NCT00003022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 1997

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1997

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

7.8 years

First QC Date

November 1, 1999

Last Update Submit

July 1, 2013

Conditions

Brain and Central Nervous System TumorsIntraocular MelanomaLung CancerMelanoma (Skin)NeuroblastomaRetinoblastomaSarcoma

Keywords

metastatic osteosarcomachildhood infratentorial ependymomarecurrent childhood rhabdomyosarcomachildhood supratentorial ependymomaregional neuroblastomadisseminated neuroblastomastage 4S neuroblastomarecurrent neuroblastomaretinoblastomaintraocular retinoblastomaextraocular retinoblastomarecurrent retinoblastomaextensive stage small cell lung cancerrecurrent small cell lung cancerrecurrent osteosarcomarecurrent adult brain tumoriris melanomaciliary body and choroid melanoma, small sizeciliary body and choroid melanoma, medium/large sizeextraocular extension melanomarecurrent intraocular melanomaadult brain stem gliomaadult medulloblastomastage IV melanomarecurrent melanomametastatic childhood soft tissue sarcomarecurrent childhood soft tissue sarcomaadult myxopapillary ependymomaadult anaplastic ependymomaadult anaplastic oligodendrogliomaadult mixed gliomalocalized unresectable neuroblastomaadult ependymoblastomarecurrent childhood brain stem gliomarecurrent childhood supratentorial primitive neuroectodermal tumorrecurrent childhood visual pathway gliomarecurrent childhood medulloblastomarecurrent childhood visual pathway and hypothalamic gliomapreviously treated childhood rhabdomyosarcomalocalized Ewing sarcoma/peripheral primitive neuroectodermal tumormetastatic Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent childhood ependymomaadult oligodendrogliomaadult anaplastic astrocytomaadult supratentorial primitive neuroectodermal tumor (PNET)adult diffuse astrocytomaadult pilocytic astrocytomaadult giant cell glioblastomaadult glioblastomaadult gliosarcoma

Interventions

iodine I 131 monoclonal antibody 3F8RADIATION

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related 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. 2007 Dec 1;25(34):5465-70. doi: 10.1200/JCO.2007.11.1807.

    PMID: 18048828RESULT

MeSH Terms

Conditions

Central Nervous System NeoplasmsUveal MelanomaLung NeoplasmsMelanomaNeuroblastomaRetinoblastomaSarcomaOsteosarcomaSmall Cell Lung CarcinomaBrain NeoplasmsMedulloblastomaEpendymomaOligodendrogliomaGliomaNeuroectodermal Tumors, PrimitiveOptic Nerve GliomaNeuroectodermal Tumors, Primitive, PeripheralFamilial ependymomaAstrocytomaGlioblastomaGliosarcoma

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasUveal NeoplasmsEye NeoplasmsEye DiseasesUveal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, NeuroepithelialNeoplasms, Glandular and EpithelialRetinal NeoplasmsEye Diseases, HereditaryRetinal DiseasesNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueNeoplasms, Connective TissueCarcinoma, BronchogenicBronchial NeoplasmsBrain DiseasesCentral Nervous System DiseasesOptic Nerve NeoplasmsCranial Nerve NeoplasmsPeripheral Nervous System NeoplasmsCranial Nerve DiseasesOptic Nerve Diseases

Study Officials

  • Kim Kramer, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1, 1997

Primary Completion

January 1, 2005

Study Completion

January 1, 2005

Last Updated

July 3, 2013

Record last verified: 2013-07

Locations

US(1)