NCT00006347

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

March 3, 2009

Status Verified

April 1, 2003

First QC Date

October 4, 2000

Last Update Submit

February 28, 2009

Conditions

Lung Cancer

Keywords

recurrent small cell lung cancer

Interventions

indium In 111 monoclonal antibody MN-14RADIATION
yttrium Y 90 monoclonal antibody MN-14RADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Garden State Cancer Center

Belleville, New Jersey, 07109, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsSmall Cell Lung Carcinoma

Interventions

Indium

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • Jack D. Burton, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2000

First Posted

January 27, 2003

Study Start

August 1, 2000

Last Updated

March 3, 2009

Record last verified: 2003-04

Locations

US(1)