Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003022
• Other study ID #: 97-021
• Secondary ID: CDR0000065607NCI
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: July 1, 2013
• Start date: April 1997
• Est. completion date: January 2005

Study information

• Verified date: July 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Intraocular Melanoma
• Lung Cancer
• Melanoma
• Melanoma (Skin)
• Nervous System Neoplasms
• Neuroblastoma
• Retinoblastoma
• Sarcoma
• Uveal Neoplasms

Intervention

Radiation:
• iodine I 131 monoclonal antibody 3F8

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation