|
UCN-01 in Treating Patients With Advanced Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about UCN-01 in Treating Patients With Advanced Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. UCN-01 in Treating Patients With Advanced Cancer Clinical research trials and UCN-01 in Treating Patients With Advanced Cancer medical trials take place in many of places throughout 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like UCN-01 in Treating Patients With Advanced Cancer. UCN-01 in Treating Patients With Advanced Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a UCN-01 in Treating Patients With Advanced Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their UCN-01 in Treating Patients With Advanced Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "U" Clinical Trials Conditions > UCN-01 in Treating Patients With Advanced Cancer  UCN-01 in Treating Patients With Advanced Cancer
UCN-01 in Treating Patients With Advanced Cancer
For Condition: Leukemia,Lymphoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Johns Hopkins University
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of UCN-01 in treating patients with advanced cancer that has not responded to previous treatment..
Details: OBJECTIVES: I. Determine the toxicity profile, dose limiting toxicity, and maximum tolerated dose of UCN-01 administered as a 3, 2, or 1 hour infusion every 4 weeks for patients with advanced solid tumor malignancies and chronic lymphoproliferative disorders. II. Investigate the pharmacokinetics and cellular pharmacodynamics of UCN-01 administered on this schedule in these patients. III. Obtain preliminary evidence of the antitumor activity of UCN-01 in this patient population. PROTOCOL OUTLINE: This is dose escalation study. Patients receive UCN-01 by intravenous infusions over 3, 2 or 1 hour(s) every 4 weeks. The first dose level is administered over 3 hours, the next dose level is administered over 2 hours, and the next and subsequent dose levels are administered over 1 hour. One patient is treated at each dose level until unacceptable toxicity is observed. An additional 2 patients are then entered at that dose level. If dose limiting toxicity (DLT) is experienced in 1 of 3 patients, 3 additional patients are accrued at that dose level. If 2 or more patients experience DLT, the maximum tolerated dose has been surpassed and a total of 6 patients must be treated at the previous dose level. If no patients develop DLT, the dose is escalated in successive cohorts of 3 patients per dose level. Patients are followed for 4 weeks after each drug administration before subsequent patients can be entered at the next higher dose level. Patients are followed for 2 months after their last dose of UCN-01. PROJECTED ACCRUAL: Approximately 36 patients will be accrued into this study over 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed malignancy that is refractory to standard therapy or for which no standard therapy exists - Low grade lymphoproliferative disorder defined as: Chronic lymphocytic leukemia/small lymphocytic lymphoma; Waldenstrom's macroglobulinemia; Follicular lymphoma (small cleaved, mixed, and large cell); Mantle cell lymphoma; Prolymphocytic leukemia (T and B type); Cutaneous T cell non-Hodgkin's lymphoma; Marginal zone lymphoma and variants; Hairy cell leukemia variants; MALT lymphomas - Patients with low grade lymphoproliferative disorders must have received at least 1 or more treatment regimens and must not be eligible for potentially curative treatments (i.e., bone marrow transplantation) - No HTLV-1 associated lymphomas, Burkitt's or small non-cleaved lymphomas, transplant related lymphoproliferative disorders, Hodgkin's disease, diffuse large cell lymphoma, or multiple myeloma - No primary brain tumors or history of brain metastases --Prior/Concurrent Therapy-- - Biologic therapy: At least 1 month since prior platelet or red blood cell transfusions - Chemotherapy: At least 6 weeks since nitrosoureas or mitomycin; At least 4 weeks since other chemotherapy; No investigational or standard chemotherapy for at least 2 months after completion of last dose of UCN-01 - Endocrine therapy: Not specified - Radiotherapy: At least 4 weeks since radiotherapy - Surgery: At least 4 weeks since major surgery - Other: No concurrent anticonvulsant medications --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 12 weeks - Hematopoietic: Absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3; Hemoglobin at least 8.0 g/dL - Hepatic: Bilirubin no greater than 1.2 mg/dL; AST/ALT less than 2.5 times upper limit of normal - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No history of unstable or newly diagnosed angina pectoris; No myocardial infarction within the last 6 months; No New York Heart Association class II-IV congestive heart failure - Neurologic: No grade 2 or greater peripheral neuropathy - Pulmonary: No grade 2 or greater pulmonary toxicity (dyspnea on significant exertion) - Other: HIV negative; No autoimmune hemolytic anemia; Must be able to have a central venous access catheter; No active infections requiring oral or intravenous antibiotics; No medical or psychiatric problems unrelated to the malignancy that may limit compliance with study, expose patient to undue risk, or confound toxicity assessment; Not pregnant or nursing; Adequate contraception is required of all fertile patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RossDonehower, Study Chair, Johns Hopkins University
Johns Hopkins Oncology Center
Baltimore, Maryland, 21231
United States
Additional Information:
Study ID Numbers: CDR0000066221; JHOC-98012305,NCI-T97-0083
Study Start Date: June 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003289
Other Lymphoma Studies:
1. Fludarabine, Total-body Irradiation, Donor Peripheral Stem Cell Transplantation, and Donor White Blood Cell Infusions in Treating Patients With Hematologic Cancer
2. Rebeccamycin Analog and Cisplatin With or Without Filgrastim in Treating Patients With Advanced Cancer
3. High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation and Chemoprotective Therapy in Treating Patients With Cancer
4. Combination Chemotherapy With or Without Biological Therapy in Treating Patients With Refractory Solid Tumor or Lymphoma
5. Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
Related Studies:
Other Lymphoma Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
UCN-01 in Treating Patients With Advanced Cancer
|
|
|
|
|
|
|
|
