorption are permitted

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519308


Contacts
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Contact: Peter O'Dwyer, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Peter O'Dwyer, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Peter O'Dwyer, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Peter O'Dwyer, MD Abramson Cancer Center of the University of Pennsylvania

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03519308     History of Changes
Other Study ID Numbers: UPCC 22217
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ergocalciferols
Gemcitabine
Nivolumab
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Immunological
Calcium-Regulating Hormones and Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents