Expired Study
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Belleville, New Jersey 07109


RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have relapsed or refractory small cell lung cancer.

Study summary:

OBJECTIVES: - Determine the dose limiting toxicity and maximum tolerated dose of yttrium Y 90 anti-CEA monoclonal antibody MN-14 in patients with relapsed or refractory small cell lung cancer. - Determine the dosimetric and pharmacokinetic properties of this treatment regimen in the blood, normal organs, and tumors of these patients. - Determine the stability and complexation with circulating carcinoembryonic antigen of this radioantibody in the plasma of these patients. - Determine the antibody response of these patients treated with this regimen. - Determine the antitumor effects of this treatment regimen in these patients. OUTLINE: This is a dose escalation study of yttrium Y 90 anti-CEA monoclonal antibody MN-14 (90Y-hMN-14). Patients are stratified according to prior radiotherapy (yes vs no). Patients undergo pretherapy imaging with indium In 111 anti-CEA monoclonal antibody MN-14 IV over 30-40 minutes on day -7 or -6 followed by external scintigraphy on days -7 or -6 to 0. Patients who show positive localization of at least one documented tumor site receive 90Y-hMN-14 IV over 30-40 minutes on day 0. Cohorts of 3-6 patients receive escalating doses of 90Y-hMN-14 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed at 2, 4, 8, and 12 weeks; every 3 months for 2 years; and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 10-14 months.


DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed small cell lung cancer (SCLC) - Must have received at least one prior course of standard chemotherapy and, if indicated, up to 6,900 cGy of thoracic radiotherapy - Patients who received prior radiotherapy must show evidence of progressive disease - Patients who received no prior radiotherapy to the primary tumor must show evidence of stable or progressive disease - Measurable disease - Must have evidence of carcinoembryonic antigen (CEA) production or expression documented by one of the following: - Serum CEA at least 10 ng/mL - Positive immunohistology of either the primary tumor or a metastasis with CEA specific monoclonal antibody - Must have unilateral bone marrow biopsy with less than 25% tumor involvement - No known, active brain metastases PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2 mg/dL - AST no greater than 2 times upper limit of normal (ULN) - No hepatitis B or C - No other serious liver abnormality Renal: - Creatinine no greater than 1.5 times ULN - No urinary incontinence Cardiovascular: - Ejection fraction at least 50% Pulmonary: - FEV_1 and FVC at least 60% - DLCO at least 50% predicted Other: - No severe anorexia, nausea, or vomiting - No other significant medical problems - No prisoners - No reactivity to humanized MN-14 (in patients with prior exposure to chimeric or humanized antibody) - HIV negative - No active HIV-related disease - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months following study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - See Chemotherapy - No concurrent growth factors (e.g., filgrastim [G-CSF]) Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy - No prior high dose chemotherapy with stem cell transplantation Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy - Prior radiotherapy to less than 30% of red marrow (including standard chest x-ray for limited stage SCLC) allowed Surgery: - At least 4 weeks since prior major surgery



Primary Contact:

Study Chair
Jack D. Burton, MD
Garden State Cancer Center at the Center for Molecular Medicine and Immunology

Backup Contact:


Location Contact:

Belleville, New Jersey 07109
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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