Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

Overview

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.

Full Title of Study: “Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
  • Study Primary Completion Date: January 2005

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.

Interventions

  • Radiation: iodine I 131 monoclonal antibody 3F8

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Memorial Sloan Kettering Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Overall Official(s)
    • Kim Kramer, MD, Study Chair, Memorial Sloan Kettering Cancer Center

Citations Reporting on Results

Kramer K, Humm JL, Souweidane MM, Zanzonico PB, Dunkel IJ, Gerald WL, Khakoo Y, Yeh SD, Yeung HW, Finn RD, Wolden SL, Larson SM, Cheung NK. Phase I study of targeted radioimmunotherapy for leptomeningeal cancers using intra-Ommaya 131-I-3F8. J Clin Oncol. 2007 Dec 1;25(34):5465-70. doi: 10.1200/JCO.2007.11.1807.

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