A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma
16 Years
N/A
Both
Melanoma (Skin)
Trial Information
A Prospective Random Assignment Trial Comparing Complete Metastasectomy to Chemotherapy for Selected Patients With Stage IV Melanoma
OBJECTIVES:
Primary
- Compare overall survival in patients with stage IV melanoma treated with complete
metastasectomy vs dacarbazine and/or cisplatin.
Secondary
- Compare time to progression in patients treated with these regimens.
- Determine the response rate in patients treated with dacarbazine and/or cisplatin.
- Compare the morbidity and quality of life of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to prior exposure to
dacarbazine and cisplatin (yes vs no) and number of sites of metastases (1 vs 2 or more).
Patients are randomized to 1 of 2 treatment arms.
- Arm I (surgery): Patients undergo complete metastasectomy. Patients with disease
progression after surgery may undergo repeat resection or may receive dacarbazine
and/or cisplatin as in arm II.
- Arm II (systemic therapy): Patients receive dacarbazine IV over 30-60 minutes and/or
cisplatin IV over 30 minutes on days 1, 2, 3, 22, 23, and 24 (1 course). Courses repeat
every 42 days in the absence of disease progression or unacceptable toxicity. Patients
achieving a complete response (CR) receive at least 1 additional course of chemotherapy
beyond CR and are eligible for other investigational strategies.
Quality of life is assessed at baseline, at 3 and 6 months, and at 1 year.
Patients are followed every 3-4 months for 2 years, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 74 patients (37 per treatment arm) will be accrued for this
study within 4 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of metastatic melanoma
- Solitary pulmonary nodule may not be sole site of metastatic disease
- No disease limited to subcutaneous, cutaneous, or peripheral nodal (neck,
axillary, groin, or iliac nodes) sites only
- Measurable disease
- Disease progression during or after prior interleukin-2 (IL-2)-based therapy OR
ineligible for high-dose IL-2 therapy
- Metastatic disease amenable to complete surgical resection
- Less than 5% estimated mortality from surgery
- Prior complete metastasectomy allowed provided disease did not recur within 6
months after surgery
- No primary ocular or mucosal melanoma
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 16 and over
Performance status
- ECOG 0-2
Life expectancy
- More than 3 months
Hematopoietic
- WBC at least 3,000/mm^3 OR
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- No coagulation disorder
Hepatic
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal
- Creatinine no greater than 1.6 mg/dL OR
- Creatinine clearance at least 70 mL/min
- No major medical illness of the renal system
Cardiovascular
- No major medical illness of the cardiovascular system
Pulmonary
- No major medical illness of the respiratory system
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- HIV negative
- No active systemic infection
- No form of primary or secondary immunodeficiency
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No concurrent palliative radiotherapy
Surgery
- See Disease Characteristics
- No concurrent palliative surgery
Other
- More than 3 weeks since prior therapy for melanoma (except surgery)
- No other concurrent therapy for melanoma
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
Richard M. Sherry, MD
Investigator Role:
Study Chair
Investigator Affiliation:
NCI - Surgery Branch
Authority:
United States: Federal Government
Study ID:
CDR0000335471
NCT ID:
NCT00072124
Start Date:
September 2003
Completion Date:
May 2005
Related Keywords:
- Melanoma (Skin)
- stage IV melanoma
- recurrent melanoma
- Melanoma
Name | Location |
|---|---|
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda, Maryland 20892-1182 |
