C-VISA BikDD: Liposome in Advanced Pancreatic Cancer

NCT00968604 | Withdrawn Phase 1

• 3 other identifiers: 2007-07621 R21 CA135 60401A1NCI-2011-00466
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Pancreas; Liver; Liver Tumor Biopsy; BikDD Nanoparticle; C-VISA BikDD

Outcome Measures

Primary Outcomes (2)

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

  The maximum tolerated dose (MTD) is defined as the maximal achievable dose level at which \< 1/6 enrolled patients experiences dose-limiting toxicity.

  Weekly during 28 day cycles

• Dose-Limiting Toxicity (DLT)

  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.

  Continuously during 28 day cycles

Study Arms (1)

BikDD Nanoparticle

EXPERIMENTAL

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

Genetic: BikDD Nanoparticle

Interventions

BikDD Nanoparticle GENETIC

Starting dose 0.04 mg/kg once weekly by vein over 10 minutes.

Also known as: Bik gene product, Cholesterol liposome-based nanoparticle

BikDD Nanoparticle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically or cytologically confirmed advanced pancreatic adenocarcinoma that is unresectable or metastatic.
• 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.
• 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.
• Minimum of three weeks since any major surgery, radiation, or systemic anticancer therapy.
• 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.
• 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.
• ECOG performance status 0 or 1.
• 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.
• PT/PTT are within normal limits.
• 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.
• 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.
• Signed written informed consent/authorization form.

You may not qualify if:

• Prior treatment with any investigational drug within the preceding 3 weeks of Cycle 1, Day 1.
• 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).
• 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.
• Patients who have any known severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study.
• A known history of HIV seropositivity.
• Women who are pregnant or breast feeding.
• History of MI within 6 months of Cycle 1, Day 1, angina, history of arrhythmias on active therapy, patients with LV ejection fraction \</= 50%.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Milind Javle, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2009
• First Posted: August 31, 2009
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: April 11, 2019

Record last verified: 2019-04