ClinicalTrials.gg
Sign In
CompletedNCT00462787Updated Nov 14, 2013

Combination Chemotherapy in Treating Young Patients With Relapsed or Refractory Acute Leukemia

A Phase 1 interventional study of filgrastim and clofarabine in Leukemia, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 1 site in United States. Open to participants aged Up to 28 Years. Per ClinicalTrials.gov, last updated 2013-11-14.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
Up to 28 Years
Sex
All
01

Study summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine, topotecan, vinorelbine, thiotepa, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine when given together with topotecan, vinorelbine, thiotepa, and dexamethasone in treating young patients with relapsed or refractory acute leukemia.

Read the detailed description

OBJECTIVES:

  • Determine the maximum tolerated dose of clofarabine when administered in combination with topotecan hydrochloride, vinorelbine ditartrate, thiotepa, and dexamethasone in young patients with relapsed or refractory acute leukemia.
  • Evaluate the antileukemic potential of this regimen in these patients.
  • Evaluate the incidence and severity of treatment-related morbidity and mortality in patients treated with this regimen.
  • Develop a new reinduction treatment regimen that will result in a patient clinical response with as little residual disease as possible to permit a bone marrow transplantation while in subsequent remission; maintain the response long enough to identify an appropriate stem cell donor; and permit the patient to undergo a stem cell transplantation free of infections and without vital organ dysfunction.

OUTLINE: This is a nonrandomized, prospective, dose-escalation study of clofarabine.

Patients receive topotecan hydrochloride IV continuously over 120 hours on days 0-4; vinorelbine ditartrate over 6-10 minutes on days 0, 7, and 14; thiotepa IV over 4 hours on day 2; clofarabine IV over 2 hours on days 3-7; and oral or IV dexamethasone 3 times daily on days 3 and 7-13 and then on day 3 only thereafter. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 8 and continuing until blood counts recover. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of clofarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity OR the dose preceding that at which 2 of 3 patients experience dose-limiting toxicity. At least 6 patients are treated at the MTD.

After completion of study treatment, patients are followed once a week for 4 weeks, twice a month for 6 months, and then once a month for 2 years.

PROJECTED ACCRUAL: A total of 23 patients will be accrued for this study.

02

Conditions studied

  • Leukemia

Keywords

  • acute undifferentiated leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • recurrent adult acute myeloid leukemia
03

In context

Leukemia

5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.

This study's enrollment of 23 is below the median of 38 across 4,268 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,957 studies on the registry; 323 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 68 (52%) have results posted.

Browse Memorial Sloan Kettering Cancer Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 28 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

  • Must have 1 of the following diagnoses:

    • Acute lymphoblastic leukemia (ALL) meeting 1 of the following criteria:

      • Refractory to initial induction with two or more standard regimens
      • Relapsed \< 24 months after first complete response on a high-risk protocol OR refractory to one standard reinduction regimen
      • Second or greater relapse

    • Acute myeloid leukemia, acute biphenotypic leukemia, or acute undifferentiated leukemia meeting 1 of the following criteria:

      • Refractory to initial induction
      • First or greater relapse
  • Must have > 20% bone marrow blasts, or evidence of recurrent disease at an extramedullary site

  • No symptomatic CNS disease

    • Patients with asymptomatic CNS disease are eligible with the approval of the principal investigator

PATIENT CHARACTERISTICS:

  • Karnofsky performance status (PS) 70-100% OR Lansky PS 70-100%
  • AST and ALT \< 4 times upper limit of normal
  • Bilirubin \< 2.0 mg/dL (unless liver involvement)
  • Creatinine within normal range for age OR creatinine clearance > 60 mL/min/1.73 m\^2
  • Adequate cardiac function (either asymptomatic with no prior risk factors, or if symptomatic, left ventricular ejection fraction > 50% at rest)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active uncontrolled viral, bacterial, or fungal infection

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior clofarabine

  • More than 2 weeks since prior systemic chemotherapy

    • At least 7 days since prior chemotherapy for patients with rapidly progressive disease and recovered
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    Clofarabine

    This is a single arm phase I clinical trial to assess safety (morbidity and mortality) of a novel leukemia re-induction regimen. The first component of this trial is a phase I dose escalation study to determine the maximum tolerated dose (MTD) of the novel agent Clofarabine, when used in combination with topotecan, vinorelbine, thiotepa and dexamethasone. A total of three dose levels will be explored in this study.

    Biological: filgrastim · Drug: clofarabine · Drug: dexamethasone · Drug: thiotepa · Drug: topotecan hydrochloride · Drug: vinorelbine tartrate

06

What researchers measure

Primary outcomes

  1. Maximum tolerated dose of clofarabine

    Time frame: 2 years

  2. Overall survival

    Time frame: 2 years

  3. Progression-free survival

    Time frame: 2 years

07

Study locations

1 site
  • Memorial Sloan-Kettering Cancer Center
    New York, New York 10065, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2007, a primary completion of Nov 2013 and a completion of Nov 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 18, 2007
First posted
Apr 19, 2007
Start
Apr 2007
Primary completionActual
Nov 2013
CompletionActual
Nov 2013
Last update
Nov 14, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 14, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00462787
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 19, 2007
Start date
Apr 2007
Primary completion
Nov 2013
Completion
Nov 2013
Last update
Nov 14, 2013

Study contacts

Peter G. Steinherz, MD
principal investigator · Memorial Sloan Kettering Cancer Center
Neerav Shukla, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Clofarabine · Dexamethasone · Thiotepa · Topotecan · Vinorelbine

Other studies in this condition

Leukemia →

Other studies from this sponsor

Memorial Sloan Kettering Cancer Center →

Start the discussion