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| Sponsors and Collaborators: |
Garden State Cancer Center and Center for Molecular Medicine and Immunology National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006347 |
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 monoclonal antibody therapy in treating patients who have relapsed or refractory 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 I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Non-Myeloablative Trial With 90Y-Humanized MN-14 (Anti-CEA) Antibody for Relapsed or Refractory Small Cell Lung Cancer (SCLC) |
| Study Start Date: | August 2000 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed small cell lung cancer (SCLC)
Must have evidence of carcinoembryonic antigen (CEA) production or expression documented by one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, New Jersey | |
| Garden State Cancer Center | |
| Belleville, New Jersey, United States, 07109 | |
| Study Chair: | Jack D. Burton, MD | Garden State Cancer Center and Center for Molecular Medicine and Immunology |
More Information
| Study ID Numbers: | CDR0000068199, CMMI-C-057A-99, NCI-H00-0064 |
| Study First Received: | October 4, 2000 |
| Last Updated: | February 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006347 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent small cell lung cancer |
|
Thoracic Neoplasms Immunologic Factors Carcinoma, Neuroendocrine Recurrence Carcinoma Neuroendocrine Tumors Antibodies, Monoclonal Carcinoma, Small Cell Neuroectodermal Tumors |
Antibodies Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Immunoglobulins Neoplasms, Glandular and Epithelial |
|
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Immunologic Factors Carcinoma, Neuroendocrine Physiological Effects of Drugs Neoplasms, Nerve Tissue Pharmacologic Actions Carcinoma Neuroendocrine Tumors Antibodies, Monoclonal Carcinoma, Small Cell |
Neuroectodermal Tumors Antibodies Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Adenocarcinoma Immunoglobulins Neoplasms, Glandular and Epithelial |