Clinical trial NCT00506142: Safety and Efficacy of Marqibo in Metastatic Malignant Uveal Melanoma
Official title: A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Malignant Uveal Melanoma
Lead sponsor: Spectrum Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2007-07-25
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patients were enrolled into the study in two cohorts. After completion of enrollment in Cohort 1, enrollment in Cohort 2 has commenced.
Primary purpose: TREATMENT

Brief summary: Marqibo (liposomal vincristine) is a form of vincristine preparation. Vincristine is designed to interfere with the multiplication of cancer cells, which may slow or stop their growing and spreading throughout the body. This may cause the cancer cells to die. Liposomal vincristine is formed when vincristine is placed inside of oil droplets called liposomes, which may help to improve the delivery of drug to the tumor site. The liposomal formulation results in a slow, steady release of vincristine in the tumor metastasis, exposing the cancer cells to vincristine continuously.

The goal of this clinical research study is to learn if Marqibo (liposomal vincristine) can help to control metastatic uveal melanoma. The safety of liposomal vincristine will also be studied.

Approximately 50 patients will take part in this study.


Eligibility criteria: Inclusion Criteria:

* Uveal melanoma with histologic or cytologic confirmation of metastatic disease.
* One unidimensionally measurable lesion. If this is a cutaneous lesion it must be at least 10 mm by caliper measure. If it is a visceral or nodal or soft tissue lesion, it must be \>20 mm with conventional techniques or \>10 mm with spiral CT scan. Bone lesions are not considered measurable.
* Must not have received any prior systemic chemotherapy, immunotherapy, vaccine or hepatic arterial chemotherapy for metastatic disease.
* Adequate liver, renal, and bone marrow function.
* Zubrod performance status of 0-2.
* Sign an informed consent form.

Exclusion Criteria:

* Major surgery within 4 weeks of enrollment.
* Advanced symptomatic central nervous system (CNS) involvement by melanoma and those on phenytoin or requiring steroids for brain metastases, spinal cord compression, or meningeal "carcinomatosis".
* History of neurological disorders unrelated to chemotherapy (including familial neurological diseases and acquired demyelinating disorders).
* Grade 2 or greater sensory, motor and/or autonomic neuropathy at screening from any cause.
* Receiving treatment with drugs known to inhibit or induce hepatic drug metabolism by cytochrome P450-3A4 isoenzymes and/or P-glycoprotein within 1 week of study enrollment.

Primary outcomes:
measure: Disease Control Rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Denver
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Houston
country: United States
facility: University of Texas M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: MD Anderson
name: Deborah Sanders, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bedikian AY, Silverman JA, Papadopoulos NE, Kim KB, Hagey AE, Vardeleon A, Hwu WJ, Homsi J, Davies M, Hwu P. Pharmacokinetics and safety of Marqibo (vincristine sulfate liposomes injection) in cancer patients with impaired liver function. J Clin Pharmacol. 2011 Aug;51(8):1205-12. doi: 10.1177/0091270010381499. Epub 2010 Oct 26.