|
Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome Clinical research trials and Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome. Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome clinical trial. Test subjects typically receive the most effective healthcare possible for their Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome  Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
For Condition: childhood acute myeloid leukemia and other myeloid malignancies,adult acute myeloid leukemia,Chronic Myelogenous Leukemia,atypical chronic myeloid leukemia,myelodysplastic and myeloproliferative disease
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from peptides that are found on leukemia cells may make the body build an immune response and kill cancer cells. Combining vaccine therapy with the immune adjuvantMontanide ISA-51 may be a more effective treatment for chronic myeloid leukemia,acute myeloid leukemia, or myelodysplastic syndrome. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy plus Montanide ISA-51 in treating patients who have chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndrome.
Details: OBJECTIVES: - Determine the toxicity and immunological activity of PR1 leukemia peptide vaccine administered with Montanide ISA-51 in patients with chronic myeloid leukemia, acute myeloid leukemia, or myelodysplastic syndromes. - Evaluate possible clinical efficacy of this vaccine in high-risk HLA-A2-positive patients with myeloid leukemias. OUTLINE: This is a phase I dose-escalation study of PR1 leukemia peptide vaccine, followed by a phase II randomized study. Patients receive PR1 leukemia peptide vaccine with Montanide ISA-51 (ISA-51) subcutaneously (SC) once every 3 weeks for 9 weeks, for a total of 3 vaccinations. Patients also receive sargramostim (GM-CSF) SC with each vaccination. Cohorts of 3 patients receive escalating doses of PR1 leukemia peptide vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity. Additional patients are accrued to the phase II portion of the study and are randomized to receive one of three dose levels of PR1 leukemia peptide vaccine with ISA-51. Patients in each of the 3 arms receive treatment as in the phase I portion of the study. Patients achieving a clinical response or immune reaction to the vaccine are followed monthly until death or until the clinical response and/or immune reaction is lost. PROJECTED ACCRUAL: A total of 3-9 patients will be accrued for the phase I dose escalation portion of this study. A maximum of 60 patients (20 per arm) will be accrued for the phase II randomized portion of this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of chronic myeloid leukemia in chronic phase or early accelerated phase - Ineligible for bone marrow transplantation (BMT) or interferon OR - Failed standard therapy OR - Relapsed after BMT OR - Diagnosis of 1 of the following diseases and not a candidate for chemotherapy: - Myelodysplastic syndromes in second or subsequent remission - Refractory anemia with excess blasts (RAEB) OR - RAEB in transformation - Acute myeloid leukemia (AML) in second or subsequent remission - AML with a smoldering presentation - HLA-A2 positive at one allele PATIENT CHARACTERISTICS: Age: - Over 18 Performance status: - ECOG 0-2 Life expectancy: - At least 9 weeks Hematopoietic: - Not specified Hepatic: - Bilirubin less than 3 mg/dL - ALT less than 3 times upper limit of normal Renal: - Creatinine less than 2 mg/dL Pulmonary: - FEV, FVC, and DLCO greater than 50% of predicted - No symptomatic pulmonary disease Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other concurrent illness that severely limits life expectancy - No known history of Wegener's granulomatosis or other vasculitis - No known allergy to Montanide ISA-51 - No active uncontrolled infection - No serologic antibody against proteinase 3 - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - No concurrent interferon Chemotherapy: - See Disease Characteristics - No concurrent chemotherapy except hydroxyurea to control cell counts Endocrine therapy: - At least 1 month since prior steroids - No concurrent steroids Radiotherapy: - Not specified Surgery: - Not specified Other: - At least 1 month since prior cyclosporine or tacrolimus - No concurrent cyclosporine or tacrolimus
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyMolldrem, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77230-1402
United States
Recruiting Jeffrey Molldrem 713-563-3334
Additional Information:
Study ID Numbers: CDR0000067600; MDA-DM-97325,NCI-T98-0017
Study Start Date:
Record last reviewed: December 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004918
Other Myelodysplastic And Myeloproliferative Disease Studies:
1. Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia
2. Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
3. Fludarabine and Busulfan Followed by Allogeneic Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia in First Complete Remission
4. Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
5. Cyclosporine, Daunorubicin, and Cytarabine in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Related Studies:
Other myelodysplastic and myeloproliferative disease Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
|
|
|
|
|
|
|
|
