Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004048|
Recruitment Status : Completed
First Posted : April 15, 2004
Last Update Posted : June 22, 2011
RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver tumor-killing substances to them without harming normal cells. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radioimmunotherapy or chemotherapy used to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of radioimmunotherapy with or without doxorubicin plus peripheral stem cell transplantation in treating patients who have thyroid cancer.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Biological: filgrastim Drug: doxorubicin hydrochloride Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: indium In 111 monoclonal antibody MN-14 Radiation: yttrium Y 90 monoclonal antibody MN-14||Phase 1 Phase 2|
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicities of high dose yttrium Y 90 monoclonal antibody MN-14 with or without doxorubicin plus peripheral blood stem cell rescue in patients with medullary thyroid cancer. II. Correlate organ and tumor dosimetry with toxicity and antitumor responses in these patients. III. Assess response and duration of response in these patients after this treatment.
OUTLINE: This is a dose escalation study of yttrrium Y 90 monoclonal antibody MN-14 (90Y-MN-14). Patients are stratified by prior doxorubicin (yes vs no). Patients receive filgrastim (G-CSF) subcutaneously (SQ) on days -11 to -7 and undergo leukapheresis on days -8 to -6. If an adequate number of CD34+ cells are not harvested, bone marrow is also collected. Patients receive pretherapy targeting consisting of indium In 111 monoclonal antibody MN-14 (In111-MN-14) on day 0. At least 1 confirmed tumor site must be targeted. Patients receive 90Y-MN-14 IV over 30-45 minutes on day 7. Some patients also receive doxorubicin IV on day 8. PBSC or bone marrow is reinfused on approximately day 7-14. Patients also receive G-CSF SQ or IV until blood counts recover. Cohorts of 3-6 patients receive escalating radiological doses of 90Y-MN-14 until the maximum tolerated dose (MTD) is determined. The MTD is defined as either the dose at which no more than 1 of 6 patients experiences dose limiting toxicity or the threshold radiation doses to lungs, kidneys, and liver. Patients are followed weekly for the first month, monthly for 3 months, then every 6 months for up to 5 years.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for each stratum of this study within 3 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Official Title:||Phase I/II Radioimmunotherapy With High-Dose 90Y-Labeled Humanized MN-14 Alone or Combined With Doxorubicin and Peripheral Blood Stem Cell Rescue (PBSCR) in Medullary Thyroid Cancer (MTC) Grant Application Title: Radioimmunotherapy of MTC With Y-90 Humanized MN14 Anti-CEA Mab and Doxorubicin|
|Study Start Date :||September 1998|
|Primary Completion Date :||May 2002|
|Study Completion Date :||May 2002|
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): NCT00004048
|United States, New Jersey|
|Garden State Cancer Center|
|Belleville, New Jersey, United States, 07103|
|St. Joseph's Hospital and Medical Center|
|Paterson, New Jersey, United States, 07503|
|Study Chair:||Jack D. Burton, MD||Garden State Cancer Center at the Center for Molecular Medicine and Immunology|