|
Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia Clinical research trials and Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia. Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "P" Clinical Trials Conditions > Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia  Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
For Condition: recurrent adult acute myeloid leukemia
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining phenylbutyrate, dexamethasone, and sargramostim in treating patients who have refractory or relapsed acute myeloid leukemia.
Details: OBJECTIVES: I. Determine the objective response (complete hematologic remission induction) of phenylbutyrate, dexamethasone, and sargramostim (GM-CSF) in patients with refractory or relapsed t(8;21) acute myeloid leukemia. II. Determine the correlation between histone acetylation, differentiation, and apoptosis in bone marrow mononuclear cells with response rate in patients treated with this regimen. III. Determine the overall survival of patients on this regimen. IV. Determine the correlation between histone acetylation, differentiation, and apoptosis in bone marrow mononuclear cells with pharmacokinetics of this regimen in these patients. V. Determine the safety and toxicity of this regimen in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive phenylbutyrate IV continuously and sargramostim (GM-CSF) subcutaneously on days 1-7 and 15-21. Patients also receive oral dexamethasone on days 1-4 and 15-18. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity until complete hematologic remission is induced. Patients with stable disease at the end of 1 course receive at least 2 additional courses. Patients are followed twice a week for 3 months, monthly for 1 year, every three months for the next 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study in at least 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of t(8;21) acute myeloid leukemia (AML) - Failed standard induction chemotherapy or stem cell transplantation (SCT) OR - Relapsed after standard induction chemotherapy or SCT OR - Refused or not a candidate for SCT or matched allogeneic sibling bone marrow transplantation or donor lymphocyte infusion OR - Refused of not a candidate for autologous SCT or bone marrow transplantation No CNS leukemia --Prior/Concurrent Therapy-- Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 3 weeks since prior investigational antineoplastic drugs --Patient Characteristics-- Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 7 days Hematopoietic: Not specified Hepatic: - AST or ALT no greater than 3 times upper limit of normal (ULN) - Bilirubin no greater than 3 times ULN - No hepatic disease that would preclude study Renal: - Creatinine no greater than 2 mg/dL - Creatinine clearance at least 60 mL/min - No renal disease that would preclude study Cardiovascular: - No cardiac disease that would preclude study - No New York Heart Association class III or IV heart disease - No myocardial infarction within past 8 weeks Other: - No active infection except cystitis - Not pregnant or nursing - No altered mental status or seizure disorder - No other serious disease that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JohnsonLiu, Study Chair, National Heart, Lung, and Blood Institute (NHLBI)
Mount Sinai Medical Center, NY
New York City, New York, 10029
United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213-3489
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
National Heart, Lung, and Blood Institute
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: CDR0000068165; NCI-171,NHLBI-00-H-0156
Study Start Date: October 2000
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006240
Other Recurrent Adult Acute Myeloid Leukemia Studies:
1. DTGM Fusion Protein in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia
2. Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
3. Monoclonal Antibody in Treating Patients With Acute Myelogenous Leukemia
4. Chemotherapy Followed by Donor White Blood Cells Plus Interleukin-2 in Treating Patients With Acute Myeloid or Lymphocytic Leukemia
5. FR901228 in Treating Patients With Hematologic Cancer
Related Studies:
Other recurrent adult acute myeloid leukemia Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
|
|
|
|
|
|
|
|
