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Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction 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 ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer Clinical research trials and Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction 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 ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer. Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction 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 ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer clinical trial. Test subjects typically receive the most expert healthcare available for their Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction 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 ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer  Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
For Condition: Esophageal Cancer,Lung Cancer,Pancreatic Cancer,kidney tumor,Colorectal Cancer,Prostate Cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as ABX-EGF 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 ABX-EGF in treating patients who have either renal (kidney), prostate, pancreatic, non-small cell lung, colon, rectal, esophageal, or gastroesophageal junction cancer.
Details: OBJECTIVES: - Determine the safety of monoclonal antibody ABX-EGF in patients with renal, prostate, pancreatic, non-small cell lung, colorectal, esophageal, or gastroesophageal junction cancer. - Determine the pharmacokinetics and the dose-response relationship of this drug in this patient population. - Evaluate the clinical effect of this drug in this patient population. OUTLINE: This is an open-label, dose-escalation, multicenter study. Patients receive monoclonal antibody ABX-EGF IV over 1 hour once weekly on weeks 0-3* (enrollment for the weekly dosing schedule completed as of 4/21/03 [with the exception of patients undergoing full pharmacokinetic analyses, described below]) OR once every 2 weeks on weeks 0, 2, 4, and 6* OR once every 3 weeks on weeks 0, 3, 6, and 9*. Patients undergoing full pharmacokinetic analyses receive a loading dose on week 0 and the subsequent 3 doses on weeks 3-5. NOTE: *All patients receive a total of 4 doses. Cohorts of 2-8 patients receive escalating doses of monoclonal antibody ABX-EGF until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 or 3 patients experience dose-limiting toxicity. Patients are followed every 2 weeks for 5 weeks. PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within approximately 14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of 1 of the following: - Renal cell cancer (RCC) - Prior nephrectomy required - Prostate cancer - Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy) - Failed prior hormonal therapy (e.g., antiandrogen, luteinizing hormone-releasing hormone inhibitor, or orchiectomy) - Pancreatic cancer - Failed at least 1 prior standard therapy regimen for unresectable metastatic disease - Non-small cell lung cancer - Failed at least 1 prior standard therapy regimen for unresectable metastatic disease - Colorectal cancer - Received 1 or more prior chemotherapy regimen(s) for advanced metastatic disease - Esophageal cancer - Failed prior primary therapy (e.g., surgery, radiotherapy, or chemotherapy) - Gastroesophageal junction cancer - Evaluable disease - Epidermal growth factor receptor overexpression - Tumor tissue must yield the sum of 1+, 2+, or 3+ staining in at least 10% of evaluated tumor cells - No uncontrolled brain metastases - No evidence of disease progression or regression after a 30-day washout period PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 70-100% OR - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - AST/ALT no greater than 2 times upper limit of normal (ULN) (3 times ULN for liver metastases) - Alkaline phosphatase no greater than 2 times ULN (3 times ULN for liver metastases) Renal: - Creatinine less than 2.2 mg/dL - NCI renal toxicity no greater than grade 2 - No hypercalcemia (antihypercalcemic therapy allowed) Cardiovascular: - Ejection fraction at least 45% by MUGA - No abnormal ECG or MUGA - No myocardial infarction within the past year Pulmonary: - No abnormal chest x-ray - FEV_1 greater than 50% of predicted Other: - No known allergy to ingredients of study drug - No known allergy to Staphylococcus aureus Protein A - HIV negative - No chronic medical or psychiatric condition that would preclude study compliance - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 30 days since prior biologic therapy (e.g., antibodies, cytokines, or co-stimulatory pathway inhibitors) - No other concurrent biologic therapy Chemotherapy: - See Disease Characteristics - At least 6 weeks since prior chemotherapy and recovered - No prior chemotherapy for RCC - No prior anthracyclines - No concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - Concurrent steroids allowed - Concurrent hormonal therapy allowed Radiotherapy: - See Disease Characteristics - No prior mediastinal radiotherapy - No concurrent radiotherapy Surgery: - See Disease Characteristics - Recovered from any recent prior surgery Other: - At least 30 days since prior investigational drug or device - At least 30 days since prior systemic therapy - No other concurrent investigational drugs - No other concurrent systemic agents or cancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ArieBelldegrun, Principal Investigator, Jonsson Comprehensive Cancer Center
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Louis Weiner 215-728-2480
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1738
United States
Recruiting Arie Belldegrun 310-825-1094
Additional Information:
Study ID Numbers: CDR0000067539; UCLA-9906078,ABX-EG-9901,UCLA-9906078-04B,NCI-G00-1673
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004879
Other Esophageal Cancer Studies:
1. Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
2. A Study to Test the Effectiveness of Virulizin® Given in Combination with Standard Chemotherapy for Pancreatic Cancer
3. Diagnostic and Genetic Study to Identify Pancreatic Lesions in Patients With Von Hippel-Lindau Syndrome
4. CI-1040 in Treating Patients With Advanced Breast, Colon, Pancreatic, or Non-Small Cell Lung Cancer
5. Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
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Monoclonal Antibody ABX-EGF in Treating Patients With Renal (Kidney), Prostate, Pancreatic, Non-Small Cell Lung, Colon or Rectal, Esophageal, or Gastroesophageal Junction Cancer
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