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TREATMENT OF METASTATIC MELANOMA WITH RECOMBINANT INTERLEUKIN-2


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Melanoma (Skin)

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Trial Information

TREATMENT OF METASTATIC MELANOMA WITH RECOMBINANT INTERLEUKIN-2


OBJECTIVES: I. Evaluate the response and survival rates of patients with metastatic melanoma
following induction with high-dose and maintenance with low-dose interleukin-2. II. Assess
the toxicity of this regimen.

OUTLINE: All patients receive high-dose interleukin-2 over 24 hours, followed by low-dose
interleukin-2 for 4 days in the absence of toxicity. Patients receive a second cycle
beginning 9-13 days after completion of the first cycle, with response assessed
approximately 2 months after initiating therapy. Patients with stable or responding disease
receive a second course as above; those with a continued response may receive additional
courses provided toxicity is limited. Patients are followed for survival.

PROJECTED ACCRUAL: 20 patients will be entered.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven melanoma that is metastatic No tumor
replacement of 25% or more of liver on CT or MRI No involvement of the CNS or a major
nerve Measurable disease required

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80%-100% Life
expectancy: More than 3 months Hematopoietic: No coagulopathy (i.e., platelets less than
80,000) Hepatic: Bilirubin normal Renal: Creatinine normal Cardiovascular: No abnormal
cardiac stress test in patients over 50 years of age or with possible cardiac disease
suggested by history, physical exam, or EKG Pulmonary: FEV1 or VC greater than 65% of
predicted in patients with significant smoking history or with suspected pulmonary disease
by history, physical exam, or x-ray Other: No site of ongoing bleeding No systemic
infection No HIV antibody No HBsAg No requirement for steroids No psychiatric disease that
precludes informed consent or protocol treatment No second malignancy except: Basal cell
skin carcinoma Carcinoma in situ of the cervix No pregnant or nursing women Negative
pregnancy test required of fertile women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: No prior interleukin-2 At least 28 days since treatment for
melanoma

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Richard L. White, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Blumenthal Cancer Center at Carolinas Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000065084

NCT ID:

NCT00002845

Start Date:

September 1995

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • recurrent melanoma
  • Melanoma

Name

Location
Carolinas Medical Center Charlotte, North Carolina  28232-2861