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Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer Clinical research trials and Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer. Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "R" Clinical Trials Conditions > Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer  Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer
Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer
For Condition: medullary thyroid cancer
Status: No longer recruiting
Sponsor(s): Garden State Cancer Center ,
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/80 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven medullary thyroid carcinoma; Unresectable local-regional disease OR Distant metastases - Autologous peripheral blood stem cells (PBSC) or bone marrow available - Diffuse bone/marrow involvement allowed if: Autologous bone marrow or PBSC with no greater than 5% tumor involvement available; Radiation dose to marrow no greater than 3000 cGy until 6 patients have been treated safely at that dose level - At least 1 site confirmed by CT targeted by pretherapy indium; In 111 monoclonal antibody MN-14 imaging --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since biologic therapy - Chemotherapy: At least 4 weeks since prior chemotherapy and recovered; No greater than 240 mg/m2 doxorubicin total for combination therapy with doxorubicin but no greater than 550 mg/m2 doxorubicin if radioimmunotherapy alone; No prior failure on doxorubicin therapy for combination therapy but not radioimmunotherapy alone - Endocrine therapy: Prior synthroid (T4) allowed - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy to index lesion and recovered; No prior radiotherapy to greater than 35% of red marrow - Surgery: At least 4 weeks since prior major surgery --Patient Characteristics-- - Age: 16 to 80 - Performance status: Karnofsky 60-100%; ECOG 0-2 - Life expectancy: At least 3 months - Hematopoietic: WBC at least 3000/mm3; Granulocyte count at least 1500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 2 mg/dL - Renal: Creatinine less than 1.5 times upper limit of normal - Cardiovascular: Ejection fraction at least 50% - Other: No severe anorexia, nausea, or vomiting; No concurrent significant medical complications that would preclude compliance; Not pregnant; Fertile patients must use effective contraception during and for 3 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JackBurton, Study Chair, Garden State Cancer Center
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
Garden State Cancer Center
Belleville, New Jersey, 07103
United States
Additional Information:
Study ID Numbers: CDR0000067172; CMMI-C-040A-98,NCI-V99-1564,CMMI-FDR001555
Study Start Date: September 1998
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004048
Other Medullary Thyroid Cancer Studies:
1. Thalidomide in Treating Patients With Thyroid Cancer
2. Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer
Related Studies:
Other medullary thyroid cancer Clinical Trials
Other New Jersey Clinical Trials
Other Belleville Clinical Trials
Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer
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