Symptoms and General Pathology

All Conditions

Neoplasms

Rare Diseases

Recurrence

Neuroblastoma

Neuroectodermal Tumors, Primitive, Peripheral

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Central Nervous System Depressants

Micronutrients

Anti-Infective Agents

Other Dietary Supplements

Antibodies

Antibodies, Monoclonal

Bevacizumab

Lenograstim

Immunoglobulins

Benzocaine

Iodine

Cadexomer iodine

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

Tannic Acid

Patients will be administered a therapeutic doses of intravenous (IV) 131I-3F8 given in a single dose per the dose escalation regimen on day 0 of study. This will be followed by blood draws for pharmacokinetic and dosimetry studies and by gamma camera scan, where feasible. Bevacizumab will be administered at a fixed dose of 15mg/kg on days 1 and 15. Thyroid protection is commenced 10 days prior to administration of 131I-3F8 and continued for 28 days after the therapeutic dose of 131I-3F8. ASCR will be carried out if ANC \< 500/ul on day 28 (blood radioactivity will be confirmed to be \<1 uCi/ml prior to ASCR). ASCR will be carried out sooner in the case of life-threatening infection in the setting of neutropenia (ANC\<500). G-CSF can be used to maintain ANC\>500/ul but should not be used for 24 hours immediately before and after ASCR. Blood product support will be provided with platelet and red cell transfusions as required.

bevacizumab

filgrastim

autologous hematopoietic stem cell transplantation

iodine I 131 monoclonal antibody 3F8

Shakeel Modak, MD

Nai-Kong V. Cheung, MD, PhD

RATIONALE: Monoclonal antibodies, such as iodine I 131 monoclonal antibody 3F8 and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of neuroblastoma by blocking blood flow to the tumor. Giving iodine I 131 monoclonal antibody 3F8 together with bevacizumab may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of iodine I 131 monoclonal antibody 3F8 when given together with bevacizumab in treating patients with relapsed or refractory neuroblastoma.

OBJECTIVES:

Primary

* Determine the toxicity of iodine I 131 monoclonal antibody 3F8 (\^131I-3F8) and bevacizumab in patients with relapsed or refractory neuroblastoma.
* Determine the hematopoietic recovery after autologous stem cell rescue in patients treated with this regimen.

Secondary

* Determine the clinical response rates in patients treated with this regimen.
* Assess whole body dosimetry for \^131I-3F8.
* Assess tumor targeting of \^131I-3F8 before and after bevacizumab.

OUTLINE: This is a dose-escalation study of iodine I 131 monoclonal antibody 3F8 (\^131I-3F8).

Patients receive \^131I-3F8 IV over 20-30 minutes on day 0 and bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 4 courses. Patients whose blood counts do not recover and whose human antimouse antibody (HAMA) titer \< 1,000 U/mL after course 1 receive one dose of \^131I-3F8 alone followed by autologous stem cell rescue (ASCR) and filgrastim (G-CSF). Patients whose blood counts do not recover and whose HAMA titer ≥ 1,000 U/mL after course 1 undergo ASCR followed by G-CSF. Patients whose blood counts recover and whose HAMA titer \< 1,000 U/mL after course 1 receive 3 more courses of \^131I-3F8 and bevacizumab in the absence of disease progression or unacceptable toxicity.

Cohorts of 6 patients receive escalating doses of \^131I-3F8 and bevacizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed at 3-4 weeks and then every 3-6 months thereafter.

Iodine I 131 Monoclonal Antibody 3F8 and Bevacizumab in Treating Patients With Relapsed or Refractory Neuroblastoma

Combination of Targeted I -3F8-Mediated Radioimmunotherapy and Bevacizumab in Patients With Relapsed or Refractory Neuroblastoma: A Phase I Study

National Cancer Institute (NCI)

Memorial Sloan Kettering Cancer Center

Nervous System Diseases

Central Nervous System Neoplasms

Medulloblastoma

Nervous System Neoplasms

Glioma

Medulloblastoma, Childhood

Vincristine

Cisplatin

Lomustine

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

This is a single-arm study of post-operative radioimmunotherapy (intrathecal 131-I-3F8), reduced-dose craniospinal radiation therapy (1800 cGy), primary site boost (to 5400 cGy) via IMRT and standard chemotherapy.

cisplatin

lomustine

vincristine sulfate

adjuvant therapy

radiation therapy

Ira Dunkel, MD

RATIONALE: Radioimmunotherapy uses radiolabeled monoclonal antibodies to locate tumor cells and deliver radioactive tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining intrathecal radioimmunotherapy and radiation therapy with combination chemotherapy may kill any tumor cells remaining after surgery.

PURPOSE: Phase II trial to study the effectiveness of combining intrathecal radioimmunotherapy and radiation therapy with combination chemotherapy in treating patients who have undergone surgery for medulloblastoma.

OBJECTIVES:

* Determine the feasibility of combining post-operative intrathecal radioimmunotherapy, craniospinal radiotherapy with intensity-modulated radiotherapy boost, and chemotherapy in patients with standard-risk medulloblastoma.
* Determine whether this regimen can maintain or exceed the current progression-free survival rate while decreasing long-term serious morbidity in these patients.
* Determine the long-term morbidities, most specifically neuropsychological, neuroendocrine, audiometric, and growth outcomes, in patients treated with this regimen.

OUTLINE:

* Radioimmunotherapy: Patients receive intrathecal iodine I 131 monoclonal antibody 3F8 on days 1 and 8.
* Radiotherapy: Beginning as soon as possible after radioimmunotherapy, patients undergo external-beam and intensity-modulated radiotherapy 5 days a week for 6 weeks.
* Chemotherapy: Patients receive vincristine IV once weekly for 8 weeks concurrently with radiotherapy. Beginning about 6 weeks after completion of radiotherapy (4 weeks after vincristine), patients receive cisplatin IV over 6 hours and oral lomustine on day 0 and vincristine IV on days 0, 7, and 14. Treatment repeats every 6 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study within 3.2 years.

Intrathecal Radioimmunotherapy, Radiation Therapy, and Chemotherapy After Surgery in Treating Patients With Medulloblastoma

A Trial Of Radioimmunotherapy, Reduced-Dose External Beam Craniospinal Radiation Therapy With IMRT Boost, And Chemotherapy For Patients With Standard-Risk Medulloblastoma

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Iodine I 131 Monoclonal Antibody 3F8 and Bevacizumab in Treating Patients With Relapsed or Refractory Neuroblastoma	NCT00450827	Neuroblastoma	bevacizumab filgrastim autologous hema... iodine I 131 mo...	1 Year -	Memorial Sloan Kettering Cancer Center
Intrathecal Radioimmunotherapy, Radiation Therapy, and Chemotherapy After Surgery in Treating Patients With Medulloblastoma	NCT00058370	Brain and Centr...	cisplatin lomustine vincristine sul... adjuvant therap... iodine I 131 mo... radiation thera...	3 Years -	Memorial Sloan Kettering Cancer Center

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