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Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Clinical research trials and Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome. Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome clinical trial. Test subjects typically receive the most expert healthcare available for their Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome  Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
For Condition: adult acute myeloid leukemia,myelodysplastic and myeloproliferative disease,Chronic Myelomonocytic Leukemia,atypical chronic myeloid leukemia,Myelodysplastic Syndromes
Status: No longer recruiting
Sponsor(s): Sidney Kimmel Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Azacitidine plus phenylbutyrate may help leukemia cells develop into normal white blood cells. PURPOSE: Phase I trial to study the effectiveness of combining azacitidine and phenylbutyrate in treating patients who have acute myeloid leukemia or myelodysplastic syndrome.
Details: OBJECTIVES: - Determine the safety and toxicity of azacitidine in combination with phenylbutyrate in patients with recurrent, refractory, or untreated acute myeloid leukemia or myelodysplastic syndrome. - Determine the minimal effective pharmacologic dose of azacitidine required to consistently inhibit DNA methyltransferase in this patient population. - Obtain preliminary clinical and/or laboratory data suggesting potential therapeutic activity of this combination regimen in these patients. OUTLINE: This is a dose deescalation study of azacitidine. Patients receive azacitidine subcutaneously daily on days 1-5 and 29-33 followed by phenylbutyrate IV continuously on days 5-12 and 33-40. Treatment continues for at least 2 courses in the absence of disease progression. Patients with responsive disease may receive an additional 2 months of therapy. Cohorts of 3-6 patients receive deescalating doses of azacitidine until the minimal effective pharmacologic dose (MEPD) is determined. The MEPD is defined as the dose above the dose at which more than 1 of 6 patients do not meet the target enzyme inhibition of greater than 90%. Once the MEPD and toxicity have been established for a 5 day schedule, daily dose schedule of azacitidine is increased to 10, 14, and 21 days, followed by phenylbutyrate for 7 days. Courses are repeated every 28 days. PROJECTED ACCRUAL: Approximately 32 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed myelodysplastic syndrome (MDS) indicating one of the following: - Refractory anemia (RA) - Primary refractory leukopenia or thrombocytopenia with MDS morphology - RA with excess blasts (RAEB) - RA with ringed sideroblasts (RARS) - Chronic myelomonocytic leukemia - RAEB in transformation - RA or RARS must have at least one of the following: - Absolute neutrophil count less than 1,000/mm^3 - Untransfused hemoglobin less than 8 g/dL - Platelet count less than 20,000/mm^3 - Anemia - Thrombocytopenia requiring transfusion - High risk chromosomal abnormalities - Any stage of MDS allowed including: - Previously untreated MDS - Refractory MDS allowed if failure to achieve remission following prior intensive chemotherapy of at least 1 month ago - Relapsed, refractory, or untreated acute myeloid leukemia (AML) with the following: - WBC less than 30,000/mm^3 - Stable for at least 2 weeks - Unlikely to require cytotoxic therapy during study - Untreated AML with poor risk factors for response to standard therapy including: - Greater than 60 years old - AML occurs in setting of antecedent hematologic disorder - High risk chromosomes (e.g., abnormalities of chromosome 5 or 7 or complex cytogenetic abnormalities) - Medical conditions that preclude cytotoxic chemotherapy as primary therapy - Refusal of cytotoxic chemotherapy allowed - No clinical evidence of CNS leukostasis or CNS leukemia PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic: - Bilirubin less than 2.0 mg/dL (unless due to hemolysis or Gilbert's disease) Renal: - Creatinine less than 2.0 mg/dL Cardiovascular: - No disseminated intravascular coagulation Pulmonary: - No pulmonary leukostasis Other: - No active infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception 2 weeks prior, during and 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior biologic therapy including colony stimulating factors and recovered Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy and recovered Endocrine therapy: - At least 3 weeks since prior hormonal therapy and recovered Radiotherapy: - At least 3 weeks since prior radiotherapy and recovered Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenGore, Study Chair, Sidney Kimmel Cancer Center
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Additional Information:
Study ID Numbers: CDR0000067531; JHOC-99072307,NCI-T99-0092
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004871
Other Myelodysplastic And Myeloproliferative Disease Studies:
1. Doxercalciferol in Treating Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
2. Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
3. Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
4. Bone Marrow Transplantation Plus Cyclophosphamide and Radiation Therapy in Treating Patients With Hematologic Cancer
5. Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Related Studies:
Other myelodysplastic and myeloproliferative disease Clinical Trials
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Other Baltimore Clinical Trials
Azacitidine Plus Phenylbutyrate in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
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