Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer

Garden State Cancer Center at the Center for Molecular Medicine and Immunology

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lung Cancer

Interventions

indium In 111 monoclonal antibody MN-14RADIATION

yttrium Y 90 monoclonal antibody MN-14RADIATION

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Garden State Cancer Center

Belleville, New Jersey, United States

Data from ClinicalTrials.gov

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