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LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases Clinical research trials and LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases. LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases clinical trial. Test subjects oftentimes recieve the best healthcare possible for their LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases  LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases
LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases
For Condition: unspecified adult solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Duke University
Synopsis: RATIONALE: LMB-7 immunotoxin can locate tumor cells and kill them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of LMB-7 immunotoxin in treating patients who have leptomeningeal metastases metastases.
Details: OBJECTIVES: I. Determine the toxicity of intrathecal LMB-7 immunotoxin in patients with leptomeningeal metastases. II. Identify objective therapeutic responses in this group of patients. PROTOCOL OUTLINE: This is a dose escalation study. Patients receive LMB-7 intrathecally on days 1, 3, and 5. Treatment may be repeated every 4 weeks if the patient does not demonstrate HAMA neutralizing antibodies to PE-38 in CSF, has stable or responding disease, and has not experienced greater than grade II toxicity. Three to six patients are entered at each dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience grade 3 or worse toxicity or a neuroradiology toxicity score of 10 or greater. PROJECTED ACCRUAL: Approximately 15 to 24 patients will be accrued over one year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven primary intracranial or extraneural neoplasm with leptomeningeal metastases - At least 30% of malignant cells in the cerebrospinal fluid, primary tumor, or metastatic tumor must react with the B3 mouse monoclonal antibody --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No chemotherapy within past 4 weeks (6 weeks for nitrosoureas) unless there is evidence of disease progression in CNS; No concurrent chemotherapy - Endocrine therapy: Patients receiving corticosteroids must be on stable dose for 10 days prior to entry - Radiotherapy: No radiotherapy to disease site within past 3 months unless there is evidence of disease progression in CNS; No concurrent radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 50-100% - Life expectancy: Not specified - Hematopoietic: ANC greater than 1000/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin less than 1.5 mg/dL - Renal: Creatinine less than 1.2 mg/dL - Pulmonary: DLCO at least 60 - Other: No neutralizing antibodies to Pseudomonas exotoxin; Not pregnant or nursing; Not allergic to penicillin
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DarellBigner, Study Chair, Duke University
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107
United States
Additional Information:
Study ID Numbers: CDR0000065605; DUMC-000428-00-3R3,DUMC-0511-99-3R2,DUMC-424-98-3R1,DUMC-460-97-3,NCI-T96-0012
Study Start Date: September 1997
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003020
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2. Erlotinib Combined With Gemcitabine in Treating Patients With Newly Diagnosed Locally Advanced or Metastatic Pancreatic Cancer or Other Solid Tumors
3. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
4. AG2037 in Treating Patients With Advanced, Metastatic, or Recurrent Solid Tumors
5. Combination Chemotherapy in Treating Patients With Advanced Cancer
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LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases
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