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AzTrials

LeukemiaPhase 1NCT00004056

Combination Chemotherapy Followed by Melphalan and Peripheral Stem Cell Transplantation in Treating Children With Newly Diagnosed Acute Myeloid Leukemia

A Phase 1 study testing filgrastim, asparaginase and cytarabine in people with Leukemia, run by Children's Oncology Group at 20 sites in 2 countries.

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

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Leukemia
What is being tested?
filgrastim, asparaginase and cytarabine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
20 sitesin 2 countries
Study dates
Oct 1999to Mar 2007
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 Up to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS: Histologically proven, previously untreated primary acute myeloid leukemia (AML) Isolated granulocytic sarcoma (myeloblastoma) allowed Patients with cytopenias and bone marrow blasts greater than 5% but less than 30% eligible only if there is karyotypic abnormality characteristic of de novo AML (t(8;21), inv16, t(9;11), etc.) OR unequivocal presence of megakaryoblasts No acute promyelocytic leukemia (M3) No Down syndrome

PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Uric acid no greater than 8.0 mg/dL Cardiovascular: Cardiac function normal by echocardiogram Pulmonary: No uncontrolled, life threatening pneumonia Other: No uncontrolled, life threatening sepsis or meningitis Not pregnant Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: No prior therapy

Trial locations and contacts

20 sites in 2 countries.

20 sites in 2 countries

United States19 sites

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21231

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Children's Memorial Hospital, Chicago

    Chicago, Illinois, 60614

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Tomorrows Children's Institute

    Hackensack, New Jersey, 07601

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, California, 94304

  • Children's Hospital and Health Center

    San Diego, California, 92123-4282

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • Arizona Cancer Center

    Tucson, Arizona, 85724

Other trials in United States

Canada1 site

  • Montreal Children's Hospital

    Montreal, Quebec, H3H 1P3

Other trials in Canada

About this study

Official title: Treatment of Newly Diagnosed Childhood AML Using a Timed-Sequential Remission Induction and Consolidation Followed by Single Dose Melphalan With Peripheral Stem Cell Rescue: A POG Pilot Study

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy followed by melphalan and peripheral stem cell transplantation in treating children who have newly diagnosed acute myeloid leukemia that has not been treated previously.

Read the detailed description

OBJECTIVES: I. Determine the feasibility and toxicity of timed sequential remission induction and consolidation in children with newly diagnosed acute myeloid leukemia. II. Determine the feasibility and toxicity of a single high dose of melphalan with peripheral blood stem cell rescue following an intense timed sequential induction and consolidation in these children.

OUTLINE: This is a multicenter study. Remission induction: Patients receive daunorubicin IV over 15 minutes on days 1-3, cytarabine IV continuously on days 1-7, oral thioguanine daily on days 1-7, and cytarabine intrathecally (IT) on day 1. Cytarabine IV over 3 hours is administered every 12 hours on days 10-12. Filgrastim (G-CSF) is administered IV or subcutaneously (SQ) beginning on day 13 and continuing until blood counts recover. On approximately day 28, patients undergo a bone marrow aspirate and biopsy to assess response. Patients who have attained an M1 or M2a status proceed to consolidation or, if a 5/5 or 6/6 HLA matched sibling donor is available, proceed to allogeneic bone marrow transplantation. Patients with greater than 25% blasts go off study. Consolidation 1: Patients receive daunorubicin IV over 15 minutes on days 1 and 2, cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9, and asparaginase on days 2 and 9. G-CSF IV or SQ begins on day 10 and continues until blood counts recover. Consolidation 2: Patients receive cytarabine IV over 3 hours every 12 hours on days 1, 3, and 5. G-CSF IV or SQ begins on day 6 and continues until blood counts recover. Peripheral blood stem cells (PBSC) are collected after the second course of consolidation. Consolidation 3: Treatment is repeated as in consolidation 1. Patients who remain in morphologic remission after consolidation 3 proceed with therapy. Patients receive melphalan IV over 30 minutes on day -2, then PBSC are reinfused on day 0. G-CSF IV or SQ begins on day 1 and continues until blood counts recover. Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 8 months.

Conditions
Leukemia
Being tested
filgrastim, asparaginase, cytarabine, daunorubicin hydrochloride, melphalan
Keywords
untreated childhood acute myeloid leukemia and other myeloid malignancies, childhood acute monoblastic leukemia and acute monocytic leukemia (M5), childhood acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia with maturation (M2), childhood acute myelomonocytic leukemia (M4), childhood acute erythroleukemia (M6), childhood acute megakaryocytic leukemia (M7), childhood acute minimally differentiated myeloid leukemia (M0)
Medical subject headings
Leukemia, Leukemia, Monocytic, Acute

What participants receive

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

  • filgrastimBiological

    Also called Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, GCSF, Neupogen®

  • asparaginaseDrug

    Also called E. coli, Elspar, NSC #109229

  • cytarabineDrug

    Also called cytosine arabinoside, AraC, Cytosar, NSC #063878

  • daunorubicin hydrochlorideDrug

    Also called daunomycin, DNR, Cerubidine, NSC #82151

  • melphalanDrug

    Also called L-phenylalanine mustard, L-PAM, L-sarcolysin, Alkeran

  • thioguanineDrug

    Also called 6-thioguanine, 6-TG, NSC #000752

  • peripheral blood stem cell transplantationProcedure or surgery

Study groups in NCT00004056
Study groupRoleWhat they receive
Chemo + STEM cellExperimentalSee detailed description.
Receives: Biological: filgrastim; Drug: asparaginase; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: melphalan; Drug: thioguanine; Procedure: peripheral blood stem cell transplantation

What is being measured

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

  1. Feasibility and toxicity of an intensive regimen that uses timed-sequential therapy

    To determine the feasibility and toxicity of an intensive regimen that uses timed-sequential therapy as a strategy for both remission induction and consolidation of newly diagnosed children with AML.

    Measured: Length of study

  2. Feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue

    To test the feasibility and toxicity of a single high dose of melphalan with peripheral stem cell rescue following an intense timed-sequential induction and consolidation.

    Measured: Length of study

Secondary outcomes (1)

  1. Make observations regarding PCR evidence of Minimal Residual Disease

    To make observations regarding PCR evidence of Minimal Residual Disease in patients with relevant specific translocations who obtain a clinical remission.

    Measured: Length of study

Timeline

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

  1. First posted20 May 2004 (estimated)
  2. Study startOct 1999
  3. Primary completionOct 2002
  4. Study completionMar 2007

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
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004056
Sponsor's protocol ID
9822
Other IDs
POG-9822, CDR0000067253
Status last verified
Jul 2014
First submitted
10 Dec 1999
Last updated
28 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Hurwitz CA, Chang M, Graham M, et al.: Timed-sequential remission induction and intensification followed by stem cell rescue for childhood AML -a POG pilot study. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1553, 2002.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing filgrastim, asparaginase and cytarabine in people with Leukemia, run by Children's Oncology Group at 20 sites in 2 countries.

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

Who may be eligible to take part?

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 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada. 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?

Feasibility and toxicity of an intensive regimen that uses timed-sequential therapy (time frame: Length of study). 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 NCT00004056, which also lists 1 linked publication.

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 28 Jul 2014.

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