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Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors Clinical research trials and Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors 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 measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors. Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors clinical trial. Subjects typically recieve the finest healthcare available for their Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors  Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
For Condition: Head and Neck Cancer,female reproductive cancer,Gastrointestinal Cancer,thorax and respiratory cancer,unclassified and other cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating advanced solid tumors. PURPOSE: Phase I trial to study the effectiveness of immunotoxin therapy in treating patients who have recurrentunresectable advanced solid tumors.
Details: OBJECTIVES: - Determine the maximum tolerated dose of SS1(dsFv)-PE38 immunotoxin in patients with advanced mesothelin-expressing malignancies. - Determine the toxic effects of this drug in these patients. - Determine the plasma pharmacokinetics of this drug in these patients. - Determine the response in patients treated with this drug. - Correlate the induction of antibody against this drug with its pharmacokinetics in these patients. OUTLINE: This is an open-label, dose-escalation study. Patients receive a test dose of SS1(dsFv)-PE38 immunotoxin IV over 1-2 minutes on day 1 followed by SS1(dsFv)-PE38 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of SS1(dsFv)-PE38 immunotoxin 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. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 3-15 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 confirmed advanced malignancy of 1 of the following types: - Ovarian cancer - All nonmucinous epithelial histologies are eligible - Primary peritoneal cavity cancer - Fallopian tube cancer - Malignant mesothelioma - No sarcomatous histology - Pancreatic cancer - Squamous cell cancer (SCC) of the lung - SCC of the cervix - SCC of the head and neck - Recurrent unresectable disease meeting 1 of the following criteria: - Previously treated with definitive standard therapy - Patient refused prior standard therapy - Initial or recurrent tumor positive (at least 30% of tumor cells) for mesothelin by immunohistochemistry - Measurable or evaluable disease - No clinically significant pericardial effusion - No known CNS or spinal cord involvement by tumor PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 75,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN - Albumin at least 3.0 g/dL - Hepatitis B and C negative Renal - Creatinine no greater than ULN - Calcium no greater than ULN Cardiovascular - No New York Heart Association class II-IV cardiovascular condition Pulmonary - Oxygen saturation of at least 93% on room air - DLCO at least 50% of predicted* - Total lung capacity and vital capacity at least 50% of predicted* - FEV_1 at least 50% of predicted* NOTE: *For patients with pleural mesothelioma and as clinically indicated Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No infection requiring parenteral antibiotics - No HIV infection - Serum neutralizing activity to SS1(dsFv)-PE38 immunotoxin (at 200 ng/mL) no greater than 75% PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - At least 4 weeks since prior therapy and recovered - No other concurrent antitumor therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RaffitHassan, Study Chair, National Cancer Institute (NCI)
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000316451; NCI-SS1PE-002,NCI-6221,NCI-03-C-0243
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066651
Other Unclassified And Other Cancer Studies:
1. Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
2. Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
3. Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel
4. Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer
5. Docetaxel in Treating Patients With Solid Tumors
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Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors
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