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Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer Clinical research trials and Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer. Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer  Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
For Condition: Recurrent Small Cell Lung Cancer
Status: No longer recruiting
Sponsor(s): Garden State Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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/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% Pulmonary: - FEV1 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 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JackBurton, Study Chair, Garden State Cancer Center
Garden State Cancer Center
Belleville, New Jersey, 07109
United States
Additional Information:
Study ID Numbers: CDR0000068199; CMMI-C-057A-99,NCI-H00-0064
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006347
Other Recurrent Small Cell Lung Cancer Studies:
1. Phase I/II Study of Lepirudin in Patients with Recurrent or Extensive Stage Small Cell Lung Cancer
2. Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer
3. Cisplatin, Etoposide, and Cyclophosphamide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
4. Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
5. Marimastat Following Chemotherapy in Treating Patients With Small Cell Lung Cancer
Related Studies:
Other Recurrent Small Cell Lung Cancer Clinical Trials
Other New Jersey Clinical Trials
Other Belleville Clinical Trials
Monoclonal Antibody Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
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