MDACC Study Summary 2006-0603

Study Summary
No. 2006-0603:.......Melanoma......Agop Y. Bedikian......Melanoma Medical Oncology

Study Summary Title



Study Summary Number:	2006-0603

Study Title:	PHASE I STUDY OF HEPATIC ARTERIAL INFUSION OF NAB-PACLITAXEL (ABRAXANEŽ) IN PATIENTS WITH METASTATIC MELANOMA IN THE LIVER

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:	Abraxis Bioscience Abraxis Bioscience

Phase of Study:	Phase I	Return Visit:	Every 3 weeks

Treatment Agents:	Abraxane	Home Care:	No

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	2 days every 3 weeks.


Description/ Intervention:	The goal of this clinical research is to find the highest tolerable dose of Abraxane (nab-paclitaxel) when given directly to the area where the cancer is located. The safety of this drug will also be studied.

Study Objectives / Outcomes

Primary Objectives (Phase I):
1.1 To determine the maximally tolerated dose and Phase II dose of nab-paclitaxel administered through hepatic artery for therapy of metastatic melanoma mostly confined to the liver.
1.2 To determine the safety of nab-paclitaxel administered through hepatic artery for therapy of melanoma metastatic to the liver.

Primary Objective (Phase I Extension):
1.3 To determine the response rate of metastatic melanoma to the liver when treated with nab-paclitaxel administered via hepatic artery one day every 3 weeks

Secondary Objective(Phase I Extension):
1.4 To determine the duration of response in the liver and survival (overall survival or progression free survival)of patients treated with intraarterial intrahepatic administration of nab-paclitaxel one day every 3 weeks for melanoma metastatic to the liver.
1.5 To determine the safety of nab-paclitaxel administered through hepatic artery for therapy of melanoma metastatic to the liver.

Study Status Information



Study Activation / Registration Date:

IRB Review and Approval Date:	12/04/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Closed

Projected Accrual:	N/A

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 have histologic confirmation of malignant melanoma, and documented metastatic disease.

2) Patients must have at least one clearly measurable metastatic lesion in the liver that is more than 2cm in the largest dimension. Indicator lesions at least 2cm are chosen primarily to have changes in tumor measurement more accurately reflective of effect of therapy, or lack of it.

3) Patients must not have received prior systemic chemotherapy with regimens including taxanes. Prior adjuvant treatment with immunotherapy or vaccine therapy is allowed provided there is documentation of disease progression in the liver.

4) At least 4 weeks (28 days) since any prior immunotherapy, cytokine, biologic, vaccine therapy or tumor embolization in the liver and patients should have progressed during therapy. Patient must have recovered from any side effects before starting therapy on this protocol.

5) At least 4 weeks (28 days) since prior radiotherapy (if radiation therapy field covering > 20% of the bone marrow containing skeletal structures) and prior adjuvant therapy. Patient must have recovered from any side effects before starting therapy on this protocol.

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

7) Patients must have ECOG performance status of 0 - 2.

8) Patients must be >/= 18 years of age. The safety of NAB-Paclitaxel has not been studied in younger patients.

9) Patients must have normal serum total bilirubin level, transaminase levels (i.e., ALT and AST) no higher than 2.5 times the institution's upper normal limits. Patients must have adequate renal function: creatinine </= 1.5 mg/dL Patients must have adequate bone marrow function as defined by an absolute neutrophil count >/= 1,500/mm^3, platelet count >/= 100,000/mm^3 and hemoglobin >/= 9.0g/dL.

10) Life expectancy of at least 3 months.

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.

Exclusion Criteria:

1) Patients who have received prior systemic chemotherapy with regimens including taxanes.

2) Patients with history of CNS metastasis prior to registering to this study.

3) Patients who are pregnant or nursing and patients who are not practicing an acceptable method of birth control. A negative pregnancy test (urine or serum) must be documented at baseline for women of childbearing potential. Patients may not breast-feed while on this study.

4) Patients with current active infections requiring anti-infectious treatment (e.g., antibiotics, antivirals, or antifungals).

5) Patients with current peripheral neuropathy of any etiology that is greater than grade one.

6) Patients with unstable or serious concurrent medical conditions are excluded. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.

7) Patients must not have had major surgery including node dissection, resection of melanoma metastatic to an organ or other surgical procedures that require hospitalization and administration of general anesthesia within the past 14 days.

8) Patients must not receive any concurrent chemotherapy, radiotherapy, or immunotherapy while on study.

9) Known HIV disease or infection.

10) Patients with ascites are not eligible

Links

Registration Number: NCT00833807
Study Information on Clinical Trials Registry (clinicaltrials.gov)