NCT00006239

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Tretinoin may help hematologic cancer cells develop into normal white blood cells. PURPOSE: Phase I trial to study the effectiveness of combining phenylbutyrate and tretinoin in treating patients who have hematologic cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Dec 2000

Geographic Reach
1 country

1 active site

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
3 months until next milestone

Study Start

First participant enrolled

December 1, 2000

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
Last Updated

September 29, 2017

Status Verified

September 1, 2017

Enrollment Period

4.2 years

First QC Date

September 11, 2000

Last Update Submit

September 27, 2017

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Diseases

Keywords

recurrent adult acute myeloid leukemiauntreated adult acute myeloid leukemiarefractory anemiarefractory anemia with ringed sideroblastsrefractory anemia with excess blastsrefractory anemia with excess blasts in transformationchronic myelomonocytic leukemiapreviously treated myelodysplastic syndromesatypical chronic myeloid leukemiamyelodysplastic/myeloproliferative disease, unclassifiableadult acute myeloid leukemia with t(8;21)(q22;q22)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with t(15;17)(q22;q12)

Interventions

sodium phenylbutyrateDRUG
tretinoinDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed myelodysplastic syndrome (MDS) * Refractory anemia * Primary refractory leukopenia or thrombocytopenia with morphologic features of MDS * Refractory anemia with excess blasts (RAEB) * Refractory anemia with ringed sideroblasts * RAEB in transformation * Must have excess blasts or be hematopoietically compromised, defined as one of the following: * RBC transfusion dependent * Granulocyte count less than 1,000/mm\^3 * Platelet count less than 50,000/mm\^3 OR * Diagnosis of chronic myelomonocytic leukemia * Hematopoietically compromised (as defined above) OR * Excess blasts OR * Evaluable disease related symptomatology (organomegaly or leukemia cutis) OR * Diagnosis of acute myeloid leukemia * WBC less than 20,000/mm\^3 and stable for at least 2 weeks * Unlikely to require cytotoxic therapy during study * No CNS or pulmonary leukostasis or CNS leukemia PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0-2 Life expectancy: * Not specified Hematopoietic: * See Disease Characteristics * Hemoglobin at least 8 g/dL (transfusion allowed) * No disseminated intravascular coagulation Hepatic: * Bilirubin less than 2.0 mg/dL (unless due to hemolysis or Gilbert's syndrome) Renal: * Creatinine less than 2.0 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 2 weeks prior, during, and for 3 months after study * No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * At least 3 weeks since prior biologic therapy, including hematopoietic growth factors, and recovered Chemotherapy: * See Disease Characteristics * At least 3 weeks (1 month for MDS patients) since prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * At least 3 weeks since prior radiotherapy and recovered Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Myeloid, AcuteAnemia, RefractoryAnemia, Refractory, with Excess of BlastsLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative DisordersCongenital Abnormalities

Interventions

4-phenylbutyric acidTretinoin

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, MyeloidAnemiaChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Vitamin ARetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Steven D. Gore, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

December 1, 2000

Primary Completion

February 1, 2005

Study Completion

March 1, 2005

Last Updated

September 29, 2017

Record last verified: 2017-09

Locations

US(1)