NCT00459212

Brief Summary

This phase I trial is studying the side effects and best dose of GTI-2040 in treating patients with relapsed, refractory, or high-risk acute leukemia, high-grade myelodysplastic syndromes, or refractory or blastic phase chronic myelogenous leukemia. Drugs used in chemotherapy, such as GTI-2040, work in different ways to stop the growth of cancer or abnormal cells, either by killing the cells or by stopping them from dividing.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Last Updated

December 4, 2015

Status Verified

April 1, 2013

Enrollment Period

3.8 years

First QC Date

April 9, 2007

Last Update Submit

December 3, 2015

Conditions

Acute Undifferentiated LeukemiaAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Blastic Phase Chronic Myelogenous Leukemiade Novo Myelodysplastic SyndromesPreviously Treated Myelodysplastic SyndromesRecurrent Adult Acute Lymphoblastic LeukemiaRecurrent Adult Acute Myeloid LeukemiaRelapsing Chronic Myelogenous LeukemiaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesUntreated Adult Acute Lymphoblastic LeukemiaUntreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (2)

  • Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)

    28 days

  • Change in dCTP levels in PBMC and bone marrow by Real-Time PCR

    Days 1, 4, 15, and 19 of course 1

Secondary Outcomes (7)

  • Objective tumor response

    Up to 3 years

  • Overall survival

    Up to 3 years

  • Time to failure

    Up to 3 years

  • Duration of response

    Up to 3 years

  • Change in expression levels of R1, R2, and p53R2 mRNA in PBMC by Real-Time PCR

    Day 1, 4, 15, and 19 of course 1

  • +2 more secondary outcomes

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive GTI-2040 IV continuously on days 1-4 and 15-18.

Drug: GTI-2040Procedure: pharmacological studyProcedure: laboratory biomarker analysis

Interventions

GTI-2040DRUG

Given IV

Arm I
pharmacological studyPROCEDURE

Correlative study

Also known as: pharmacological studies
Arm I
laboratory biomarker analysisPROCEDURE

Correlative study

Arm I

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of 1 of the following:
  • Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) refractory to primary standard induction therapy
  • Relapsed or refractory acute leukemia
  • Chronic myelogenous leukemia (CML) in blast crisis at diagnosis OR that failed prior aggressive induction chemotherapy
  • Diagnosis of 1 of the following:
  • Acute leukemia secondary to preexisting hematologic condition or prior chemotherapy at diagnosis OR that failed prior aggressive induction chemotherapy
  • Advanced myelodysplastic syndromes (intermediate-1 or greater)
  • De novo acute leukemia (myeloid or nonmyeloid)
  • Not a candidate for aggressive standard induction chemotherapy
  • De novo AML or ALL (patients \> 60 years of age)
  • No suspected or proven active CNS leukemia
  • ECOG performance status (PS) 0-2 OR Karnofsky PS 50-100%
  • Life expectancy \>= 8 weeks
  • Bilirubin =\< 1.5 mg/dL
  • AST and ALT \< 3 times upper limit of normal (ULN)
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Leukemia, Biphenotypic, AcuteCongenital AbnormalitiesBlast CrisisPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, Acute

Interventions

GTI2040

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mark Kirschbaum

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2007

First Posted

April 11, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2010

Last Updated

December 4, 2015

Record last verified: 2013-04

Locations

US(1)