NCT00006458

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 radiolabeled monoclonal antibody therapy in treating patients who have relapsed or refractory non-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
3 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2000

Completed
3.4 years until next milestone

First Posted

Study publicly available on registry

April 2, 2004

Completed
Last Updated

March 3, 2009

Status Verified

October 1, 2001

First QC Date

November 6, 2000

Last Update Submit

February 28, 2009

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancersquamous cell lung cancerlarge cell lung canceradenocarcinoma of the lungadenosquamous 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 non-small cell lung cancer Adenocarcinoma, squamous large cell, or mixed cell histology Patients with nonadenocarcinomatous 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 received at least one prior regimen of standard chemotherapy and, if indicated, no greater than 6,900 cGy thoracic radiotherapy Patients with stage IIIA/B unresectable disease who received prior radiotherapy must show evidence of progressive disease (greater than 25% increase in primary tumor or appearance of new lesions) Patients with stage IIIB or IV disease who received no prior radiotherapy to the primary or index lesion must show evidence of stable or progressive disease by CT scans at least 4 weeks apart Less than 25% tumor involvement in bone marrow 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/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 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% by MUGA Pulmonary: FEV1 at least 60% DLCO at least 50% 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 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation after high-dose chemotherapy No concurrent growth factors Chemotherapy: See Disease Characteristics See Biologic At least 4 weeks since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Prior radiotherapy to less than 30% of red marrow 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, 07103, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell LungAdenocarcinoma of Lung

Interventions

Indium

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

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

November 6, 2000

First Posted

April 2, 2004

Study Start

August 1, 2000

Last Updated

March 3, 2009

Record last verified: 2001-10

Locations

US(1)