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AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate Clinical research trials and AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate. AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate  AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate
AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate
For Condition: chronic phase chronic myelogenous leukemia,Philadelphia chromosome positive chronic myelogenous leukemia
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Vaccines made from a person's white blood cells, such as AG-858, may make the body build an immune response to kill cancer cells. Combining AG-858 with imatinib mesylate may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining AG-858 with imatinib mesylate in treating patients who are currently receiving imatinib mesylate for chronic phase chronic myelogenous leukemia.
Details: OBJECTIVES: Primary - Determine complete cytogenetic response rates in patients with chronic phase chronic myelogenous leukemia who are cytogenetically positive after prior treatment with imatinib mesylate and are now treated with AG-858 while continuing imatinib mesylate. Secondary - Determine the substantial molecular response rates in patients treated with this regimen. - Determine the frequency and severity of adverse events in patients treated with this regimen. - Determine the feasibility of AG-858 production in these patients. OUTLINE: This is an open-label, multicenter study. Patients are stratified according to cytogenetic status. Patients continue to receive oral imatinib mesylate on their pre-study schedule. Patients undergo leukapheresis for the production of AG-858. Patients receive AG-858 intradermally once weekly for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 4 and 16 weeks. PROJECTED ACCRUAL: A total of 60-120 patients (20-40 per stratum) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia (CML) - In first chronic phase - In complete hematologic response - Currently receiving imatinib mesylate for CML in 1 of the following settings: - As first therapy for CML - After prior therapy with interferon alfa, cytarabine, busulfan, hydroxyurea, or any combination thereof - Cytogenetic status meets criteria for 1 of the following: - Less than a complete cytogenetic response (CCR) after receiving imatinib mesylate* for at least 1 year - Must have received a stable dose of imatinib mesylate for the last 6 months - Stable cytogenetic status without CCR (neither response nor progression) by 3 consecutive determinations over 6 months while receiving imatinib mesylate* - Cytogenetic progression by 2 determinations at least 1 month apart while receiving imatinib mesylate* NOTE: *At least 400 mg/day - Not a candidate for curative bone marrow transplantation PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Bilirubin no greater than 2 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No New York Heart Association class III or IV heart disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study participation - No autoimmune disorder - No other malignancy within the past 5 years except adequately treated cone-biopsied carcinoma in situ of the cervix or basal cell or squamous cell skin cancer - No severe active infection - No other serious medical illness that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior allogeneic bone marrow transplantation - No concurrent routine growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], or epoetin alfa) Chemotherapy - See Disease Characteristics Endocrine therapy - No concurrent corticosteroids Radiotherapy - Not specified Surgery - Not specified Other - See Disease Characteristics - No other prior therapy for CML - No other concurrent anticancer therapies - No concurrent cyclosporine - No concurrent immunosuppressants
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RonaldPaquette, Principal Investigator, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095
United States
Recruiting Charles Sawyers 310-206-5585
Additional Information:
Study ID Numbers: CDR0000334026; UCLA-0304072,ANTIGENICS-C-300-01
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070395
Other Philadelphia Chromosome Positive Chronic Myelogenous Leukemia Studies:
1. Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase
2. Bevacizumab, Idarubicin, and Cytarabine in Treating Patients With Blast Phase Chronic Myelogenous Leukemia
3. Homoharringtonine Compared With Hydroxyurea for Chronic Myelogenous Leukemia That Has Not Responded to Interferon alfa
4. Interferon alfa Plus Sargramostim in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
5. BMS-354825 in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia That Is Resistant to Imatinib Mesylate
Related Studies:
Other Philadelphia chromosome positive chronic myelogenous leukemia Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
AG-858 and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Were Previously Treated With Imatinib Mesylate
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