MDACC Study Summary 2006-0910

Study Summary
No. 2006-0910:.......Melanoma......Agop Y. Bedikian......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2006-0910

Study Title:	A Phase II Study of MARQIBO in Patients with Metastatic Uveal Melanoma

Physician

New Patient Referral



Name:	Agop Y. Bedikian	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Melanoma Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2921 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	Every 2 weeks

Treatment Agents:	Marqibo	Home Care:	No

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	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.

Study Objectives / Outcomes

The primary objective of this study is to evaluate:
• The efficacy of Marqibo as determined by Disease Control Rate (CR, PR or durable
SD) in patients with metastatic malignant uveal melanoma

The secondary objectives of this study are to evaluate:

• response rate (CR+PR)

• progression free survival

• overall survival

• safety

•cardiac safety (cardiac Holter monitoring, including pharmacokinetics

Study Status Information



Study Activation / Registration Date:	09/07/2007

IRB Review and Approval Date:	03/23/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Open

Projected Accrual:	30

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients must meet all of the following inclusion criteria to be eligible for participation in this study: Patients must be >/=18 years old.

2) Patients must have uveal melanoma and histologic/cytologic confirmation of metastatic disease when possible.

3) Patients must have at least 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.

4) Cohort 1: Patients may be previously untreated or may have received one prior systemic chemotherapy. Prior treatment with immunotherapy or vaccine is allowed provided there is documentation of disease progression. Prior treatment with hepatic arterial chemotherapy infusion/perfusion or chemoembolization of liver metastasis is allowed as long as there is extrahepatic disease or progression of the liver metastasis after regional therapy. Patient must not have been previously treated with regimens containing vinca alkaloids.

5) (Continued 4) Cohort 2: Patients must not have received any prior systemic chemotherapy, immunotherapy, vaccine or hepatic arterial chemotherapy for metastatic disease.

6) Patients must have adequate liver and renal function as defined by total bilirubin no greater than the institution's upper normal limit. Patients must have adequate renal function demonstrated by a creatinine level of 2.0 mg/dL or less.

7) Patients must have adequate bone marrow function as defined by an absolute neutrophil count >/=1,000/mm^3, and platelet count >/= 100,000/mm^3.

8) Lesions being used to assess disease status may not have been radiated or if so, must have progressed during or after radiation therapy.

9) Patients must have ECOG (Zubrod) performance status of 0 - 2.

10) Cohort 1: Patients must have recovered from the adverse effects of prior chemotherapy (including cytotoxic agents and biological response modifiers), and/or irradiation therapy. Cohort 2: Patients must not have received prior chemotherapy (including cytotoxic agents and biological response modifiers) for metastatic disease.

11) Patients must sign an informed consent form indicating that they are aware of the investigational nature of this study and in keeping with the policies of the institution.

12) Cohort 1: At least 6 weeks (42 days) since any prior immunotherapy, cytokine, biologic, vaccine or other therapy unless patients have progressed during therapy. If progression occurred during therapy, patient must have recovered from any side effects before starting Marqibo. Cohort 2: Patients must not have received prior immunotherapy, cytokine, biologic, vaccine or other therapy for treatment of metastatic disease.

13) Patients must never have received prior Marqibo treatment.

Exclusion Criteria:

1) Patients who meet any of the following exclusion criteria are not to be enrolled in this study: Cohort 1: Patients treated with radiotherapy, chemotherapy, immunotherapy, vaccine treatment and/or alternative anticancer treatments (including investigational drugs) within 3 weeks prior to study enrollment. Cohort 2: Patients treated with chemotherapy, immunotherapy, vaccine treatment and/or alternative anti-cancer treatments for metastatic disease.

2) Cohort 1: Patients treated with hepatic chemoembolization within 4 weeks prior to study enrollment. Cohort 2: Patients treated with hepatic chemoembolization.

3) Patients with serious intercurrent illness.

4) Patients who have had major surgery within 4 weeks of enrollment.

5) Patients with 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". Patients with asymptomatic metastatic CNS disease that has remained stable for at least 6 weeks can be enrolled.

6) Patients receiving treatment with phenytoin and/or corticosteroids within 1 week of enrollment. Patients must remain off of these medications for the duration of the treatment phase of the study. Intrathecal chemotherapy for CNS prophylaxis is allowable.

7) Patients with a history of neurological disorders unrelated to chemotherapy (including familial neurological diseases and acquired demyelinating disorders).

8) Patients with Grade 2 or greater, sensory, motor and/or autonomic neuropathy at screening for any cause.

9) Patients receiving treatment with drugs known to inhibit or induce hepatic drug metabolism by cytochrome P450-3A isoenzymes and/or P-glycoprotein within 1 week of study enrollment.

10) Patients who are pregnant or lactating. Females of childbearing potential must have a negative urine or blood pregnancy test at screening. Both men and women must be practicing an acceptable method of birth control for duration of study. Acceptable methods of birth control include use of intrauterine device (IUD), oral contraceptive pills, implanted, transdermal, or injected contraceptives, barrier methods with spermicide, and abstinence.

11) Patients who are unable to return for follow up re-evaluation and assessment of response to Marqibo.

12) Patients with isolated small (<2 cm) liver nodule are not eligible.

13) History of persistent >/=Grade 2 active neurologic disorders unrelated to chemotherapy (including demyelinating form of Charcot-Marie-Tooth syndrome, acquired demyelinating disorders, or other demyelinating condition).

14) Known positive human immunodeficiency virus (HIV) status.

15) Active serious infection not controlled by oral or intravenous antibiotics or antifungals.

16) Patients with the following conditions (Cohort 2 only): a. Long QT syndrome, b. Recurrent syncope, c. TdP, d. Aborted sudden death, e. Heart failure, f. Myocardial ischemia, g. Hypokalemia, h. Hypomagnesemia, i. Complete right bundle branch block, j. Complete/incomplete left bundle branch block, k. Intraventricular conduction defects l. QT interval >/=460 msec.

Links

Registration Number: NCT00506142
Study Information on Clinical Trials Registry (clinicaltrials.gov)