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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006458
First received: November 6, 2000
Last updated: February 28, 2009
Last verified: October 2001
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Radiation: indium In 111 monoclonal antibody MN-14
Radiation: yttrium Y 90 monoclonal antibody MN-14
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Advanced Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2000
Detailed Description:

OBJECTIVES: I. 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 non-small cell lung cancer. II. Determine the dosimetric and pharmacokinetic properties of this treatment regimen in the blood, normal organs, and tumors of these patients. III. Determine the stability and complexation with circulating carcinoembryonic antigen of this radioantibody in the plasma of these patients. IV. Determine the antibody response of these patients with this treatment regimen. V. 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 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006458

Locations
United States, New Jersey
Garden State Cancer Center
Belleville, New Jersey, United States, 07103
Sponsors and Collaborators
Garden State Cancer Center at the Center for Molecular Medicine and Immunology
Investigators
Study Chair: Jack D. Burton, MD Garden State Cancer Center at the Center for Molecular Medicine and Immunology
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00006458     History of Changes
Other Study ID Numbers: CDR0000068198, CMMI-C-047A-99, NCI-H00-0063
Study First Received: November 6, 2000
Last Updated: February 28, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
squamous cell lung cancer
large cell lung cancer
adenocarcinoma of the lung
adenosquamous cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014