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Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome 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 Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome Clinical research trials and Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome 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 Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome. Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome 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 Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome 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 > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome  Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome
Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome
For Condition: refractory anemia with excess blasts,secondary myelodysplastic syndrome,Previously Treated Myelodysplastic Syndrome,refractory anemia with ringed sideroblasts,Refractory Anemia,de novo myelodysplastic syndrome,Chronic Myelomonocytic Leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: A vaccine made from a person's myelodysplasia cells may make the body build an immune response to kill cancer cells. Combining vaccine therapy with sargramostim may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have myelodysplastic syndrome .
Details: OBJECTIVES: I. Determine whether a specific T-cell response can be induced in patients with myelodysplastic syndrome treated with mutant N-, K-, or H-ras peptide vaccine (limited to the specific N-, K-, or H-ras peptide mutation in their bone marrow) and intradermal sargramostim (GM-CSF). II. Determine whether HLA type or the ability to respond immunologically to common recall antigens correlates with the induction of anti-ras immune responses in these patients treated with this regimen. III. Assess toxicity of mutant N-, K-, or H-ras peptide vaccine in these patients. PROTOCOL OUTLINE: Patients receive sargramostim (GM-CSF) intradermally on days 1-10. Patients receive mutant N-, K-, or H-ras peptide vaccine (limited to the specific N-, K-, or H-ras mutation in their bone marrow) intradermally on day 7. Treatment repeats every 4 weeks for up to 5 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 2 and 6 weeks after the last vaccination. PROJECTED ACCRUAL: A total of 25-70 patients will be accrued for this study over 12-15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 17 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven myelodysplastic syndrome (MDS) with 1 of the following classifications: Refractory anemia; Refractory anemia with ringed sideroblasts Refractory anemia with excess blasts; Chronic myelomonocytic leukemia; History of MDS, received chemotherapy for acute leukemia within past 12 months, and now in remission - Myelodysplastic disease must be stable (not anticipated to require chemotherapy for at least 4 months) - Must have 1 of the following N-, K-, or H-ras peptide mutations: Progenitor cells contain aspartic acid, valine, or serine substitution at codon 12, OR Aspartic acid or arginine substitution at codon 13 --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics - Endocrine therapy: No concurrent immunosuppressive drugs including systemic steroids or antiinflammatory drugs - Radiotherapy: No prior irradiation of spleen - Surgery: No prior splenectomy --Patient Characteristics-- - Age: Over 17 - Performance status: ECOG 0 or 1 - Life expectancy: Greater than 5 months - Hematopoietic: WBC at least 1,500/mm3; Platelet count at least 50,000/mm3 - Hepatic: Not specified - Renal: Not specified - Cardiovascular: No New York Heart Association class III or IV heart disease - Other: Not pregnant or nursing; Fertile patients must use effective contraception; No other medical condition that might prevent completion of study or prevent immunological response to study regimen; No other concurrent serious medical illness; No active bleeding
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StephenNimer, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067158; MSKCC-98037,NCI-G99-1542
Study Start Date: June 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003959
Other Previously Treated Myelodysplastic Syndrome Studies:
1. Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome
2. Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome
3. Immunosuppressive Therapy in Treating Patients With Myelodysplastic Syndrome
4. Infliximab in Treating Patients With Myelodysplastic Syndrome
5. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation or Isotretinoin in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Acute Lymphocytic Leukemia
Related Studies:
Other Previously Treated Myelodysplastic Syndrome Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome
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