|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00089245 |
Purpose
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances, such as radioactive iodine, to them without harming normal cells.
PURPOSE: This phase I trial is studying the side effects and best dose of radiolabeled monoclonal antibody therapy in treating patients with refractory, recurrent, or advanced CNS or leptomeningeal metastases.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Neuroblastoma Sarcoma |
Radiation: iodine I 131 monoclonal antibody 8H9 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous System/Leptomeningeal Neoplasms |
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2004 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive iodine I 131 monoclonal antibody 8H9 (^131I MOAB 8H9)* intrathecally on day 1. Treatment repeats every 4 weeks for up to 2 courses (total of 2 injections) in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of ^131I MOAB 8H9 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
NOTE: *Patients with stored stem cells will be treated at the escalating dose while patients with no stem cells will be treated at a stablished dose. Neuroblastoma patients can be treated at the stablished dose with or without stored stem cells.
PROJECTED ACCRUAL: A total of 3-80 patients will be accrued for this study within 2-3 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed CNS or leptomeningeal cancer, meeting 1 of the following criteria:
Refractory to conventional therapy OR for which no conventional therapy exists
Recurrent brain tumor or other solid tumor with a predilection for leptomeningeal dissemination, including, but not limited to, the following:
No rapidly progressing or deteriorating neurologic examination
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No other severe major organ toxicity
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Kim Kramer, MD 212-639-6410 kramerk@mskcc.org | |
| Study Chair: | Kim Kramer, MD | Memorial Sloan-Kettering Cancer Center |
| Investigator: | Nai-Kong V. Cheung, MD, PhD | Memorial Sloan-Kettering Cancer Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00089245 History of Changes |
| Other Study ID Numbers: | CDR0000378183, MSKCC-03133 |
| Study First Received: | August 4, 2004 |
| Last Updated: | March 18, 2011 |
| Health Authority: | Unspecified |
|
leptomeningeal metastases recurrent neuroblastoma disseminated neuroblastoma recurrent adult brain tumor recurrent childhood medulloblastoma recurrent childhood rhabdomyosarcoma recurrent childhood soft tissue sarcoma recurrent osteosarcoma recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor childhood atypical teratoid/rhabdoid tumor |
adult medulloblastoma previously treated childhood rhabdomyosarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor metastatic osteosarcoma childhood desmoplastic small round cell tumor metastatic childhood soft tissue sarcoma adult rhabdomyosarcoma recurrent adult soft tissue sarcoma stage IV adult soft tissue sarcoma |
|
Nervous System Neoplasms Neuroblastoma Central Nervous System Neoplasms Neuroectodermal Tumors, Primitive, Peripheral Meningeal Neoplasms Sarcoma Neoplasms by Site Neoplasms Nervous System Diseases Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Connective and Soft Tissue Antibodies Immunoglobulins Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |