Patient case: 49-year-old male with melanoma; genetic feature: extensive tumor infiltrating lymphocytes

Clinical trial: Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

Summary: RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
  PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have leptomeningeal metastases.

Detailed description: OBJECTIVES:
  -  Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 (I-3F8) in patients with GD2 positive leptomeningeal neoplasms.
  -  Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors.
  -  Measure the cerebrospinal fluid (CSF) levels and serum pharmacokinetics of I-3F8 in these patients.
  OUTLINE: This is a dose escalation study.
  Patients receive a single injection of intraventricular or intrathecal iodine I 131 monoclonal antibody 3F8. Patients without objective disease progression and no grade 3 or 4 toxicity 6 weeks after the first dose may receive a second injection.
  Cohorts of at least 3 patients are entered at escalating doses of I-3F8. If grade 3 or worse toxicity occurs in 1 or more of 3 patients at a given dose level, then 3 additional patients are accrued at that level. If 2 or more of 6 patients at a given dose level experience grade 3 or worse toxicity, then that dose is declared the maximum tolerated dose (MTD).
  Patients are followed weekly for 4 weeks.
  PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study over 2-3 years.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed malignancy expressing GD2, including, but not limited to:
  -  Medulloblastoma/primitive neuroectodermal tumor of the CNS
  -  Malignant glioma
  -  Neuroblastoma
  -  Retinoblastoma
  -  Ependymoma
  -  Sarcoma
  -  Melanoma
  -  Small cell lung carcinoma
  -  Other tumor types must have GD2 expression confirmed by immunohistochemical staining
  -  Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional therapy or for which no conventional therapy exists
  -  Prior measurable human anti-mouse monoclonal antibody titer allowed
  PATIENT CHARACTERISTICS:
  Age:
  -  3 and over
  Performance status:
  -  Not specified
  Life expectancy:
  -  At least 2 months
  Hematopoietic:
  -  Absolute neutrophil count greater than 1,000/mm^3
  -  Platelet count greater than 50,000/mm^3
  Hepatic:
  -  Bilirubin less than 3 mg/dL
  Renal:
  -  Creatinine less than 2 mg/dL
  -  Blood urea nitrogen less than 30 mg/dL
  Other:
  -  May have active malignancy outside the central nervous system
  -  No obstructive hydrocephalus
  -  No CNS grade 3 or 4 toxicity as a consequence of prior treatments
  -  No life threatening infection
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Prior monoclonal antibody treatment allowed
  Chemotherapy:
  -  Prior chemotherapy allowed
  -  Must have recovered from all hematopoietic and neurologic side effects of prior chemotherapy
  Endocrine therapy:
  -  Not specified
  Radiotherapy:
  -  Prior radiotherapy allowed
  -  At least 6 weeks since prior cranial or spinal irradiation
  Surgery:
  -  Not specified

Relevance to patient case: not relevant