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Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma Clinical research trials and Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma clinical trial. Subjects frequently get the best healthcare possible for their Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma  Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
For Condition: refractory chronic lymphocytic leukemia,recurrent diffuse small lymphocytic/marginal zone lymphoma
Status: No longer recruiting
Sponsor(s): Princess Margaret Hospital , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combining UCN-01 with fludarabine in treating patients who have relapsed or refractory chronic lymphocytic leukemia or lymphocytic lymphoma.
Details: OBJECTIVES: - Determine the overall response rate in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma treated with UCN-01 and fludarabine. - Assess the molecular changes in CLL cells in peripheral blood in patients treated with this regimen. - Determine the progression-free and overall survival of patients treated with this regimen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of UCN-01. Patients receive UCN-01 IV over 3 hours on day 1 and fludarabine IV over 30-60 minutes on days 1-5. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of UCN-01 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 18-46 additional patients receive UCN-01 and fludarabine as above at the recommended phase II dose. PROJECTED ACCRUAL: A total of 12 patients will be accrued for the phase I portion of this study within 6 months. A total of 18-46 patients will be accrued for the phase II portion of this study within 9-23 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed chronic lymphocytic leukemia (CLL) or B-cell small lymphocytic lymphoma (SLL) - CLL is defined as: - Persistent lymphocytosis greater than 5,000/mm^3 - CD19/CD5/CD23 positive - Kappa or lambda light chain restriction - Refractory to or disease progression after 1 or 2 prior treatment regimens - Retreatment with oral chlorambucil is allowed and considered a second regimen - At least one of the chlorambucil treatments must be for 3 months or longer - At least 4 courses of cyclophosphamide, vincristine, and prednisone with or without doxorubicin allowed - Patients may have received prior fludarabine as first- or second-line therapy if there is evidence of at least partial response and time to progression after initial fludarabine therapy was at least 12 months - No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 months Hematopoietic - See Disease Characteristics - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 - No autoimmune hemolytic anemia or thrombocytopenia secondary to CLL or SLL requiring ongoing therapy with prednisone or other immunosuppressive agents Hepatic - Bilirubin normal - AST and ALT no greater than 2.5 times upper limit of normal Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Pulmonary - DLCO greater than 60% predicted - FEV_1 greater than 70% predicted - No significant underlying pulmonary disease Other - No other malignancy within the past 5 years except adequately treated basal cell skin cancer or carcinoma in situ of the cervix - No insulin-dependent diabetes mellitus - No other uncontrolled concurrent illness - No ongoing or active infection - No pre-existing peripheral neuropathy grade 2 or greater - No psychiatric illness or social situation that would preclude study compliance - No prior allergic reactions to compounds of similar chemical or biological composition to UCN-01 or other agents in this study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy and recovered Endocrine therapy - See Hematopoietic Radiotherapy - No prior mediastinal radiation - At least 4 weeks since prior radiotherapy and recovered Surgery - Not specified Other - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelCrump, Study Chair, Princess Margaret Hospital
London Health Sciences Centre
London, Ontario, N6A 465
Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Canada
Princess Margaret Hospital at University Health Network
Toronto, Ontario, M5G 2M9
Canada
Additional Information:
Study ID Numbers: CDR0000256600; PMH-PHL-006,NCI-5538
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045513
Other Refractory Chronic Lymphocytic Leukemia Studies:
1. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
2. LMB-2 Immunotoxin in Treating Patients With Chronic Lymphocytic Leukemia
3. Pentostatin, Cyclophosphamide, and Rituximab Followed By Alemtuzumab in Treating Patients With Relapsed or Refractory B-Cell Chronic Lymphocytic Leukemia
4. Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
5. Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Related Studies:
Other refractory chronic lymphocytic leukemia Clinical Trials
Other Ontario Clinical Trials
Other London Clinical Trials
Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia or Lymphocytic Lymphoma
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