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| Sponsored by: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066521 |
Purpose
RATIONALE: Drugs used in chemotherapy such as melphalan and temozolomide use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of isolated hepatic (liver) perfusion with melphalan followed by temozolomide in treating patients who have unresectable liver metastases that has resulted from ocular (eye) melanoma.
| Condition | Intervention | Phase |
|
Intraocular Melanoma Metastatic Cancer |
Drug: melphalan Drug: temozolomide Procedure: adjuvant therapy Procedure: isolated perfusion |
Phase II |
| Genetics Home Reference related topics: | retinoblastoma |
| MedlinePlus related topics: | Cancer Melanoma |
| ChemIDplus related topics: | Melphalan Temozolomide Melphalan hydrochloride Sarcolysin |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 |
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2003 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients who are otherwise eligible undergo exploration through a limited incision. Patients with peritoneal seeding or unresectable extrahepatic metastatic disease are removed from study. All other patients undergo isolated hepatic perfusion (IHP) and receive melphalan intra-arterially over 1 hour.
Within 8-12 weeks after IHP, patients are re-evaluated by MRI. Patients with stable or responding disease receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, 8-12 weeks after IHP, every 3 months during temozolomide, and at all follow-up visits.
Patients are followed every 3 months for 2 years and then every 4 months thereafter.
PROJECTED ACCRUAL: A total of 9-40 patients will be accrued for this study
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed ocular melanoma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |||||
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |||||
| Bethesda, Maryland, United States, 20892-1182 | |||||
| Study Chair: | Steven K. Libutti, MD | NCI - Surgery Branch |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Featured trial article 
  |
| Study ID Numbers: | CDR0000316262, NCI-03-C-0221 |
| First Received: | August 6, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00066521 |
| Health Authority: | United States: Federal Government |
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