Melanoma Clinical Trial

Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

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.

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Full 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.

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Eligibility 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

Study is for people with:

Melanoma

Phase:

Phase 1

Study ID:

NCT00003022

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States

How clear is this clinincal trial information?

Study is for people with:

Melanoma

Phase:

Phase 1

Study ID:

NCT00003022

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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