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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Advanced and/or Metastatic Solid Organ Cancer

Thank you

Trial Information

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


Seven Cohorts of dose escalating VB-111 were completed with a total of 33 subjects enrolled.

An additional cohort (Cohort 8) has been added to include multiple doses of VB-111 within
disease specific subgroups (Neuroendocrine Tumor, Renal Cell Carcinoma). Subjects will
receive a single infusion of VB-111 every 2 months until progression. 18-36 subjects are
expected to be enrolled at 3 centers.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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)

Outcome Time Frame:

2 months

Safety Issue:

No

Principal Investigator

Pierre Triozzi, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Cleveland Clinic

Authority:

United States: Food and Drug Administration

Study ID:

GT-111001 (VB-111)

NCT ID:

NCT00559117

Start Date:

November 2007

Completion Date:

Related Keywords:

  • Advanced and/or Metastatic Solid Organ Cancer
  • Neoplasm Metastasis

Name

Location

Cleveland ClinicCleveland, Ohio  44195
Dana Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02215
UTHSC- CTRC and Institute for Drug DevelopmentSan Antonio, Texas  78229