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LeukemiaPhase 1NCT00009698

Interleukin-2 in Treating Children Who Have Undergone Bone Marrow Transplantation for Acute Myeloid Leukemia

A Phase 1 study testing aldesleukin in people with Leukemia, run by Children's Oncology Group at 119 sites in 6 countries.

Completed

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

Official record
Search all trials

Trial summary

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating children who have undergone bone marrow transplantation for acute myeloid leukemia. Read more about this study

Who is it for?
Ages Up to 21 years
Conditions the study is for
Leukemia
What is being tested?
aldesleukin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
119 sitesin 6 countries
Study dates
Mar 1998to Sep 2005
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: Diagnosis of acute myeloid leukemia (AML) Must have received autologous bone marrow or stem cell transplantation for AML within the past 28 to 100 days Evidence of marrow engraftment Absolute neutrophil count at least 500/mm3 for at least 2 consecutive days Platelet count at least 20,000/mm3 without transfusion support for more than 3 days Documented M1 or M2 bone marrow within the past 7 days

PATIENT CHARACTERISTICS: Age: Under 22 at diagnosis Performance status: Karnofsky 50-100% Life expectancy: At least 8 weeks Hematopoietic: See Disease Characteristics Hepatic: Bilirubin no greater than 1.5 mg/dL SGPT no greater than 2 times normal Renal: Creatinine normal OR Glomerular filtration rate at least 70 mL/min Cardiovascular: Shortening fraction at least 27% OR Ejection fraction greater than 50% No evidence of active cardiac disease by electrocardiogram Pulmonary: No evidence of active pulmonary disease by chest x-ray Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Neurologic deficits due to CNS disease must be stable within the past 4 weeks No active viral, bacterial, or invasive fungal infection No fever No prior hypersensitivity to interleukin-2 No greater than grade 2 mucosal toxicity

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 3 days since prior growth factors or intravenous immunoglobulin No concurrent cytokines or growth factors No concurrent intravenous immunoglobulin Chemotherapy: No concurrent chemotherapy No concurrent methotrexate IV or intrathecally Endocrine therapy: At least 3 days since prior corticosteroids No concurrent corticosteroids (except as premedication for documented severe transfusion reactions) Radiotherapy: Not specified Surgery: Not specified Other: At least 3 days since prior pentoxifylline or amphotericin B No concurrent pentoxifylline No other concurrent anticancer therapy

Trial locations and contacts

119 sites in 6 countries.

119 sites in 6 countries

United States104 sites

  • University of New Mexico School of Medicine

    Albuquerque, New Mexico, 87131

  • Mission Saint Joseph's Health System

    Asheville, North Carolina, 28801

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35294-3300

  • Boston Floating Hospital Infants and Children

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center

    Burlington, Vermont, 05401-3498

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • West Virginia University Medical School-Charleston

    Charleston, West Virginia, 25304

  • Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Healthcare

    Charlotte, North Carolina, 28233-3549

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • Rush-Presbyterian-St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Children's Memorial Hospital, Chicago

    Chicago, Illinois, 60614

  • University of Missouri-Columbia Hospital and Clinics

    Columbia, Missouri, 65212

  • Driscoll Children's Hospital

    Corpus Christi, Texas, 78466

  • Texas Oncology P.A.

    Dallas, Texas, 75230-2503

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • St. John's Hospital and Medical Center

    Detroit, Michigan, 48236

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • Shands Hospital and Clinics, University of Florida

    Gainesville, Florida, 32610-100277

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0209

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-3508

  • East Carolina University School of Medicine

    Greenville, North Carolina, 27858-4354

  • Children's Hospital of Greenville Hospital System

    Greenville, South Carolina, 29605

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • James H. Quillen College of Medicine

    Johnson City, Tennessee, 37614-0622

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • Keesler Medical Center - Keesler AFB

    Keesler Air Force Base, Mississippi, 39534-2576

  • University of California San Diego Cancer Center

    La Jolla, California, 92093-0658

  • San Antonio Military Pediatric Cancer and Blood Disorders Center

    Lackland Air Force Base, Texas, 78236-5300

  • Norris Cotton Cancer Center

    Lebanon, New Hampshire, 03756-0002

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202-3591

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Jude Children's Research Hospital

    Memphis, Tennessee, 38105-2794

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, 33136

  • University of Miami-Jackson Memorial Hospital Medical Center

    Miami, Florida, 33136

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • University of South Alabama Medical Center

    Mobile, Alabama, 36617-2293

  • MBCCOP - Gulf Coast

    Mobile, Alabama, 36688

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8028

  • Schneider Children's Hospital

    New Hyde Park, New York, 11042

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Oklahoma Memorial Hospital

    Oklahoma City, Oklahoma, 73126-0307

  • Walt Disney Memorial Cancer Institute

    Orlando, Florida, 32803

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, California, 94304

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • Maine Children's Cancer Program

    Portland, Maine, 04101

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • Legacy Emanuel Hospital and Health Center

    Portland, Oregon, 97227

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • Carilion Roanoke Community Hospital

    Roanoke, Virginia, 24029

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • MBCCOP - South Texas Pediatric

    San Antonio, Texas, 78229-3900

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Kaiser Permanente-Southern California Permanente Medical Group

    San Diego, California, 92120

  • Children's Hospital and Health Center

    San Diego, California, 92123-4282

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051-5386

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • State University of New York Health Sciences Center - Stony Brook

    Stony Brook, New York, 11790-7775

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • CCOP - Florida Pediatric

    Tampa, Florida, 33682-7757

  • Scott and White Clinic

    Temple, Texas, 76508

  • Arizona Cancer Center

    Tucson, Arizona, 85724

  • Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5000

  • St. Mary's Hospital

    West Palm Beach, Florida, 33407

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Canada9 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Children's Hospital

    Hamilton, Ontario, L8N 3Z5

  • McGill University Health Center - Montreal Children's Hospital

    Montreal, Quebec, H3H 1P3

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Laval University Medical Center

    Sainte-Foy, Quebec, G1V 4G2

  • Centre Hospitalier de L'Universite Laval

    Sainte-Foy, Quebec, GIV 4G2

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Switzerland3 sites

  • Swiss Pediatric Oncology Group Bern

    Bern, CH 3010

  • Clinique de Pediatrie

    Geneva, 1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

Australia1 site

  • Royal Children's Hospital

    Parkville, Victoria, 3052

Other trials in Australia

Netherlands1 site

  • Academisch Ziekenhuis Groningen

    Groningen, 9713 EZ

Other trials in Netherlands

Puerto Rico1 site

  • San Jorge Childrens Hospital

    Santurce, 00912

Other trials in Puerto Rico

About this study

Official title: IL-2 Infusion in AML Patients After Autologous Bone Marrow Transplant: A Pediatric Oncology Group Wide Phase I Trial

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of interleukin-2 in treating children who have undergone bone marrow transplantation for acute myeloid leukemia.

Read the detailed description

OBJECTIVES: I. Determine the maximum tolerated dose of interleukin-2 after autologous bone marrow transplantation in pediatric patients with acute myeloid leukemia. II. Determine toxic effects of this regimen in these patients.

OUTLINE: This is a dose escalation study. Patients receive interleukin-2 (IL-2) subcutaneously on days 1-7, 9-14, and 16-22. On days 8 and 15, patients receive IL-2 IV over 2 hours. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6-9 patients receive escalating doses of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 or 2 of 9 patients experience dose-limiting toxicity. Patients are followed every 6 months for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 6-27 patients will be accrued for this study.

Conditions
Leukemia
Being tested
aldesleukin
Keywords
recurrent childhood acute myeloid leukemia, childhood acute myeloid leukemia in remission, childhood acute myeloblastic leukemia without maturation (M1), childhood acute myeloblastic leukemia with maturation (M2)
Medical subject headings
Leukemia

What participants receive

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

  • aldesleukinBiological

    Also called Recombinant Interleukin-2 (Chiron-Cetus) (IL-2), NSC -373364

    Given SQ and IV

Study groups in NCT00009698
Study groupRoleWhat they receive
All patientsExperimentalDay 1 through day 7, days 9-14 and days 16-22: The assigned dose of IL-2 will be administered SQ. On days 8 and 15, IL-2 will be administered as a 2 hour intravenous infusion of one million units/M2 of IL-2. After day 22 there will be a 7 day rest period before beginning the next cycle. The next cycle will repeat just as above. This will be repeated for a maximum of 4 total cycles of 21 days of IL-2 therapy. The maintenance dose of IL-2 will always be the same as given during cycle one, unless there is dose limiting toxicity.
Receives: Biological: aldesleukin

What is being measured

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

  1. To determine the maximum tolerated dose (MTD) of IL-2

    Measured: 2 years

Timeline

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

  1. First posted31 Dec 2003 (estimated)
  2. Study startMar 1998
  3. Primary completionJun 2001
  4. Study completionSep 2005

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
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00009698
Sponsor's protocol ID
9674
Other IDs
POG-9674, CDR0000065574
Status last verified
Jun 2013
First submitted
2 Feb 2001
Last updated
28 Jun 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing aldesleukin in people with Leukemia, run by Children's Oncology Group at 119 sites in 6 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 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 119 sites in United States, Canada, Switzerland, Australia, Netherlands and 1 more country. 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?

To determine the maximum tolerated dose (MTD) of IL-2 (time frame: 2 years). 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 NCT00009698.

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 Jun 2013.

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