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Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia Clinical research trials and Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia healthcare trials occur in a lot of of places throughout 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 potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia. Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia clinical trial. Participants typically obtain the most effective healthcare available for their Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia  Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
For Condition: relapsing chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of vaccine therapy in treating patients who have chronic myelogenous leukemia.
Details: OBJECTIVES: I. Determine the safety and immunogenicity of a multivalent tumor-specific breakpoint peptide vaccine in patients with chronic myelogenous leukemia. II. Determine the antileukemic effects of vaccination with these peptides in these patients. PROTOCOL OUTLINE: Patients receive bcr/abl breakpoint peptide vaccine in QS21 adjuvant subcutaneously at rotated sites every 1-3 weeks (on or about days 0, 7, 21, 35, and 56) over 8 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients demonstrating a response by week 10 may receive 3 additional monthly vaccinations initiated within 8 weeks of the fifth dose. Patients demonstrating a response by vaccination 8 may receive 3 additional vaccinations administered at two-month intervals. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven chronic myelogenous leukemia - Must have (9;22) translocation or bcr/abl transcript, and b3a2 breakpoint - No accelerated or blastic phase Must be in hematologic remission with peripheral WBC less than 20,000/mm3 --Prior/Concurrent Therapy-- Biologic therapy: - At least 6 months since prior allogeneic or autologous bone marrow transplantation - Prior vaccination with pentavalent peptide at less than study dose level allowed - At least 4 weeks since prior immunotherapy other than interferon, donor lymphocyte infusion, or pentavalent vaccine Concurrent interferon allowed Chemotherapy: - At least 2 weeks since prior low-dose subcutaneous cytarabine - At least 4 weeks since prior chemotherapy other than hydroxyurea - No concurrent chemotherapy except hydroxyurea Endocrine therapy: No concurrent corticosteroids Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: No concurrent surgery Other: - Concurrent imatinib mesylate allowed - No other concurrent systemic therapy --Patient Characteristics-- Age: Over 16 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: - See Disease Characteristics - Absolute granulocyte count greater than 1,200/mm3 - Platelet count greater than 70,000/mm3 - Hemoglobin greater than 9.0 g/dL - No active bleeding Hepatic: - Bilirubin less than 2.0 mg/dL - Lactate dehydrogenase less than 2 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Other: - No uncontrolled active infection requiring antibiotics - No other serious illness - No immunodeficiency other than from prior bone marrow transplantation - Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
KathleenCathcart, Study Chair, Memorial Sloan-Kettering Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067247; MSKCC-99012,NCI-H99-0036
Study Start Date: March 1999
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004052
Other Relapsing Chronic Myelogenous Leukemia Studies:
1. Imatinib Mesylate With or Without Interferon Alfa or Cytarabine Compared With Interferon Alfa Followed by Allogeneic Stem Cell Transplantation in Treating Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia
2. Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
3. Homoharringtonine Plus Low-Dose Cytarabine in Treating Patients With Newly Diagnosed Chronic Myelogenous Leukemia in Chronic Phase
4. Chemotherapy and Peripheral Stem Cell Transplantation Followed by Immunotherapy in Treating Patients With Chronic Myelogenous Leukemia
5. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Related Studies:
Other relapsing chronic myelogenous leukemia Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Vaccine Therapy in Treating Patients With Chronic Myelogenous Leukemia
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