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Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer Clinical research trials and Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer. Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer  Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer
Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer
For Condition: Leukemia,Lymphoma,Lung Cancer,Prostate Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of phenylbutyrate plus azacitidine in treating patients who have acute myeloid leukemia, myelodysplasia, non-Hodgkin's lymphoma, multiple myeloma, non-small cell lung cancer, or prostate cancer.
Details: OBJECTIVES: I. Determine the ability of azacytidine in vivo to demethylate selected genes known to be transcriptionally repressed in patients with acute myeloid leukemia, myelodysplasia, non-Hodgkin's lymphoma, multiple myeloma, non-small cell lung cancer, or prostate cancer. II. Determine the ability of phenylbutyrate plus azacytidine to induce transcription of target genes that are known to be repressed as a consequence of DNA methylation in these patients. III. Determine the effect of this treatment regimen upon gene methylation and histone acetylation in target cells in these patients. IV. Determine the technical feasibility of serially monitoring transcriptional activity and methylation status of selected genes in vivo in these patients. V. Determine the safety and potential antitumor efficacy of this treatment regimen in these patients. PROTOCOL OUTLINE: Patients receive azacytidine subcutaneously on days 1-7 and phenylbutyrate IV over 1-2 hours on days 8-12. Patients with acute myeloid leukemia who respond to therapy may receive a second course approximately 10 days after the end of the first. Subsequent courses in these patients, and all additional courses in all other patients, are repeated every 21 to 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of one of the following neoplastic diseases: Acute myeloid leukemia; Myelodysplasia; Low or intermediate grade non-Hodgkin's lymphoma; Multiple myeloma; Non-small cell lung cancer; Prostate cancer - Failed prior conventional therapy and no other known curative therapy exists - Patients with non-Hodgkin's lymphoma, non-small cell lung cancer, and prostate cancer must have tumor cells in bone marrow or malignant effusions that are accessible for bone marrow aspiration or paracentesis/thoracentesis [Note: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology.] --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Patients without leukemia: At least 3 weeks since prior cytotoxic chemotherapy - Endocrine therapy: Not specified - Radiotherapy: Patients without leukemia: At least 3 weeks since prior radiotherapy - Surgery: Not specified --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Patients without leukemia or myeloma: WBC at least 2,500/mm3; Platelet count at least 75,000/mm3 - Hepatic: Bilirubin no greater than 2.5 mg/dL - Renal: Creatinine no greater than 2.5 mg/dL - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 4 weeks after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PeterMaslak, 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: CDR0000068030; NCI-T99-0091,MSKCC-99060
Study Start Date: March 2001
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006019
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2. Evaluation, Treatment, and Natural History of Children with Cancer
3. Chemotherapy, Radiation Therapy, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
4. Fludarabine, Carboplatin, and Topotecan in Treating Patients With Relapsed or Refractory Acute Leukemia or Advanced Myelodysplastic Syndrome
5. Prevention of Graft-Versus-Host Disease in Patients Undergoing Bone Marrow Transplantation
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Phenylbutyrate Plus Azacitidine in Treating Patients With Acute Myeloid Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Multiple Myeloma, Non-small Cell Lung Cancer, or Prostate Cancer
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