Clinical trial NCT00559117: A Phase I Study to Assess the Safety and Distribution of VB-111 in Patients With Advanced Metastatic Cancer
Official title: A Phase I, Open-Label, Dose Ranging Study to Assess the Safety and Distribution of Single or Multiple Doses of VB-111 in Patients With Advanced Metastatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced and/or Metastatic Solid Organ Cancer
Lead sponsor: Vascular Biogenics Ltd. operating as VBL Therapeutics
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in Patients with Advanced Metastatic Cancer

Detailed description: Nine Cohorts of dose escalating VB-111 were completed with a total of 56 subjects enrolled.

Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years of age
* Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. For Cohort 8, malignancy will include only NET or RCC.
* Karnofsky performance status of ≥70%
* Patients with an adequate hematological profile
* Patients with an adequate renal function
* Males and Females of childbearing potential must utilize a standard contraception method
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Pregnant or breastfeeding patients
* Patients, who suffered from an acute cardiac event within the last 12 months
* Patients with active vascular disease, either myocardial or peripheral
* Patients with proliferative and/or vascular retinopathy
* Patients with known liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune)
* Patients with known CNS metastatic disease
* Patients testing positive to one of the following viruses: HIV, HBV or HCV
* Patients receiving chemotherapy or radiotherapy within the last 4 weeks before enrolment
* Patients that have undergone major surgery within the last 4 weeks before enrolment
* Patients may not have received anti-angiogenic therapy within the previous 8 weeks before enrolment.
* Patients may not have received any other investigational agent within 4 weeks before enrolment.
* Patients with an ongoing requirement for an immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before enrolment
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Primary outcomes:
measure: Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber/Brigham and Women's Cancer Center
state: Massachusetts
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: San Antonio
country: United States
facility: UTHSC- CTRC and Institute for Drug Development
state: Texas
Study officials:
affiliation: The Cleveland Clinic
name: Pierre Triozzi, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: UTHSC- CTRC and Institute for Drug Development
name: Andrew Brenner, MD
role: PRINCIPAL_INVESTIGATOR
References: