Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
Biological: sargramostim Drug: dexamethasone Drug: oral sodium phenylbutyrate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Phenylbutyrate, Dexamethasone and GM-CSF in Refractory or Relapsed t(8;21) Acute Myeloid Leukemia |
| Study Start Date: | October 2000 |
| Study Completion Date: | August 2001 |
OBJECTIVES:
- 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.
- Determine the correlation between histone acetylation, differentiation, and apoptosis in bone marrow mononuclear cells with response rate in patients treated with this regimen.
- Determine the overall survival of patients on this regimen.
- Determine the correlation between histone acetylation, differentiation, and apoptosis in bone marrow mononuclear cells with pharmacokinetics of this regimen in these patients.
- Determine the safety and toxicity of this regimen in these patients.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Maryland | |
| National Heart, Lung, and Blood Institute | |
| Bethesda, Maryland, United States, 20892 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, New York | |
| Mount Sinai Medical Center, NY | |
| New York, New York, United States, 10029 | |
| United States, Pennsylvania | |
| University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15213-3489 | |
| Study Chair: | Johnson Liu, MD | National Heart, Lung, and Blood Institute (NHLBI) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006240 History of Changes |
| Other Study ID Numbers: | CDR0000068165, NHLBI-00-H-0156, NCI-171 |
| Study First Received: | September 11, 2000 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult acute myeloid leukemia |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Neoplasms by Histologic Type Neoplasms Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate 4-phenylbutyric acid BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013