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Clinical Trials/NCT00003022
NCT00003022CompletedPhase 1

Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms

Memorial Sloan Kettering Cancer Center1 site in 1 countryStarted: April 1997Last updated:
Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Locations
1

Study Overview

Brief 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).

Study Design

Study Type
Interventional
Primary Purpose
Treatment

Eligibility Criteria

Ages
3 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Investigators

Study Sites (1)

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