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C-VISA BikDD: Liposome in Advanced Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00968604
Recruitment Status : Withdrawn (Stability of the DNA when admixed with the liposome failed)
First Posted : August 31, 2009
Last Update Posted : January 19, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Genetic: BikDD Nanoparticle Phase 1

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: BikDD Nanoparticle
BikDD Nanoparticle starting dose 0.04 mg/kg once weekly by vein over 10 minutes.
Genetic: BikDD Nanoparticle
Starting dose 0.04 mg/kg once weekly by vein over 10 minutes.
Other Names:
  • Bik gene product
  • Cholesterol liposome-based nanoparticle


Outcome Measures

Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) of BikDD Nanoparticle in Patients with Advanced Pancreatic Cancer [ Time Frame: Weekly during 28 day cycles ]
    The maximum tolerated dose (MTD) is defined as the maximal achievable dose level at which < 1/6 enrolled patients experiences dose-limiting toxicity.

  2. Dose-Limiting Toxicity (DLT) [ Time Frame: Continuously during 28 day cycles ]

    Dose-limiting toxicity (DLT) defined as:

    Any ≥ grade 3 hematologic and non-hematologic toxicity as per NCI CTCAE v. 4.0 with the following exceptions:

    1. Grade 3 or 4 lymphopenia unless persistent for >14 days or associated with single oral temperature of >38.3°C (101°F) or temp > 38°C (100.4°F) measured on two separate occasions one hour apart.
    2. Adverse events (Grade 3 or greater) for which a clinical cause unrelated to study drug is evident will not be considered DLTs. These will include: obstructive jaundice from stent occlusion, narcotic-induced constipation if symptom is present prior to study enrollment, anorexia or cachexia if present prior to study enrollment.
    3. Delay of Dose > 14 days due to toxicity.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 </= 1 or baseline as per the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
  6. Age >/=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 </= 1.5 mg/dL, AST and ALT </= 3 x upper limit of normal (ULN) for subjects with documented liver metastases; AST and ALT </= 2.5 x ULN for subjects without evidence of liver metastases, creatinine </= 1.5 mg/dL and calculated creatinine clearance of >/= 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 </= 50%.
Contacts and Locations

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): NCT00968604


Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Milind Javle, MD M.D. Anderson Cancer Center
More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00968604     History of Changes
Other Study ID Numbers: 2007-0762
1 R21 CA135 60401A1 ( Other Grant/Funding Number: NCI )
NCI-2011-00466 ( Registry Identifier: NCI CTRP )
First Posted: August 31, 2009    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Keywords provided by M.D. Anderson Cancer Center:
Pancreatic Cancer
Pancreas
Liver
Liver Tumor Biopsy
BikDD Nanoparticle
C-VISA BikDD

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases