Head and Neck Cancer Clinical Trial
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
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | May 2002 |
Est. primary completion date | May 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 80 Years |
Eligibility |
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 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 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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Garden State Cancer Center | Belleville | New Jersey |
United States | St. Joseph's Hospital and Medical Center | Paterson | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Garden State Cancer Center at the Center for Molecular Medicine and Immunology |
United States,
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