RATIONALE: Biological therapies such as flt3L and CD40-ligand use different ways to
stimulate the immune system and stop cancer cells from growing. Biological therapy may be an
effective treatment for metastatic melanoma and metastatic kidney cancer.
PURPOSE: Phase I trial to study the effectiveness of flt3L combined with CD40-ligand in
treating patients who have metastatic melanoma or metastatic kidney cancer.
OBJECTIVES: I. Determine the maximum tolerated dose of CD40-ligand when combined with
fixed-dose flt3 ligand in patients with metastatic melanoma or renal cell cancer.
OUTLINE: This is a dose-escalation study of CD40-ligand. Patients receive fixed-dose flt3
ligand subcutaneously (SC) daily on days 1-14 and CD40-ligand SC daily on days 12-16.
Treatment continues every 28 days for a maximum of 6 courses in the absence of unacceptable
toxicity or disease progression. Cohorts of 3 to 6 patients receive escalating doses of
CD40-ligand until the maximum tolerated dose (MTD) is determined. The MTD is defined as the
dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients
with progressive disease after 2 courses may be eligible to receive high-dose interleukin-2
(IL-2) standard therapy.
PROJECTED ACCRUAL: A total of 5 patients were accrued for this study.
DISEASE CHARACTERISTICS: Histologically confirmed metastatic renal cell cancer or melanoma
PATIENT CHARACTERISTICS: Age: 16 and over Performance status: ECOG 0-1 Life expectancy:
More than 3 months Hematopoietic: WBC at least 3,000/mm3 Platelet count at least
90,000/mm3 No coagulation disorders Hepatic: Bilirubin no greater than 1.6 mg/dL AST and
ALT less than 2.5 times normal Hepatitis B surface antigen negative Renal: Creatinine no
greater than 2.0 mg/dL Cardiovascular: No major active medical illness of the
cardiovascular system (e.g., cardiac ischemia, myocardial infarction, or cardiac
arrhythmia) Pulmonary: No major active medical illness of the respiratory system (e.g.,
obstructive or restrictive pulmonary disease) Other: Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception No active systemic
infections No history of autoimmune disorders HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy
No prior systemic flt3 ligand or CD40-ligand Chemotherapy: At least 3 weeks since prior
chemotherapy Endocrine therapy: At least 3 weeks since prior endocrine therapy No
concurrent systemic steroids Radiotherapy: Prior localized radiotherapy for renal cell
cancer or melanoma allowed Surgery: Prior surgery for renal cell cancer or melanoma