Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Completed	3 and over	NCI	MSKCC-97021 NCI-G97-1267, NCT00003022

Objectives

1. Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 (I-3F8) in patients with GD2 positive leptomeningeal neoplasms.
2. Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors.
3. Measure the cerebrospinal fluid (CSF) levels and serum pharmacokinetics of I-3F8 in these patients.

Entry Criteria

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

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

Patient Characteristics:

Age:

• 3 and over

Performance status:

• Not specified

Life expectancy:

• At least 2 months

Hematopoietic:

• Absolute neutrophil count greater than 1,000/mm³
• Platelet count greater than 50,000/mm³

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

Expected Enrollment

Approximately 3-30 patients will be accrued for this study over 2-3 years.

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.

Kramer K, Humm JL, Souweidane MM, et al.: Phase I study of targeted radioimmunotherapy for leptomeningeal cancers using intra-Ommaya 131-I-3F8. J Clin Oncol 25 (34): 5465-70, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Kim Kramer, MD, Protocol chair		Ph: 212-639-6410; 800-525-2225 Email: kramerk@mskcc.org

Registry Information
Official Title		Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms
Trial Start Date		1997-04-08
Registered in ClinicalTrials.gov		NCT00003022
Date Submitted to PDQ		1997-04-08
Information Last Verified		2005-04-06
NCI Grant/Contract Number		P30-CA08748

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