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Acute Undifferentiated LeukemiaPhase 1NCT00459212

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

A Phase 1 study testing GTI-2040, pharmacological study and laboratory biomarker analysis in people with Acute Undifferentiated Leukemia and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, run by National Cancer Institute (NCI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GTI-2040, pharmacological study and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
Mar 2007to Dec 2010
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 36Show fewer
  • 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)
  • Creatinine =< 1.5 times ULN
  • No HIV positivity
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to other phosphorothiolated oligonucleotides
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Ongoing, active, or poorly controlled infection
  • Symptomatic congestive heart failure
  • Unstable angina pectoris
  • No uncontrolled intercurrent illness including, but not limited to, any of the following:
  • Cardiac arrhythmia
  • Poorly controlled pulmonary disease
  • Psychiatric illness or social situation that would preclude study compliance
  • Recovered from all prior therapies
  • Prior autologous or allogeneic stem cell transplantation allowed (No active graft-vs-host disease > grade 2)
  • At least 2 weeks since prior and no concurrent cytotoxic chemotherapy
  • At least 2 weeks since prior and no concurrent biologic therapy
  • At least 2 weeks since any other prior investigational agent
  • No other concurrent anticancer therapy, including radiotherapy or hormonal therapy
  • Concurrent imatinib mesylate for CML allowed
  • Not pregnant or nursing
  • Negative pregancy test

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Phase I and Pharmacodynamic Study of GTI-2040 (NSC 722929, IND 67368) in Acute Leukemias

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.

Read the detailed description

OBJECTIVES:

  1. Determine the maximum tolerated dose of GTI-2040 in patients with relapsed, refractory, or high-risk acute leukemia, high-grade myelodysplastic syndromes, or refractory or blastic phase chronic myelogenous leukemia.

II. Assess the toxicity and efficacy of this drug in these patients. III. Assess plasma and intracellular pharmacokinetics of this drug in these patients.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive GTI-2040 IV continuously on days 1-4 and 15-18. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of GTI-2040 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Blood samples are collected on days 1, 4, 15, and 19 of course 1 for pharmacokinetic studies. Samples are analyzed by proteomic assay, dCTP pool measurement, and real-time polymerase chain reaction for mRNA of RRM2, RRM1, and p53R2.

Being tested
GTI-2040, pharmacological study, laboratory biomarker analysis
Medical subject headings
Leukemia, Biphenotypic, Acute, Congenital Abnormalities, Blast Crisis, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GTI-2040Drug

    Given IV

  • pharmacological studyProcedure or surgery

    Also called pharmacological studies

    Correlative study

  • laboratory biomarker analysisProcedure or surgery

    Correlative study

Study groups in NCT00459212
Study groupRoleWhat they receive
Arm IExperimentalPatients receive GTI-2040 IV continuously on days 1-4 and 15-18.
Receives: Drug: GTI-2040; Procedure: pharmacological study; Procedure: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 28 days

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

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

Secondary outcomes (7)

  1. Objective tumor response

    Measured: Up to 3 years

  2. Overall survival

    Measured: Up to 3 years

  3. Time to failure

    Measured: Up to 3 years

  4. Duration of response

    Measured: Up to 3 years

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

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

  6. Change in intracellular levels of GTI-2040 by ELISA

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

  7. Incidence of grade 3 or higher toxicity assessed by CTCAE v3.0

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionDec 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00459212
Sponsor's protocol ID
NCI-2009-00206
Other IDs
PHI-57, CDR0000539257, U01CA062505
Status last verified
Apr 2013
First submitted
9 Apr 2007
Last updated
4 Dec 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GTI-2040, pharmacological study and laboratory biomarker analysis in people with Acute Undifferentiated Leukemia and Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 36 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00459212.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.

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