Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Refractory, Recurrent, or Advanced CNS or Leptomeningeal Cancer
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|ClinicalTrials.gov Identifier: NCT00089245|
Recruitment Status : Active, not recruiting
First Posted : August 5, 2004
Last Update Posted : June 13, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Neuroblastoma Sarcoma||Drug: Iodine I 131 MOAB 8H9||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous System/Leptomeningeal Neoplasms|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||July 1, 2025|
Experimental: Radiolabeled Monoclonal Antibody Therapy
This is a Phase I trial designed to evaluate the Maximally Tolerated Dose (MTD) of intrathecal 131I-8H9. In order to find the MTD, a dose escalation scheme will be employed with patients entering in cohorts of 3 at each dose level from 10 mCi to 60 mCi and a cohort of 6 at each dose level from 70 mCi to 100 mCi.
Drug: Iodine I 131 MOAB 8H9
Patients will be injected, intrathecally, with 2 mCi 131I-Omburtamab during week 1 of a 5 week cycle.
Drug: Iodine I 131 MOAB 8H9
The dose used in this study is 50 mCi 131IOmburtamab, (averaging 5 mCi/mg Omburtamab at 50 mCi dose) which will be administered to each patient during week 2 of a 5 week cycle.
- Number of patients that have treatment related toxicities [ Time Frame: 2 years ]
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Subject Inclusion Criteria:
- Patients must have a histologically confirmed diagnosis of a malignancy known to be 8H9 reactive. 8H9 expression must be confirmed by immunohistochemical staining of tumor and assessed by the Department of Pathology or by immunofluorescence of bone marrow except for patients confirmed to have neuroblastoma.
- Patients must have CNS/ leptomeningeal disease 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 no rapidly progressing or deteriorating neurologic examination.
- 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.
- 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.
- Patients with stored stem cells will be treated at the escalating dose while patients with no stem cells will be treated at the 50 mCi dose. Neuroblastoma patients can be treated at the 50 mCi dose with or without stored stem cells.
Subject Exclusion Criteria:
- 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 grade 2. Patients with stable neurological deficits (because of their brain tumor) are not excluded. Patients with <= 3 hearing loss are not excluded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00089245
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Kim Kramer, MD||Memorial Sloan Kettering Cancer Center|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Y-mAbs Therapeutics|
|Other Study ID Numbers:||
|First Posted:||August 5, 2004 Key Record Dates|
|Last Update Posted:||June 13, 2022|
|Last Verified:||June 2022|
recurrent adult brain tumor
recurrent childhood medulloblastoma
recurrent childhood rhabdomyosarcoma
recurrent childhood soft tissue sarcoma
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
childhood atypical teratoid/rhabdoid tumor
previously treated childhood rhabdomyosarcoma
metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
childhood desmoplastic small round cell tumor
metastatic childhood soft tissue sarcoma
recurrent adult soft tissue sarcoma
stage IV adult soft tissue sarcoma
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms by Site
Nervous System Diseases
Anti-Infective Agents, Local
Physiological Effects of Drugs