Metastatic Malignant Uveal Melanoma Clinical Trial
Official title:
A Phase 2 Study of Marqibo in Patients With Metastatic Uveal Melanoma
| Verified date | November 2019 |
| Source | Spectrum Pharmaceuticals, Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 54 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Colorado, Denver | Denver | Colorado |
| United States | University of Texas M.D. Anderson Cancer Center | Houston | Texas |
| United States | University of California, Los Angeles | Los Angeles | California |
| United States | Thomas Jefferson University | Philadelphia | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Spectrum Pharmaceuticals, Inc |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Disease Control Rate | Proportion of patients whose best overall response is complete response (CR), partial response (PR), or stable disease (SD) | 1 year |