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PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma 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 PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma Clinical research trials and PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma 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 PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma. PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma 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 PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma clinical trial. Participants oftentimes recieve the finest healthcare available for their PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma 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.
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Home > "P" Clinical Trials Conditions > PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma  PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma
PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma
For Condition: Leukemia,Lymphoma,Eye Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Kaplan Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of PS-341 in treating patients who have advanced solid tumors or lymphoma that have not responded to previous treatment.
Details: OBJECTIVES: I. Determine the dose-limiting toxicity and maximum tolerated dose of PS-341 in patients with advanced solid tumors or lymphoma. II. Evaluate the pharmacodynamics of this drug by measuring 20S proteasome inhibition in these patients. III. Assess changes in P53 or P27, and possibly E2F-1 and cyclin E, in patients with lymphoma in response to this drug. IV. Evaluate objective tumor response to this drug in these patients. V. Evaluate the relationship between toxicity and 20S proteasome inhibition in blood and in accessible tumor tissue in these patients. VI. Evaluate response to treatment with this drug in patients with measurable or evaluable disease. PROTOCOL OUTLINE: This is a dose-escalation, multicenter study. Patients receive PS-341 IV on days 1 and 4. Treatment repeats every 14 days for at least 2 courses in the absence of unacceptable toxicity or disease progression. Patients with stable or responding disease may receive additional courses at the discretion of the treating physician. Cohorts of 3-6 patients receive escalating doses of PS-341 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A maximum of 27 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed advanced solid tumor or lymphoma that has failed standard therapy and no standard options available - No leukemia or myeloma - CNS lesions allowed if adequately treated by surgery and/or radiotherapy and symptomatically stable on maintenance glucocorticoids and not requiring anticonvulsants for at least 3 months --Prior/Concurrent Therapy-- - Biologic therapy: No prior bone marrow transplantation with high-dose chemotherapy or radiolabeled monoclonal antibody therapy for lymphoma patients - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) - Endocrine therapy: See Disease Characteristics - Radiotherapy: At least 4 weeks since prior radiotherapy - Surgery: At least 2 weeks since prior major surgery - Other: See Disease Characteristics; No concurrent antiretroviral therapy --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: SGOT no greater than 2.5 times upper limit of normal; Bilirubin no greater than 1.5 mg/dL - Renal: Creatinine no greater than 1.5 mg/dL - Cardiovascular: No acute ischemia or significant conduction abnormality (i.e., bifascicular block or 2nd or 3rd degree AV blocks) - Other: No other serious medical or psychiatric illness; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
FrancoMuggia, Study Chair, Kaplan Cancer Center
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Additional Information:
Study ID Numbers: CDR0000067212; NYU-9909,NCI-T99-0047
Study Start Date: July 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004002
Other Eye Cancer Studies:
1. Amifostine to Protect From the Side Effects of Peripheral Stem Cell Transplantation in Treating Patients With High-Risk or Relapsed Solid Tumors
2. Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
3. Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer
4. Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer
5. Lymphocyte Infusion in Treating Patients With Relapsed Cancer After Bone Marrow or Peripheral Stem Cell Transplantation
Related Studies:
Other Eye Cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
PS-341 in Treating Patients With Advanced Solid Tumors or Lymphoma
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