Clinical trial · Interventional

Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms

NCT00003022CI-TRIAL-00011199completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (7)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain and Central Nervous System Tumors	—	UNRESOLVED	—
Intraocular Melanoma	Uveal Melanoma	ALIAS	0.90
Lung Cancer	Malignant Lung Neoplasm	CURATED_EXACT	0.92
Melanoma (Skin)	Melanoma	ONTOLOGY_EXACT	0.85
Neuroblastoma	Neuroblastoma	ONTOLOGY_EXACT	0.90
Retinoblastoma	Retinoblastoma	ONTOLOGY_EXACT	0.98
Sarcoma	Sarcoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
iodine I 131 monoclonal antibody 3F8	Radiation	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 3 Years

Show eligibility criteria text

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

References

Publications (1)

RESULTKramer 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 18048828

Registry

Dates and enrollment

Start: Apr 1, 1997
Primary completion: Jan 1, 2005
Completion: Jan 1, 2005
First posted: Jan 27, 2003
Last update posted: Jul 3, 2013
Lead sponsor: Memorial Sloan Kettering Cancer Center OTHER
Collaborators: National Cancer Institute (NCI)
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

Brief summary (as posted)

Conditions (7)

Interventions (1)

Eligibility (as posted)

Publications (1)

Locations by country (1)