Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

NCT ID: NCT00003022

Last Updated: 2013-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-04-30
• Study Completion Date: 2005-01-31

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).

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

iodine I 131 monoclonal antibody 3F8

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

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

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Kim Kramer, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 18048828 (View on PubMed)

Other Identifiers

CDR0000065607

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-G97-1267

Identifier Type: -

Identifier Source: secondary_id

97-021

Identifier Type: -

Identifier Source: org_study_id