Protocol Number: 03-C-0279

Title:

A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients with Stage IV Melanoma

Number:

03-C-0279

Summary:

This study will compare the effectiveness of surgery versus drug therapy in prolonging life and improving the quality of life of patients with stage IV melanoma. Currently, no treatment strategy can definitely improve the quality or length of life of patients with this advanced disease.

Patients 16 years of age and older with metastatic melanoma (melanoma that has spread from the original site to other parts of the body) whose disease has worsened while receiving interleukin-2 (IL-2) therapy, or who are ineligible to receive high-dose IL-2 therapy may participate in this study. Candidates must have disease that can be treated surgically. Patients with primary ocular or mucosal melanoma are excluded from this study. Candidates will be screened with a medical history and physical examination, CT or MRI of the chest, abdomen and pelvis, MRI of the brain, PET imaging, blood and urine tests, EKG, review of pathology slides, and pregnancy testing for women capable of bearing children. Participants will be randomly assigned to one of the following treatment groups:

Surgery

Patients in this group will have all known tumors removed surgically. After surgery, they will have x-rays every 3 to 6 months to check for new tumors. If the cancer recurs, repeat surgery will be considered, or chemotherapy with dacarbazine or cisplatin, or both, may be offered. Patients for whom these drugs are not appropriate will be advised of other research protocols that may be available.

Chemotherapy

Patients in this group will receive dacarbazine or cisplatin, or both, depending on their previous drug treatment. Chemotherapy will be given in 3-week cycles. Dacarbazine will be infused over 30 to 60 minutes through a catheter (plastic tube) placed in a vein. Infusions will be given on the first 3 days of each cycle. Cisplatin will also be given through a vein over 30 minutes on the first 3 days of each cycle. Patients receiving cisplatin will come to the Clinical Center the night before the infusions to receive intravenous fluids throughout the night, continuing until 3 hours after completing cisplatin in order to protect the kidneys from the effects of the chemotherapy. X-rays will be taken every 3 months to determine the response to treatment. Chemotherapy will continue until the tumors disappear or the side effects of the treatment become too severe. Patients whose tumors grow during treatment will be taken off the study and referred to another protocol if an appropriate one is available. Surgical removal of some or all of the tumors will be considered if they are causing significant problems.

Patients in either group who stop treatment may be asked to return to NIH for follow-up evaluations every 3 to 4 months for 2 years and then every 6 months until the end of 5 years.

Participants will also be asked to complete two quality of life questionnaires before beginning treatment and again at the 3-month, 6-month, and 12-month clinic visits. The questionnaires are designed to evaluate how people in this study feel, how well they are able to perform their usual activities, and how the treatment affects their general health and well-being.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

Any patient age greater than or equal to 16 with measurable metastatic melanoma who has progressed while receiving or after receiving treatment with IL-2 based therapy or who is ineligible to receive high dose IL-2 therapy and has an expected survival of greater than three months will be considered.

Patients must have metastatic disease, which is amenable to complete surgical resection and an estimated mortality from surgery of less than 5%.

Serum creatinine of 1.6 mg/dl or less or a creatinine clearance of at least 70 ml/min.

WBC 3000/mm(3) or greater, OR ANC greater than or equal to 1500/mm(3)

Platelet count 100,000 mm(3) or greater

ECOG performance status of less than or equal to 2

Patients of both genders must be willing to practice effective birth control during this trial.

EXCLUSION CRITERIA:

Patients will be excluded:

Who are undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their melanoma.

Patients who have developed new disease within six months of undergoing a previous complete metastasectomy will be excluded. Other patients who have undergone previous complete metastasectomy will be included.

Who have active systemic infections, coagulation disorders, or other major medical illnesses of the cardiovascular or respiratory systems, or renal systems which significantly increase a patient's operative risk.

Who are pregnant

Who are known to be positive for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody because of their potential for toxicity secondary to chemotherapy, or who have any form of primary or secondary immunodeficiency.

Who have brain metastasis.

Who have disease limited to subcutaneous, cutaneous, or peripheral nodal (neck, axillary, groin, iliac nodes) sites only.

Who have disease that requires palliative surgery or radiation

Who have a solitary pulmonary nodule as the sole site of metastatic disease.

Who have primary ocular or mucosal melanoma.

Special Instructions: Currently Not Provided

Keywords:

Patient Survival

Surgical Excision

Tumor Response

Morbidity

Time to Progression

Recruitment Keywords:

Melanoma

Conditions:

Melanoma

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Balch CM, Soong SJ, Gershenwald JE, Thompson JF, Reintgen DS, Cascinelli N, Urist M, McMasters KM, Ross MI, Kirkwood JM, Atkins MB, Thompson JA, Coit DG, Byrd D, Desmond R, Zhang Y, Liu PY, Lyman GH, Morabito A. Prognostic factors analysis of 17,600 melanoma patients: validation of the American Joint Committee on Cancer melanoma staging system. J Clin Oncol. 2001 Aug 15;19(16):3622-34. PMID: 11504744

Eton O, Legha SS, Bedikian AY, Lee JJ, Buzaid AC, Hodges C, Ring SE, Papadopoulos NE, Plager C, East MJ, Zhan F, Benjamin RS. Sequential biochemotherapy versus chemotherapy for metastatic melanoma: results

from a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2045-52. PMID: 11956264

Li Y, McClay EF. Systemic chemotherapy for the treatment of metastatic melanoma. Semin Oncol. 2002 Oct;29(5):413-26. Review. PMID: 12407507

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
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