NCT00006240

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2000

Shorter than P25 for phase_2 leukemia

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2000

Completed
20 days until next milestone

Study Start

First participant enrolled

October 1, 2000

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
2 years until next milestone

First Posted

Study publicly available on registry

July 28, 2003

Completed
Last Updated

April 28, 2015

Status Verified

November 1, 2002

First QC Date

September 11, 2000

Last Update Submit

April 27, 2015

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia

Interventions

sargramostimBIOLOGICAL
dexamethasoneDRUG
oral sodium phenylbutyrateDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

National Heart, Lung, and Blood Institute

Bethesda, Maryland, 20892, United States

Location

Mount Sinai Medical Center, NY

New York, New York, 10029, United States

Location

University of Pittsburgh Cancer Institute

Pittsburgh, Pennsylvania, 15213-3489, United States

Location

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Acute

Interventions

sargramostimDexamethasone4-phenylbutyric acid

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, Myeloid

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Johnson Liu, MD

    National Heart, Lung, and Blood Institute (NHLBI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 11, 2000

First Posted

July 28, 2003

Study Start

October 1, 2000

Study Completion

August 1, 2001

Last Updated

April 28, 2015

Record last verified: 2002-11

Locations

US(4)