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Recurrent Adult Acute Lymphoblastic LeukemiaPhase 1/2NCT00016016

Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia

A Phase 1/2 study testing cytarabine, mitoxantrone hydrochloride and alvocidib in people with Recurrent Adult Acute Lymphoblastic Leukemia and Recurrent Adult Acute Myeloid Leukemia, 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

Phase II trial to study the effectiveness of combining flavopiridol and cytarabine with mitoxantrone in treating patients who have acute leukemia. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
cytarabine, mitoxantrone hydrochloride and alvocidib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteUnited States
Study dates
Feb 2001to Nov 2006
Phase
Phase 1/2
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

  • Established diagnoses of poor-risk hematologic malignancies will be considered eligible for this Phase I/II study
  • Pathological confirmation of the diagnosis of AML or ALL
  • ECOG performance status 0,1,2
  • Patients must be able to give informed consent
  • Female patients of childbearing age must have negative pregnancy test
  • AST and ALT =< 2.5 x normal
Show all 19Show fewer
  • Alkaline phosphatase =< 2.5 x normal
  • Bilirubin =< 1.5 x normal
  • Serum creatinine =< 2.0 mg/dl
  • Left ventricular ejection fraction must >= 45% by MUGA or Echocardiogram
  • Acute Myelogenous Leukemia (AML)
  • AML arising from MDS
  • Secondary AML
  • Relapsed or refractory AML, including primary induction failure
  • Acute Lymphoblastic Leukemia (ALL)
  • Relapsed or refractory ALL, including primary induction failure
  • Patients who fail primary induction therapy or who relapse after achieving complete remission (CR) are eligible if they have undergone no more than 3 prior courses of induction/reinduction
  • There should be an interval of at least 4 weeks from any previous intensive chemotherapy before beginning flavopiridol, with the exceptions non-aplasia producing treatments (i.e. hydroxyurea, interferon, imatinib, 6MP, thalidomide); patients should have recovered completely from any treatment-related toxicities; patients may have received hematopoietic growth factors previously, but must be off all growth factors (including EPO, G-CSF, GM-CSF, IL-3, IL-11) for at least 4 days prior to beginning flavopiridol
  • Patients who have undergone stem cell transplantation (SCT), autologous or allogeneic, are eligible provided that they are >= 4 weeks from stem cell infusion, have no active GVHD, and meet other eligibility criteria

Who cannot join

  • Hyperleukocytosis with >= 50,000 leukemic blasts/mm^3
  • Active, uncontrolled infection
  • Disseminated intravascular coagulation
  • Active CNS leukemia
  • Concomitant chemotherapy, radiation therapy or immunotherapy
  • Intrinsic impaired cardiac function (MI within the preceding 3 months or history of severe coronary artery disease, cardiomyopathy, CHF > Class II)
  • History of congestive heart disease, or arrhythmia without regard to time, severity or resolution
  • Women who are pregnant or lactating will not be eligible for this trial, as the investigational agent may be harmful to the developing fetus or nursing infant

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21287-8936

Other trials in United States

About this study

Official title: A Phase I/II Study of Flavopiridol (NSC 649890, IND 46,211) in Timed Sequential Combination With Cytosine Arabinoside (Ara-C) and Mitoxantrone for Adults With Poor-Risk Acute Leukemias

Phase II trial to study the effectiveness of combining flavopiridol and cytarabine with mitoxantrone in treating patients who have acute leukemia. Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To determine the toxicities of escalating doses of flavopiridol administered in a timed sequence with ara-C and mitoxantrone in adults with refractory or relapsed acute leukemias or high-risk myelodysplasias (MDS).

II. To determine if flavopiridol administered in a timed sequence with ara-C and Mitoxantrone will induce clinical responses in adults with refractory or relapsed acute leukemias or MDS.

III. To determine if flavopiridol is directly cytotoxic to leukemic blasts in vivo.

IV. To determine if flavopiridol can recruit and synchronize residual leukemic blasts to proliferate in vivo.

OUTLINE: This is a dose-escalation study of flavopiridol. (Phase I closed to accrual effective10/24/2003).

Patients receive flavopiridol IV over 1 hour on days 1-3 and cytarabine IV continuously on days 6-9 followed by mitoxantrone IV over 30-150 minutes on day 9. Patients achieving a partial or complete response after the first course of therapy may receive an additional course of therapy beginning 35 ± 7 days after blood count recovery.

Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. (Phase I closed to accrual effective 10/24/2003). Once the MTD is reached, additional patients are accrued to receive flavopiridol at the recommended phase II dose.

Being tested
cytarabine, mitoxantrone hydrochloride, alvocidib, pharmacological study, laboratory procedure
Medical subject headings
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.

  • cytarabineDrug

    Given IV

  • mitoxantrone hydrochlorideDrug

    Given IV

  • alvocidibDrug

    Given IV

  • pharmacological studyOther

    Correlative studies

  • laboratory procedureOther

    Correlative studies

Study groups in NCT00016016
Study groupRoleWhat they receive
Treatment (flavopiridol, cytarabine, mitoxantrone)ExperimentalPatients receive flavopiridol IV over 1 hour on days 1-3 and cytarabine IV continuously on days 6-9 followed by mitoxantrone IV over 30-150 minutes on day 9. Patients achieving a partial or complete response after the first course of therapy may receive an additional course of therapy beginning 35 ± 7 days after blood count recovery.
Receives: Drug: cytarabine; Drug: mitoxantrone hydrochloride; Drug: alvocidib; Other: pharmacological study; Other: laboratory procedure

What is being measured

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

  1. Dose-limiting toxicity (DLT) as assessed by NCI CTC version 2.0

    Measured: Up to 35 days

  2. Complete remission (CR)

    Measured: Up to 6 years

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study startFeb 2001
  3. Primary completionNov 2006

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00016016
Sponsor's protocol ID
NCI-2012-03153
Other IDs
NCI-2012-03153, MSGCC-0052, NCI-3170, JHOC-J0254, J0254, 3170, U01CA070095, U01CA069854
Status last verified
Oct 2013
First submitted
6 May 2001
Last updated
8 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing cytarabine, mitoxantrone hydrochloride and alvocidib in people with Recurrent Adult Acute Lymphoblastic Leukemia and Recurrent Adult Acute Myeloid Leukemia, 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 19 inclusion and 8 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 8 Oct 2013. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Dose-limiting toxicity (DLT) as assessed by NCI CTC version 2.0 (time frame: Up to 35 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 NCT00016016.

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 8 Oct 2013.

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