Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Intraocular Melanoma Lung Cancer Melanoma (Skin) Neuroblastoma Retinoblastoma Sarcoma |
Radiation: iodine I 131 monoclonal antibody 3F8 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms |
| Study Start Date: | April 1997 |
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.
Eligibility| Ages Eligible for Study: | 3 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Kim Kramer, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00003022 History of Changes |
| Other Study ID Numbers: | CDR0000065607, MSKCC-97021, NCI-G97-1267 |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 22, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
metastatic osteosarcoma childhood infratentorial ependymoma recurrent childhood rhabdomyosarcoma childhood supratentorial ependymoma regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma recurrent neuroblastoma retinoblastoma intraocular retinoblastoma extraocular retinoblastoma recurrent retinoblastoma extensive stage small cell lung cancer recurrent small cell lung cancer recurrent osteosarcoma |
recurrent adult brain tumor iris melanoma ciliary body and choroid melanoma, small size ciliary body and choroid melanoma, medium/large size extraocular extension melanoma recurrent intraocular melanoma adult brain stem glioma adult medulloblastoma stage IV melanoma recurrent melanoma metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma adult myxopapillary ependymoma adult anaplastic ependymoma adult anaplastic oligodendroglioma |
Additional relevant MeSH terms:
|
Lung Neoplasms Melanoma Nervous System Neoplasms Neuroblastoma Retinoblastoma Central Nervous System Neoplasms Neuroectodermal Tumors, Primitive Uveal Neoplasms Neuroectodermal Tumors, Primitive, Peripheral Meningeal Neoplasms Sarcoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
Lung Diseases Respiratory Tract Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas Nervous System Diseases Neoplasms, Neuroepithelial Neoplasms, Glandular and Epithelial Retinal Neoplasms Eye Neoplasms Eye Diseases Retinal Diseases |
ClinicalTrials.gov processed this record on May 22, 2013