Phenylbutyrate, Dexamethasone, and Sargramostim in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia

• Status: Completed
• Trial end date: 2001-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: 4-phenylbutyric acid; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Sargramostim

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

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