|
Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies Clinical research trials and Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies. Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies clinical trial. Participants oftentimes recieve the finest healthcare available for their Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "S" Clinical Trials Conditions > Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies  Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies
Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies
For Condition: Neoplasms
Status: No longer recruiting
Sponsor(s): Neopharm , Georgetown University
Synopsis: LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein produced by human cells, both normal and cancerous, which may help protect tumor cells from radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount of a certain target protein by blocking the gene that makes it. Antisense oligonucleotide to raf gene can reduce the amount of Raf-1 protein in tumor cells. Liposomes are tiny globules of fat, which can carry drugs in the body. The experimental agent LErafAON is composed of liposomes carrying antisense oligonucleotide against the Raf-1 protein. It is hoped that decreased Raf-1 in the cancer cells will make them more sensitive to the radiation therapy. Patients with advanced malignancies will receive daily IV infusions of LErafAON for 2 weeks (total of 10 doses) during clinically indicated palliative radiotherapy. Cohorts of at least three patients will be entered at escalating dose-levels. Each cohort will be observed for toxicity for at least two weeks after completion of treatment with study medication before the next cohort is enrolled. The study will be stopped when a maximum tolerated dose (MTD) is identified. Dose escalation within a patient will not be allowed. Safety and supportive care requirements will be assessed.
Details: OBJECTIVES: I. Determine the toxicity and MTD of LErafAON administered in daily I.V. infusions, in combination with radiotherapy, to patients with advanced malignancies. II. Characterize the plasma pharmacokinetics of LErafAON after IV infusion. III. Assess in vivo inhibition of Raf-1 protein by LErafAON. IV. Determine efficacy in radiated and non-radiated tumors. PROTOCOL OUTLINE: This study is a traditional Phase I MTD study. Cohorts of at least three patients will be entered at escalating dose-levels. Patients will receive daily IV infusions of LErafAON for 2 weeks (total of 10 doses). Each cohort will be observed for at least two weeks post treatment with study medication to allow for observation of toxicity before the next cohort is enrolled. Dose escalation will proceed until the MTD is identified. Dose escalation within a patient will not be allowed. PROJECTED ACCRUAL: Up to 27 patients; at least 3 per dose level, expanded to 6 if dose-limiting toxicity (DLT) occurs.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: -Disease Characteristics- Histologically-confirmed malignancy which has recurred or progressed after initial definitive treatment and/or for which no curative therapy is available. Palliative radiation therapy indicated for disease and site. (More than one lesion may be treated with radiation therapy.) At least 30 days must have elapsed since receiving an investigational agent, at least 21 days since receiving any prior chemotherapy or radiation, and at least six weeks since receiving nitrosourea-containing therapy; patient must have recovered from any related side effects. The site for radiotherapy, the index lesion, must have a measurable or evaluable tumor documented no more than 4 weeks prior to having study-related procedures. More than one lesion may be present and treated with radiotherapy. Additional lesions, not treated with radiotherapy, may also be present. Previously irradiated sites will NOT be irradiated in this study. -Patient Characteristics- Performance Status (ECOG/ZUBROD) of 0-2. Must be at least 18 years of age. Must have adequate organ function: Absolute neutrophil count at least 1,500/mm3; Platelets at least 100,000/mm3; Creatinine, Calcium, and total Bilirubin not higher than the upper limit of normal; Liver enzymes AST and ALT not more than 2.5 x the upper limit of normal; PT and aPTT not more than the upper limit of normal. Life expectancy more than 12 weeks. Must sign Informed Consent. Planned treatment site(s) has not had previous radiation therapy. Patients must not have concurrent antitumor therapy other than that planned in the study. No history of Grade 4 toxicity from prior radiation therapy. (Grade 3 toxicity from prior radiation therapy, at investigator discretion.) No infection requiring parenteral antibiotics; no HIV infection; no chronic hepatic disease; and no seropositivity for Hepatitis B and Hepatitis C. (Use of prophylactic antibiotics is permitted.) No pregnant or lactating females. All females of child-bearing potential must use an effective method of contraception. No active central nervous system (CNS) metastasis. Neuroimaging is required only if metastasis is suggested by history or physical examination.
Total Enrollment: 25
Location and Contact Information:
Overall Study Official:
AnatolyDritschilo, Principal Investigator, Georgetown University
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Georgetown University
Washington D.C., District of Columbia, 20007
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Temple University Cancer Center
Philadelphia, Pennsylvania, 19140
United States
Additional Information:
Study ID Numbers: LErafAON-001;
Study Start Date: March 2001
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00024648
Other Neoplasms Studies:
1. A Safety and Effectiveness Study of Aroplatin in Patients with Advanced Solid Malignancies
2. A Pharmacokinetic Study of Valacyclovir in Pediatric Oncology Patients
3. Safety Study of rhuMAb 2C4 to Treat Advanced Solid Tumors
4. Dose Determination of 5-Fluorouracil in Combination with Leucovorin and the Experimental Drug UCN-01 to Treat Cancer
5. Collection of Blood from Patients with Cancer
Related Studies:
Other Neoplasms Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Study to Determine Maximum Tolerated Dose of LErafAON Combined with Radiotherapy in Patients with Advanced Malignancies
|
|
|
|
|
|
|
|
