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


Phase 3
16 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

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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 SupportBethesda, Maryland  20892-1182