Leukemia Clinical Trial
Official title:
A Pilot Study of Phenylbutyrate, Dexamethasone and GM-CSF in Refractory or Relapsed t(8;21) Acute Myeloid Leukemia
Verified date | November 2002 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | August 2001 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 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 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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Heart, Lung, and Blood Institute | Bethesda | Maryland |
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland |
United States | Mount Sinai Medical Center, NY | New York | New York |
United States | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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