Trials / Completed
CompletedNCT00003022
Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Brain and Central Nervous System Tumors
- Intraocular Melanoma
- Lung Cancer
- Melanoma (Skin)
- Neuroblastoma
- Retinoblastoma
- Sarcoma
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | iodine I 131 monoclonal antibody 3F8 |
Timeline
- Start date
- 1997-04-01
- Primary completion
- 2005-01-01
- Completion
- 2005-01-01
- First posted
- 2003-01-27
- Last updated
- 2013-07-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00003022. Inclusion in this directory is not an endorsement.