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Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

Primary Purpose

Brain and Central Nervous System Tumors, Intraocular Melanoma, Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
iodine I 131 monoclonal antibody 3F8
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring 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, adult mixed glioma, localized unresectable neuroblastoma, adult ependymoblastoma, recurrent childhood brain stem glioma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood visual pathway glioma, recurrent childhood medulloblastoma, recurrent childhood visual pathway and hypothalamic glioma, previously treated childhood rhabdomyosarcoma, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood ependymoma, adult oligodendroglioma, adult anaplastic astrocytoma, adult supratentorial primitive neuroectodermal tumor (PNET), adult diffuse astrocytoma, adult pilocytic astrocytoma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 1, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003022
Brief Title
Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
Official Title
Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
January 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors, Intraocular Melanoma, Lung Cancer, Melanoma (Skin), Neuroblastoma, Retinoblastoma, Sarcoma
Keywords
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, adult mixed glioma, localized unresectable neuroblastoma, adult ependymoblastoma, recurrent childhood brain stem glioma, recurrent childhood supratentorial primitive neuroectodermal tumor, recurrent childhood visual pathway glioma, recurrent childhood medulloblastoma, recurrent childhood visual pathway and hypothalamic glioma, previously treated childhood rhabdomyosarcoma, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent childhood ependymoma, adult oligodendroglioma, adult anaplastic astrocytoma, adult supratentorial primitive neuroectodermal tumor (PNET), adult diffuse astrocytoma, adult pilocytic astrocytoma, adult giant cell glioblastoma, adult glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Radiation
Intervention Name(s)
iodine I 131 monoclonal antibody 3F8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Kramer, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18048828
Citation
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.
Results Reference
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Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

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