C-VISA BikDD: Liposome in Advanced Pancreatic Cancer

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Brief Title

C-VISA BikDD: Liposome in Advanced Pancreatic Cancer

Official Title

A Phase I Open-Label Dose Escalation Study to Assess the Safety and Tolerability of the BikDD Nanoparticle in Patients With Advanced Pancreatic Cancer

Brief Summary

      The goal of this clinical research study is to find the highest tolerable dose of BikDD
      nanoparticle that can be given to patients with advanced cancer of the pancreas. The safety
      of this drug will also be studied.
    

Detailed Description

      The Study Drug:

      BikDD is a modified gene product that is designed to make cancer cells destroy themselves.
      Delivering BikDD in a fat molecule (a BikDD nanoparticle) may improve the delivery of the
      gene product into the cells. This may help to stop or slow the growth of pancreatic cancer.
      This is the first study using BikDD nanoparticle in humans.

      Study Drug Dose Level:

      If you are found to be eligible to take part in this study, you will be assigned to a dose
      level of BikDD nanoparticle based on when you joined this study. Different dose levels of
      BikDD nanoparticle will be tested. Three (3) participants will be enrolled at each dose
      level. The first group of participants will receive a low dose level. Each new group will
      receive a higher dose level, if no intolerable side effects were seen. If intolerable side
      effects were seen, then the next group of participants will receive a lower dose. This will
      continue until the highest tolerable dose of BikDD nanoparticle is found.

      The dose of study drug that you receive will never be increased. However, if you have side
      effects, your dose of study drug may be lowered. Your doctor will discuss with you which dose
      you will receive.

      Study Drug Administration:

      There will be 28 days in each cycle. The study visit schedule is described below. In certain
      circumstances, with the permission of your doctor, the study visits may occur up to 2 or 3
      days earlier or later than described below.

      On Days 1, 8, 15, 22 of each cycle, you will receive BikDD nanoparticle through a needle in
      your vein over about 10 minutes.

      Study Visits:

      Liver Tumor Biopsy:

      Before you receive the study drug, you will have a biopsy of the liver tumor. Researchers
      will compare this biopsy with a later biopsy to learn if the BikDD nanoparticle will be able
      to reach the tumor and what effect it is having on the cancer.

      You will be awake during the biopsy. A radiologist will find the tumor with the help of a
      scan such as an ultrasound or CT scan. You will receive a local anesthetic. A needle will be
      inserted through the skin into the tumor, and tissue sample(s) will be taken. You will
      receive fluids and drugs for relaxation and/or pain as needed through a needle in your arm or
      hand.

      On Days 1, 8, 15, 22 of Cycle 1, the following tests and procedures will be performed:

        -  You will have a physical exam, including measurement of your weight.

        -  Your vital signs will be measured 5 times.

        -  Your performance status will be recorded.

        -  You will be asked about any drugs and/or supplements you are taking or have taken since
           your last visit.

        -  You will be asked about any side effects you may be experiencing.

        -  Blood (about 2-3 tablespoons) will be drawn for routine tests.

        -  On Day 1 only, blood (about 2 teaspoons each time) will be drawn 9 times for
           pharmacokinetic (PK) testing. PK testing measures the amount of study drug in the body
           at different time points.

      On Day 2 of Cycle 1, blood (about 2 teaspoons) will be drawn 1 time for PK testing.

      On Days 4, 11, 18, and 25 of Cycle 1, the following tests and procedures will be performed:

        -  Blood (about 2-3 tablespoons) will be drawn for routine tests.

        -  You will be asked about any side effects you may be having.

      On Day 24 of Cycle 1, you will have a biopsy of the liver tumor to learn if BikDD
      nanoparticle is reaching the tumor and its effect on cancer. If for any reason the biopsy
      can't be performed then, you may be asked to have the biopsy 6-8 days later.

      On Day 1 of Cycle 2, the following tests and procedures will be performed:

      Your medical history will be recorded, including any drugs and/or supplements you are taking
      or have taken since your last visit.

        -  You will have a physical exam, including measurement of your weight.

        -  Your vital signs will be measured 5 times.

        -  Your performance status will be recorded.

        -  You will be asked about any side effects you may be experiencing.

        -  Blood (about 2-3 tablespoons) and urine will be collected for routine tests.

        -  You will have an ECG.

      On Days 8, 15, and 22 of Cycle 2, the following tests and procedures will be performed:

        -  Blood (about 1 tablespoon) will be drawn for routine tests.

        -  Your vital signs will be measured 5 times.

        -  You will be asked about any side effects you may be experiencing.

      At the end of Cycle 2 and every other cycle (Cycle 4, 6, 8, and so on), you will have a CT
      scan or MRI of the chest, abdomen, and pelvis to check the status of the disease. Blood
      (about 1 teaspoon) will be drawn to measure your CA 19-9 level. Because it may take some time
      for the effects BikDD may have on the tumor to be known, the study doctor may decide to
      continue the BikDD even if the scan/MRI shows the tumor is worse. In this case, you will have
      another CT scan or MRI of the chest, abdomen, and pelvis 4 to 6 weeks later. If the cancer is
      worse, you will stop BikDD.

      On Day 1 of Cycles 3 and beyond, the following tests and procedures will be performed:

        -  Your medical history will be recorded, including any drugs and/or supplements you are
           taking or have taken since your last visit.

        -  You will have a physical exam, including measurement of your weight.

        -  Your vital signs will be measured 5 times.

        -  Your performance status will be recorded.

        -  You will be asked about any side effects you may be experiencing.

        -  You will have an ECG.

        -  Blood (about 2-3 tablespoons) and urine will be collected for routine tests.

      On Days 8, 15, and 22 of Cycles 3 and beyond, the following tests and procedures will be
      performed:

        -  Your vital signs will be measured 5 times.

        -  You will be asked about any side effects you may be experiencing.

        -  Blood (about 2-3 tablespoons) will be drawn for routine tests.

      Length of Study:

      You may continue to receive the study drug as long as your doctor thinks it is in your best
      interest. If all of the cancer disappears, you will receive 2 extra cycles of study drug and
      then stop study drug. You will be taken off study if the disease gets worse, your doctor
      decides that it is in your best interest to stop the drug, or if you experience intolerable
      side effects.

      End-of-Study Visit:

      Once you stop the study drug for any reason, you will have an end-of-study visit. At this
      visit, the following tests and procedures will be performed.

        -  Your medical history will be recorded, including any drugs and/or supplements you are
           taking or have taken since your last visit.

        -  You will have a physical exam, including measurement of your weight and vital signs

        -  Your performance status will be recorded.

        -  You will be asked about any side effects you may be experiencing.

        -  You will have an ECG.

        -  Blood (about 2-3 tablespoons) and urine will be collected for routine tests and to
           measure your CA 19-9 level.

        -  If you have not had one within the last 4 weeks, you will have a CT scan or MRI of the
           chest, abdomen, and pelvis to check the status of the disease

      Once a week for at least 30 days after your last dose of study drug, you will be asked if you
      are experiencing any side effects. If you do not have a clinic visit already scheduled, you
      will be called. If you are called, it will take about 5-10 minutes.

      If you experience any side effects, you may continue follow-up visits until the medical
      problem has gone away or stabilized.

      Follow-Up:

      Every 2 months from then on, the study staff will continue to see how you are doing, either
      at a routine clinic visit or by phone. If you are called, it will last about 5-10 minutes. If
      you move, you will also be asked to provide your new address and telephone number to your
      doctor.

      This is an investigational study. BikDD nanoparticle is not FDA approved or commercially
      available. At this time, BikDD nanoparticle is only being used in research.

      Up to 30 patients will take part in this study. All will be enrolled at M D Anderson.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum Tolerated Dose (MTD) of BikDD Nanoparticle in Patients with Advanced Pancreatic Cancer


Condition

Pancreatic Cancer

Intervention

BikDD Nanoparticle

Study Arms / Comparison Groups

 BikDD Nanoparticle
Description:  BikDD Nanoparticle starting dose 0.04 mg/kg once weekly by vein over 10 minutes.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Genetic

Estimated Enrollment

0

Start Date

March 2015

Completion Date

March 2017

Primary Completion Date

March 2017

Eligibility Criteria

        Inclusion Criteria:

          1. Patients must have histologically or cytologically confirmed advanced pancreatic
             adenocarcinoma that is unresectable or metastatic.

          2. Patient must have received prior gemcitabine or a regimen containing oxaliplatin,
             irinotecan, and 5-FU with or without leucovorin for treatment of advanced or
             metastatic disease, unless the patient refused such treatment. Up to two prior
             chemotherapeutic regimens are permitted.

          3. Patients must have measurable disease including liver metastases >/= 2.0 cm amenable
             to percutaneous CT or U/S guided biopsy and must agree to undergo two liver biopsies.

          4. Minimum of three weeks since any major surgery, radiation, or systemic anticancer
             therapy.

          5. Any clinically significant residual adverse events from any prior anticancer therapy
             must have resolved to grade /=18 years. Because no dosing or adverse event data are currently available on
             the use of gene therapy in patients < 18 years of age, children are excluded from this
             study.

          7. ECOG performance status 0 or 1.

          8. Adequate hematologic, hepatic and renal parameters: leukocytes >/= 3,000/microliter,
             absolute neutrophil count >/= 1,500/microliter, platelets >/= 100,000/microliter,
             hemoglobin >/= 9g/dL, total bilirubin /= 60 mL/min.

          9. PT/PTT are within normal limits.

         10. Women of childbearing potential must have a negative pregnancy test (serum or urine)
             within 14 days prior to treatment. Women must be surgically sterile or have been
             amenorrheic for at least 12 months to be considered of non-childbearing potential.

         11. Women of childbearing potential and men must agree to use double barrier contraception
             prior to study entry and continuing for 30 days after the last dose of study drug.

         12. Signed written informed consent/authorization form.

        Exclusion Criteria:

          1. Prior treatment with any investigational drug within the preceding 3 weeks of Cycle 1,
             Day 1.

          2. Uncontrolled brain or leptomeningeal metastases, including patients who continue to
             require glucocorticoids for brain or leptomeningeal metastases (Brain imaging studies
             are not required if the patient does not have a history of brain metastases and has no
             neurological signs or symptoms).

          3. Other malignancies within the past 3 years of Cycle 1, Day 1 except for adequately
             treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.

          4. Patients who have any known severe and/or uncontrolled medical conditions or other
             conditions that could affect their participation in the study.

          5. A known history of HIV seropositivity.

          6. Women who are pregnant or breast feeding.

          7. History of MI within 6 months of Cycle 1, Day 1, angina, history of arrhythmias on
             active therapy, patients with LV ejection fraction 					

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Milind Javle, MD, , 



Administrative Informations


NCT ID

NCT00968604

Organization ID

2007-0762

Secondary IDs

1 R21 CA135 60401A1

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Milind Javle, MD, Study Chair, M.D. Anderson Cancer Center


Verification Date

April 2019