A Phase II Study of Isolated Hepatic Perfusion (IHP) in Patients With Ocular Melanoma

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00062933
First received: June 17, 2003
Last updated: August 17, 2012
Last verified: August 2012
  Purpose

Ocular melanoma, or cancer of the eye, is a rare form of cancer that can spread to the liver. A tumor in the liver, because of its size or location, sometimes cannot be removed with surgery.

The purpose of this study is to determine whether chemotherapy delivered only to the liver, called isolated hepatic perfusion (IHP), followed by systemic (to the whole body) chemotherapy improves the ability to treat cancer.

Study participants must be 18 years or older and have ocular melanoma that has spread to the liver. Before enrolling in the study, they will undergo the following evaluations: a physical exam; x-rays; blood tests; electrocardiogram; computed tomography (CT) scan of the chest, abdomen and pelvis; and a magnetic resonance imaging (MRI) scan of the liver.

The study includes a 15-minute quality-of-life questionnaire. Participants will complete the questionnaire 7 times over a period of 2 years to help investigators gauge their health status and progress.

A laparotomy is done, which allows a surgeon to view the tumor in the liver through a small incision in the abdomen while the patient is under general anesthesia. Sometimes the tumor can spread outside the liver in a way that cannot be seen by pre-operative scans. When this happens, the participant is ineligible to continue in the study, since an important part of the treatment is given only to the liver.

If the laparotomy reveals that the participant is eligible for the remainder of the study, the participant will receive IHP treatment during the surgery. Plastic tubes called catheters are placed in the vein and artery that feed and drain the liver. This creates a separate blood supply for the liver alone. Heated chemotherapy is then given into the liver blood supply for one hour, while being carefully kept out of the rest of the body.

After recovering from the surgery, eligible participants will receive a systemic chemotherapy called temozolomide for up to one year. This chemotherapy is taken by mouth in capsule form.

Participants will be asked to return to NIH 10-11 times during the first year to evaluate their progress.


Condition Intervention Phase
Melanoma
Procedure: Laparotomy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Study of Isolated Hepatic Perfusion (IHP) With Melphalan Followed by Temozolomide for Subjects With Unresectable Hepatic Metastases From Ocular Melanoma

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 40
Study Start Date: June 2003
Study Completion Date: March 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Patients with unresectable hepatic metastases secondary to ocular melanoma will undergo a 60 minute hyperthermic isolated hepatic perfusion with 1.5mg/kg melphalan followed by up to one year of oral temozolomide. Response to treatment, duration of response, patterns of failure, survival, and quality of life end-points will be followed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Histologically or cytologically proven measurable metastatic ocular melanoma confined to the liver. Patients with limited sites of extra-hepatic disease and who have dominant life-limiting disease in liver will be considered eligible if the extra-hepatic sites can be treated with local ablative measures such as resection or external beam radiation therapy. Patients with limited extra-hepatic disease will undergo IHP and treatment of extra-hepatic disease in a sequence determined by the clinical presentation but all patients will have had all disease treated prior to initiating temozolomide therapy.

Patients must have had no chemotherapy, radiotherapy, or biologic therapy for their malignancy for 28 days prior to the liver perfusion and must have recovered from all side effects except those outlined in appendix III.

Patients must have an ECOG performance standard of 0,1 or 2 prior to on-study and on the day prior to treatment with IHP.

Patients must have adequate hepatic function as evidenced by bilirubin less than 2.0 mg/dL and a PT equal to 2 seconds of the upper normal limit AST/ALT less than or equal to 10 times ULN.

Patients must be 18 years of age or greater and must be greater than 30 kg, because of reason outlined in Section 6.2.

Patients must have a platelet count greater than 75,000, a HCT greater than 27.0, an ANC greater than or equal to 1,500/ul, and a creatinine less than or equal to 1.5 mg/dL unless the measured creatinine clearance is greater than 60 mL/min/1.73 m(2).

Patients must be aware of the neoplastic nature of his/her illness, the experimental nature of the therapy , alternative treatments, potential benefits, and risks. The patient must be willing to sign an informed consent.

EXCLUSION CRITERIA:

Pregnant patients and nursing mothers will be excluded due to the unknown effects of melphalan on the fetus or newborn.

Patients taking immunosuppressive drugs or on chronic anticoagulation will not be eligible.

Patients with active systemic infections are not eligible.

Patients with biopsy proven cirrhosis or evidence of significant portal hypertension by history, endoscopy, or radiologic studies will be excluded.

Patients with a history of congestive heart failure with an LVEF less than 40% will be excluded.

Patients with COPD or other chronic pulmonary disease with PFT's less than 50% predicted for age will be excluded.

Patients with a history or diagnosis of veno-occlusive disease (VOD) will be excluded.

Patients with chronic active hepatitis based on a positive serology test for surface antigen B or C will be excluded if there is evidence of cirrhosis on pathology. If no pathology specimen exists then evidence for cirrhosis will be determined based on radiological studies and physical examination. If there are no indications of it then the patient will be registered on study and a biopsy will be obtained at the time of laparotomy for IHP with the expectation that occult clinically significant cirrhosis is very unlikely. If cirrhosis is pathologically confirmed the patient will not undergo treastment and be taken off study. Patients with radiographic or other signs of cirrhosis will undergo percutaneous biopsy prior to registration.

Patients with a prior hypersensitivity reaction to melphalan, dacarbazine, or temozolomide will be ineligible for study.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062933

Locations
United States, Maryland
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00062933     History of Changes
Obsolete Identifiers: NCT00066521
Other Study ID Numbers: 030221, 03-C-0221
Study First Received: June 17, 2003
Last Updated: August 17, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Clinical Response
Duration of Response
Quality of Life
Hyperthermia
Survival
Melanoma
Ocular Melanoma
Eye Cancer

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on July 22, 2014