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LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer Clinical research trials and LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer. LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer clinical trial. Subjects often receive the most expert healthcare possible for their LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer  LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
For Condition: Gastric Cancer,Colorectal Cancer,Pancreatic Cancer,Esophageal Cancer
Status: Recruiting
Sponsor(s): University of Freiburg , National Cancer Institute (NCI)
Synopsis: RATIONALE: LMB-9 immunotoxin can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for advanced pancreatic, esophageal, stomach, colon or rectal cancer. PURPOSE: Phase I trial to study the effectiveness of LMB-9 immunotoxin in treating patients who have advanced pancreatic, esophageal, stomach, colon, or rectal cancer.
Details: OBJECTIVES: - Determine the toxicity of LMB-9 immunotoxin in patients with advanced adenocarcinoma of the colon, rectum, pancreas, esophagus, or stomach with overexpression of the Lewis-Y antigen. - Determine the maximum tolerated dose of this drug in these patients. - Determine the clinical response of patients treated with this drug. - Determine the pharmacokinetics of this drug in these patients. OUTLINE: This is a dose-escalation study. Patients receive LMB-9 immunotoxin IV continuously on days 1-5. Patients with stable or responding disease after completion of the first course receive additional courses every 4-5 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of LMB-9 immunotoxin 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 3 weeks and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 40-50 patients will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed advanced adenocarcinoma of the colon, rectum, pancreas, esophagus, or stomach that is refractory to standard treatment - Overexpression of the Lewis-Y antigen - Measurable or evaluable disease - No CNS metastasis - Metastatic liver disease from primary tumor allowed PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - At least 3 months Hematopoietic: - Platelet count greater than 100,000/mm^3 - Absolute granulocyte count greater than 1,200/mm^3 Hepatic: - Bilirubin normal - SGOT and SGPT no greater than 1.5 times upper limit of normal - Hepatitis B or C antigen negative - No liver disease (e.g., alcohol liver disease) - Albumin at least 3.0 g/dL Renal: - Creatinine no greater than 1.4 mg/dL - Creatinine clearance at least 60 mL/min - Proteinuria no greater than 1 g/24 hours (grade II toxicity-like) Cardiovascular: - No prior coronary artery disease - No New York Heart Association class II, III, or IV congestive heart failure - No arrhythmia requiring treatment Pulmonary: - FEV_1 and FVC greater than 65% predicted Other: - No other concurrent malignancy - No active peptic ulcer disease - No known allergy to omeprazole - No known seizure disorder - No concurrent medical or psychiatric condition that would preclude study participation - No contraindication to pressor therapy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: - At least 3 weeks since prior hormonal therapy Radiotherapy: - At least 3 weeks since prior radiotherapy and recovered Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterHafkemeyer, Study Chair, University of Freiburg
Universitats Klinikum Freiburg *Recruiting*
Freiburg, , D-79106
Germany
Recruiting Peter Hafkemeyer 49-761-270-3406
Additional Information:
Study ID Numbers: CDR0000068462; UFMC-IND-7697,NCI-431,UFMC-NSC-691236,UFMC-431,EU-20120
Study Start Date:
Record last reviewed: September 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010270
Other Colorectal Cancer Studies:
1. Octreotide as Palliative Therapy for Cancer-Related Bowel Obstruction That Cannot Be Removed by Surgery
2. Study of T900607-sodium in subjects with previously treated gastric cancer or adenocarcinoma of the esophagus
3. Oblimersen, Cisplatin, and Fluorouracil in Treating Patients With Advanced Esophageal, Gastroesophageal Junction, or Stomach Cancer
4. Radiation Therapy, Combination Chemotherapy, and Amifostine Followed by Surgery to Remove the Esophagus in Treating Patients With Locally Advanced Cancer of the Esophagus
5. Radiation Therapy and Chemotherapy Before and After Surgery in Treating Patients With Esophageal Cancer
Related Studies:
Other Colorectal Cancer Clinical Trials
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Other Freiburg Clinical Trials
LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
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