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PS-341 in Treating Patients With Hematologic Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on PS-341 in Treating Patients With Hematologic Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. PS-341 in Treating Patients With Hematologic Cancer Clinical research trials and PS-341 in Treating Patients With Hematologic Cancer healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as PS-341 in Treating Patients With Hematologic Cancer. PS-341 in Treating Patients With Hematologic Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a PS-341 in Treating Patients With Hematologic Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their PS-341 in Treating Patients With Hematologic Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > PS-341 in Treating Patients With Hematologic Cancer  PS-341 in Treating Patients With Hematologic Cancer
PS-341 in Treating Patients With Hematologic Cancer
For Condition: Leukemia,Lymphoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering 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 hematologic cancer.
Details: OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of PS-341 in patients with hematologic malignancies. II. Determine the pharmacodynamics of this drug in these patients. III. Determine response to this drug in these patients. IV. Determine the correlation between response of malignancies and proteasome inhibition and apoptosis in peripheral blood mononuclear cells (PBMC) of these patients. V. Determine the correlation between therapy toxicity and proteasome inhibition and apoptosis in PBMC of these patients. VI. Determine the effect of this drug on other molecular markers (i.e., BCL-2 in follicular lymphoma patients and t9;22/BCR/ABL in chronic lymphocytic leukemia patients). VII. Determine the correlation between interleukin 6 serum levels in multiple myeloma patients and drug dosing, toxicity of therapy, extent of protease inhibition, response to therapy, and apoptosis in PBMC of these patients. PROTOCOL OUTLINE: This is a multicenter, dose-escalation study. Patients receive PS-341 IV over 30 minutes on days 1, 4, 8, 11, 15, 18, 22, and 25 followed by a 2 week rest. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. 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 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 3-30 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 hematologic malignancy including: Acute myeloid leukemia; Chronic myelogenous leukemia; Acute lymphoblastic leukemia; Chronic lymphocytic leukemia; Hodgkin's disease; Non-Hodgkin's lymphoma; Multiple myeloma; Myelodysplastic syndrome subtypes: Refractory anemia with excess blasts (RAEB) RAEB in transformation - Refractory to standard treatment or no curative therapy available - Measurable disease - Not eligible for higher priority study --Prior/Concurrent Therapy-- - Biologic therapy: At least 4 weeks since prior immunotherapy; No concurrent immunotherapy - Chemotherapy: At least 4 weeks since prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since prior radiotherapy; No concurrent radiotherapy - Surgery: At least 2 weeks since prior major surgery --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 6 weeks - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,000/mm3; Platelet count at least 50,000/mm3; Hematocrit at least 25% - Hepatic: SGOT and SGPT less than 2.5 times upper limit of normal (ULN); Bilirubin less than 1.5 times ULN - Renal: Creatinine clearance greater than 50 mL/min - Cardiovascular: No acute ischemia or new conduction system abnormalities by EKG; No prior myocardial infarction within past 6 months; No New York Heart Association class III or IV congestive heart failure - Other: Febrile episodes up to 38.5 degrees C due to tumor fever allowed; No concurrent active infection; No grade 1 or greater National Cancer Institute common toxicity criteria; No serious medical or psychiatric condition that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenSoignet, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000068105; NCI-G00-1827,MSKCC-00031
Study Start Date: April 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006098
Other Leukemia Studies:
1. Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment
2. VNP40101M in Treating Patients With Advanced or Metastatic Cancer
3. Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
4. Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
5. Biological Therapy in Treating Patients Undergoing Radiation Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation for Hematologic Cancer
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PS-341 in Treating Patients With Hematologic Cancer
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