Iodine I 131 Monoclonal Antibody 3F8 in Treating Patients With Central Nervous System Cancer or Leptomeningeal Cancer

NCT00445965 | Completed Phase 2 Results

• 2 other identifiers: 05-122MSKCC-05122
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8, can find tumor cells and carry tumor-killing substances to them without harming normal cells. This may be an effective treatment for central nervous system cancer or leptomeningeal metastases. PURPOSE: This phase II trial is studying the side effects and how well iodine I 131 monoclonal antibody 3F8 works in treating patients with central nervous system cancer or leptomeningeal cancer.

Conditions

Brain and Central Nervous System Tumors; Intraocular Melanoma; Lung Cancer; Melanoma (Skin); Metastatic Cancer; Neuroblastoma; Ovarian Cancer; Retinoblastoma; Sarcoma; Small Intestine Cancer

Keywords

recurrent childhood medulloblastoma; untreated childhood medulloblastoma; adult supratentorial primitive neuroectodermal tumor (PNET); recurrent childhood supratentorial primitive neuroectodermal tumor; untreated childhood supratentorial primitive neuroectodermal tumor; adult anaplastic astrocytoma; adult diffuse astrocytoma; adult pilocytic astrocytoma; adult subependymal giant cell astrocytoma; recurrent childhood subependymal giant cell astrocytoma; untreated childhood subependymal giant cell astrocytoma; recurrent childhood cerebellar astrocytoma; recurrent childhood cerebral astrocytoma; untreated childhood cerebellar astrocytoma; adult brain stem glioma; adult mixed glioma; childhood mixed glioma; recurrent childhood brain stem glioma; recurrent childhood visual pathway and hypothalamic glioma; recurrent childhood visual pathway glioma; untreated childhood brain stem glioma; untreated childhood visual pathway and hypothalamic glioma; untreated childhood visual pathway glioma; regional neuroblastoma; disseminated neuroblastoma; recurrent neuroblastoma; extraocular retinoblastoma; recurrent retinoblastoma; adult anaplastic ependymoma; adult ependymoblastoma; adult ependymoma; adult myxopapillary ependymoma; adult subependymoma; childhood infratentorial ependymoma; childhood supratentorial ependymoma; recurrent childhood ependymoma; childhood atypical teratoid/rhabdoid tumor; recurrent melanoma; stage IV melanoma; adult medulloblastoma; chondrosarcoma; metastatic osteosarcoma; recurrent osteosarcoma; metastatic childhood soft tissue sarcoma; ovarian sarcoma; recurrent childhood soft tissue sarcoma; stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; previously treated childhood rhabdomyosarcoma; recurrent childhood rhabdomyosarcoma; adult anaplastic oligodendroglioma; adult desmoplastic small round cell tumor; adult oligodendroglioma; adult giant cell glioblastoma; adult gliosarcoma; tumors metastatic to brain; adult rhabdomyosarcoma; childhood oligodendroglioma; childhood desmoplastic small round cell tumor; extensive stage small cell lung cancer; intraocular retinoblastoma; recurrent adult brain tumor; recurrent adult soft tissue sarcoma; recurrent uterine sarcoma; small intestine leiomyosarcoma; recurrent small intestine cancer; recurrent small cell lung cancer; extraocular extension melanoma; recurrent intraocular melanoma; metastatic intraocular melanoma; iris melanoma; ciliary body and choroid melanoma, medium/large size; newly diagnosed childhood ependymoma; adult glioblastoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent childhood pineoblastoma; untreated childhood pineoblastoma; adult pineal gland astrocytoma; stage IIIA melanoma; stage IIIB melanoma; stage IIIC melanoma; recurrent childhood anaplastic astrocytoma; untreated childhood anaplastic astrocytoma; recurrent childhood anaplastic oligoastrocytoma; recurrent childhood anaplastic oligodendroglioma; untreated childhood anaplastic oligoastrocytoma; untreated childhood anaplastic oligodendroglioma; recurrent childhood giant cell glioblastoma; recurrent childhood glioblastoma; untreated childhood giant cell glioblastoma; untreated childhood glioblastoma; recurrent childhood gliosarcoma; untreated childhood gliosarcoma; recurrent childhood gliomatosis cerebri; untreated childhood gliomatosis cerebri; childhood high-grade cerebellar astrocytoma; childhood high-grade cerebral astrocytoma

Outcome Measures

Primary Outcomes (2)

• Six-month Overall Survival

  6 months

• Number of Participants With Response at 6 Months

  Complete Response (CR): Cytologic and radiographic CR will be evaluated separately, since patients with cytologic clearing and clinical response may continue to have residual abnormalities on MRI scans. Patients with a CR must also have stable or improved neurologic exam. Stable Disease (SD): Exists when a patient fails to fulfill the criteria for either complete or partial response or progressive disease. Progressive Disease (PD): An increase of at least 50% in the absolute number of malignant cells in the CSF OR, in -solid tumor patients, an increase of greater than 25% in the size of measurable lesions on MR scan OR the recurrence of malignant cells in the CSF or new lesions on MR after a patient has attained a complete remission OR evidence of clinical neurologic progression. New sites of or increasing evidence of leptomeningeal enhancement that is not "measurable" will also be considered evidence of disease progression.

  6 months

Secondary Outcomes (1)

• Number of Participants Evaluable for Toxicities

  1 year

Study Arms (1)

131I-3F8

EXPERIMENTAL

This is a phase II single-arm open-label study that will define responses to therapy with weekly intrathecal 131I-3F8 in patients with central nervous system/leptomeningeal GD2-expressing disease.

Genetic: DNA analysis; Other: immunologic technique; Other: pharmacological study; Radiation: iodine I 131 monoclonal antibody 3F8; Radiation: 131I-3F8

Interventions

DNA analysis GENETIC

131I-3F8

immunologic technique OTHER

131I-3F8

pharmacological study OTHER

131I-3F8

iodine I 131 monoclonal antibody 3F8 RADIATION

131I-3F8

131I-3F8 RADIATION

Patients will receive 10mCi intrathecal 131I-3F8 per week. Patients will be pre-medicated with dexamethasone to prevent possible meningeal inflammatory reaction, Liothyronine and SSKI to prevent thyroid accumulation, and acetaminophen and diphenhydramine in anticipation of possible allergic reaction and fever.

131I-3F8

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a histologically confirmed diagnosis of a malignancy known to expressGD2. Such tumors include medulloblastoma/primitive neuroectodermal tumor of the CNS, high grade astrocytomas, malignant glioma, neuroblastoma, retinoblastoma, ependymoma, rhabdoid tumors, sarcomas, melanoma or small cell lung carcinoma. For patients with other tumor types, GD2 expression must be confirmed by immunohistochemical staining and assessed by the Department of Pathology using prior frozen tissue, bone marrow or CSF cytology (send to Research Lab).
• Patients must have CNS/ leptomeningeal disease including high risk medulloblastoma, or a CNS/leptomeningeal malignancy which is refractory to conventional therapies, or for which no conventional therapy exists, OR a recurrent brain tumors with a predilection for leptomeningeal dissemination (medulloblastoma, PNET, rhabdoid tumor).
• Patients must have an absolute neutrophil count (ANC) \> 1000/ul and a platelet count \> 50,000/ul.
• Patients may have active malignancy outside the central nervous system.
• Patients who have a programmable shunt will not be excluded.
• Both pediatric and adult patients of any age are eligible.
• Patients or a legal guardian will sign an informed consent form approved by the IRB and obtained by the Principal or a Co- Investigator before patient entry. Minors will provide assent.

You may not qualify if:

• Patients with obstructive or symptomatic communicating hydrocephalus.
• Patients with an uncontrolled life-threatening infection.
• Patients who are pregnant: Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is required during the study period.
• Patients who have received cranial or spinal irradiation less than 3 weeks prior to the start of this protocol.
• Patients who have received systemic chemotherapy (corticosteroids not included) less than 3 weeks prior to the start of this protocol.
• Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity should all be less than or equal to grade 2. Patients with stable neurological deficits (because of their brain tumor) are not excluded. Patients with \<= 3 hearing loss are not excluded.
• Patients must have no rapidly progressing or deteriorating neurologic examination.
• Patients who have already received \>45 Gy to the craniospinal radiation or \>72 Gy focal brain radiation.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Uveal Melanoma; Lung Neoplasms; Melanoma; Neoplasm Metastasis; Neuroblastoma; Ovarian Neoplasms; Retinoblastoma; Sarcoma; Medulloblastoma; Astrocytoma; Glioma; Optic Nerve Glioma; Ependymoma; Neuroectodermal Tumors, Primitive; Glioma, Subependymal; Familial ependymoma; Rhabdoid Tumor; Chondrosarcoma; Osteosarcoma; Oligodendroglioma; Desmoplastic Small Round Cell Tumor; Glioblastoma; Gliosarcoma; Brain Neoplasms; Rhabdomyosarcoma; Small Cell Lung Carcinoma; Neuroectodermal Tumors, Primitive, Peripheral; Neoplasms, Neuroepithelial

Interventions

Immunologic Techniques

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Eye Diseases; Uveal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Glandular and Epithelial; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Retinal Neoplasms; Eye Diseases, Hereditary; Retinal Diseases; Neoplasms, Connective and Soft Tissue; Optic Nerve Neoplasms; Cranial Nerve Neoplasms; Peripheral Nervous System Neoplasms; Cranial Nerve Diseases; Optic Nerve Diseases; Neoplasms, Complex and Mixed; Neoplasms, Connective Tissue; Neoplasms, Bone Tissue; Brain Diseases; Central Nervous System Diseases; Myosarcoma; Neoplasms, Muscle Tissue; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Dr. Kim Kramer MD
• Organization: Memorial Sloan Kettering Cancer Center

kramerk@MSKCC.ORG

212-639-6410

Study Officials

• Kim Kramer, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2007
• First Posted: March 9, 2007
• Study Start: January 1, 2006
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: April 4, 2024
• Results First Posted: April 4, 2024

Record last verified: 2023-02

Locations

US (1)