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BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors 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 BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors Clinical research trials and BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors 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 BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors. BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors 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 BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors clinical trial. Test subjects typically receive the most expert healthcare available for their BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors 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 > "B" Clinical Trials Conditions > BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors  BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors
BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors
For Condition: gastrointestinal carcinoid tumor,pulmonary carcinoid tumor,Small Cell Lung Cancer,Non-small cell lung cancer,adult solid tumor,Neuroendocrine Carcinoma
Status: Recruiting
Sponsor(s): British Biotech Pharmaceuticals ,
Synopsis: RATIONALE: Monoclonal antibodies such as BB-10901 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of BB-10901 in treating patients who have recurrent or refractory lung cancer, metastaticcarcinoid tumor, or other solid tumors.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of BB-10901 in patients with recurrent or refractory small cell lung cancer, other pulmonary tumors of neuroendocrine origin, non-pulmonary small cell carcinoma, metastatic carcinoid tumor, or other CD56+ solid tumors. - Determine the safety and tolerability of this drug in these patients. - Determine the efficacy of this drug in these patients. Secondary - Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is an open-label, dose-escalation, multicenter study. - Patients receive BB-10901 IV over 2 hours once weekly for 4 weeks. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who show evidence of response after 4 courses may receive additional treatment for up to a total of 6 courses. Cohorts of 3-6 patients receive escalating doses of BB-10901 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive BB-10901 IV over 2 hours at the MTD determined in phase I. Patients are followed at 1 month. PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed diagnosis of 1 of the following: - Small cell lung cancer (SCLC) (phase I and II) - Other pulmonary tumor of neuroendocrine origin*, including neuroendocrine carcinoma and non-small cell lung cancer with neuroendocrine features - Non-pulmonary small cell carcinoma* - Metastatic carcinoid tumor* - Other CD56+ solid tumor* NOTE: *Phase I only - Diagnoses other than SCLC must have confirmation of tumor CD56 expression before study entry - Relapsed or refractory, defined as the following: - Relapsed (phase I and II): - Initially responded (partial or complete) to first-line therapy and then relapsed more than 3 months after completion of the last chemotherapy regimen - Refractory (phase I only): - Failed to respond to or relapsed within 3 months of completion of the last chemotherapy regimen - Unidimensionally measurable disease - At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No uncontrolled carcinoid syndrome (e.g., flushing, uncontrolled diarrhea, or labile blood pressure) - No known CNS metastases PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-2 Life expectancy - At least 3 months Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST/ALT no greater than 3 times ULN (5 times ULN if liver metastases are present) Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No grade 3 or 4 cardiac toxicity after prior chemotherapy - No myocardial infarction within the past 6 months - No ischemic stroke within the past 6 months - No unstable angina pectoris - No uncontrolled congestive heart failure - No uncontrolled arrhythmia - No severe aortic stenosis - No history of hemorrhagic stroke Neurologic - No grade 3 or 4 neurological toxicity after prior chemotherapy - No history of multiple sclerosis or other demyelinating disease - No CNS injury with residual neurologic deficit - No Eaton-Lambert syndrome (para-neoplastic syndrome) Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able and willing to tolerate and comply with study requirements - No chronic alcoholism - No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix - No concurrent herpes zoster (shingles) or cytomegalovirus infection or history of recurrent infection with these viruses - No concurrent serious infection - No other concurrent significant illness that would preclude study outcome PRIOR CONCURRENT THERAPY: Biologic therapy - No prior monoclonal antibody therapy - No other concurrent antineoplastic immunotherapy Chemotherapy - See Disease Characteristics - More than 4 weeks since prior chemotherapy - No more than 3 prior chemotherapy regimens (phase I) - No more than 1 prior chemotherapy regimen (phase II) - No concurrent antineoplastic chemotherapy Endocrine therapy - No concurrent antineoplastic steroid therapy Radiotherapy - More than 4 weeks since prior radiotherapy - No concurrent antineoplastic radiotherapy Surgery - No concurrent surgery, including elective surgery Other - More than 4 weeks since other prior investigational agents - No other concurrent antineoplastic treatment - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrankFossella, , M.D. Anderson Cancer Center
San Antonio Cancer Institute *Recruiting*
San Antonio, Texas, 78229-3264
United States
Recruiting Anthony Tolcher 210-616-5914
Baystate Medical Center *Recruiting*
Springfield, Massachusetts, 01107
United States
Recruiting John McCann 413-794-3316
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Frank Fossella 713-792-6363
Additional Information:
Study ID Numbers: CDR0000343705; EU-20318,BBIO-C10/IVB/001
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00074256
Other Gastrointestinal Carcinoid Tumor Studies:
1. Radiofrequency Ablation in Treating Patients With Refractory or Advanced Lung Cancer
2. Fluorouracil Plus Interferon Alfa in Treating Patients With Advanced Metastatic Carcinoid Tumors
3. BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors
Related Studies:
Other gastrointestinal carcinoid tumor Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
BB-10901 in Treating Patients With Recurrent or Refractory Lung Cancer, Metastatic Carcinoid Tumor, or Other Solid Tumors
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