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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006019 |
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.
Condition | Intervention | Phase |
Leukemia Lung Cancer Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Prostate Cancer |
Drug: azacitidine Drug: sodium phenylbutyrate |
Phase II |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lung Cancer Lymphoma Multiple Myeloma Prostate Cancer |
ChemIDplus related topics: | Azacitidine Sodium phenylbutyrate |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Pilot Study of Sodium Phenylbutyrate Plus Azacytidine |
Study Start Date: | May 2000 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following neoplastic diseases:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Patients without leukemia or myeloma:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Patients without leukemia:
Endocrine therapy:
Radiotherapy:
Patients without leukemia:
Surgery:
United States, New York | |||||
Memorial Sloan-Kettering Cancer Center | |||||
New York, New York, United States, 10021 |
Memorial Sloan-Kettering Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Peter Maslak, MD | Memorial Sloan-Kettering Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000068030, MSKCC-99060, NCI-T99-0091 |
First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006019 |
Health Authority: | United States: Federal Government |
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