Radioimmunotherapy With or Without Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Thyroid Cancer
Condition: Head and Neck Cancer
MeSH terms: Thyroid Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): filgrastim; doxorubicin hydrochloride; autologous bone marrow transplantation; peripheral blood stem cell transplantation; indium In 111 monoclonal antibody MN-14; yttrium Y 90 monoclonal antibody MN-14
Intervention type(s): Biological; Drug; Procedure; Procedure; Radiation; Radiation
Intervention MeSH terms: Antineoplastic Agents, Immunological; Doxorubicin; Liposomal doxorubicin; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Primary purpose: Treatment
Keywords: thyroid gland medullary carcinoma