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LeukemiaPhase 2NCT00002704

Radiation Therapy and Chemotherapy in Treating Children With CNS Relapse From Acute Lymphoblastic Leukemia

A Phase 2 study testing filgrastim, asparaginase and cyclophosphamide in people with Leukemia, run by National Cancer Institute (NCI) at 70 sites in 4 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

Phase II trial to study the effectiveness of radiation therapy following chemotherapy in treating children with CNS relapse from acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages Up to 20 years
Conditions the study is for
Leukemia
What is being tested?
filgrastim, asparaginase and cyclophosphamide
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
70 sitesin 4 countries
Study dates
Jan 1996to Jun 2004
Phase
Phase 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 Up to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Acute lymphoblastic leukemia in first bone marrow remission (M1) with first isolated initial CNS relapse
  • More than 5 WBC/microliter in cerebrospinal fluid (CSF) with blasts on cytospin OR immunophenotypic proof (encouraged) of relapse in CSF
  • Identifiable blasts and presence on 2 CSF samples 3 weeks apart
  • If B-cell terminal deoxynucleotidyl transferase (TdT) OR CD-10
  • If T-cell TdT alone OR with CD-7

PATIENT CHARACTERISTICS:

  • Age: Over 6 months and under 21 years at relapse
  • Patients receiving sustained release cytarabine
  • Performance status: Older than 10 years
  • Karnofsky greater than 50% Less than 10 years
  • Lansky greater than 50%
  • Platelet count greater than 40,000/mm3
  • Bilirubin less than 2.0 mg/dL
  • SGPT less than 5 times normal
  • Creatinine less than 1.5 times normal for age
  • Normal metabolic parameters (serum electrolytes, calcium, and phosphorus)
  • No clinical evidence of obstructive hydrocephalus, compartmentalization of the CSF flow, ventriculoperitoneal or ventriculoatrial shunt

PRIOR CONCURRENT THERAPY:

  • Prior cumulative anthracycline dose less than 375 mg/sqm
  • Patients receiving sustained release cytarabine
  • At least 7 days since prior investigational drug
  • At least 3 weeks since prior CNS directed therapy (6 weeks is prior nitrosourea)
  • At least 1 week since intrathecal chemotherapy
  • At least 8 weeks since prior craniospinal radiotherapy

Trial locations and contacts

70 sites in 4 countries.

70 sites in 4 countries

United States62 sites

  • Memorial Mission Hospital

    Asheville, North Carolina, 28801

  • Emory University Hospital - Atlanta

    Atlanta, Georgia, 30322

  • Marlene & Stewart Greenebaum Cancer Center, University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins Oncology Center

    Baltimore, Maryland, 21287

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35294

  • Boston Floating Hospital Infants and Children

    Boston, Massachusetts, 02111

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Healthcare

    Charlotte, North Carolina, 28233-3549

  • Cancer Center, University of Virginia HSC

    Charlottesville, Virginia, 22908

  • Children's Memorial Hospital, Chicago

    Chicago, Illinois, 60614

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center - Dallas

    Dallas, Texas, 75235-9154

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Shands Hospital and Clinics, University of Florida

    Gainesville, Florida, 32610-100277

  • 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

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160-7357

  • 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

  • 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

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • MBCCOP - University of South Alabama

    Mobile, Alabama, 36688

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9162

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8028

  • Schneider Children's Hospital

    New Hyde Park, New York, 11042

  • MBCCOP - LSU Medical 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

  • Oklahoma Memorial Hospital

    Oklahoma City, Oklahoma, 73126-0307

  • Lucile Packard Children's Hospital at Stanford

    Palo Alto, California, 94304

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • CCOP - Columbia River Program

    Portland, Oregon, 97213

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-2197

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Massey Cancer Center

    Richmond, Virginia, 23298-0037

  • University of Rochester Cancer Center

    Rochester, New York, 14642

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • MBCCOP - South Texas Pediatric

    San Antonio, Texas, 78284-7810

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Children's Hospital and Health Center

    San Diego, California, 92123-4282

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • Washington University School of Medicine

    St Louis, Missouri, 63110

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

    Stony Brook, New York, 11790-9832

  • State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • CCOP - Florida Pediatric

    Tampa, Florida, 33682-7757

  • Walter Reed Army Medical Center

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

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157-1082

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Canada5 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • McMaster Division

    Hamilton, Ontario, L8N 3Z5

  • Montreal Children's Hospital

    Montreal, Quebec, H3H 1P3

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Switzerland2 sites

  • Swiss Pediatric Oncology Group Bern

    Bern, CH 3010

  • Clinique de Pediatrie

    Geneva, 1211

Other trials in Switzerland

Puerto Rico1 site

  • University of Puerto Rico School of Medicine Medical Sciences Campus

    San Juan, 00936-5067

Other trials in Puerto Rico

About this study

Official title: TREATMENT OF ISOLATED CNS RELAPSE OF ACUTE LYMPHOBLASTIC LEUKEMIA -- A PEDIATRIC ONCOLOGY GROUP-WIDE PHASE II STUDY

Phase II trial to study the effectiveness of radiation therapy following chemotherapy in treating children with CNS relapse from acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more cancer cells.

Read the detailed description

OBJECTIVES:

  1. Determine the efficacy and toxicity of intensified systemic treatment with delayed central nervous system (CNS) irradiation in children with acute lymphoblastic leukemia and isolated CNS disease.

II. Determine the efficacy of systemic thiotepa in reducing or clearing blasts in the cerebrospinal fluid of these patients.

III. Evaluate the toxicity of single dose thiotepa followed by dexamethasone, vincristine, daunorubicin, and triple intrathecal therapy in these patients.

IV. Determine the response rate of intrathecal sustained release cytarabine (DTC101) in patients with first bone marrow remission with first isolated CNS relapse.

  1. Assess the safety and toxicity of DTC101 in these patients.

OUTLINE:

Patients with significant neurologic symptoms (e.g., seizures, cranial nerve palsy, paresis, mental status changes) are entered directly on the Induction regimen and do not receive the Therapeutic Window. The following acronyms are used: ARA-C Cytarabine, NSC-63878 ASP Asparaginase, NSC-109229 (E. coli) or 106977 (Erwinia) CF Leucovorin calcium, NSC-3590 CTX Cyclophosphamide, NSC-26271 DM Dexamethasone, NSC-34521 DNR Daunorubicin, NSC-82151 DTC101 Sustained release cytarabine G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 HC Hydrocortisone, NSC-10483 Mesna Mercaptoethane sulfonate, NSC-113891 MP Mercaptopurine, NSC-755 MTX Methotrexate, NSC-740 TIT Triple Intrathecal Therapy, IT MTX/IT HC/IT ARA-C TMP-SMX Trimethoprim-sulfamethoxazole TSPA Thiotepa, NSC-6396 VCR Vincristine, NSC-67574 VP-16 Etoposide, NSC-141540

THERAPEUTIC WINDOW: Single Agent Chemotherapy. TSPA or DTC101. Thiotepa window closed as of 7/6/98 DTC101 window opened 11/15/99

INDUCTION: 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT.

CONSOLIDATION: 2-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. ARA-C/ASP; plus TIT.

INTENSIFICATION I: 4-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. CTX/MP/MTX/VP-16; with CF; plus TIT.

RE-INDUCTION: 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT.

INTENSIFICATION II: 6-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. ARA-C/ASP/CTX/MP/MTX/VP-16; with CF; plus TIT.

CHEMORADIOTHERAPY: Radiotherapy plus 3-Drug Combination Chemotherapy. Craniospinal irradiation using x-rays with energies of 4-6 MV (electrons acceptable for spinal cord irradiation); plus ASP/DM/VCR.

MAINTENANCE: 2-Drug Combination Chemotherapy Alternating with 2-Drug Combination Chemotherapy. MP/MTX; alternating with CTX/VCR.

Conditions
Leukemia
Being tested
filgrastim, asparaginase, cyclophosphamide, daunorubicin hydrochloride, dexamethasone
Keywords
recurrent childhood acute lymphoblastic leukemia, T-cell childhood acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia, TdT positive childhood acute lymphoblastic leukemia
Medical subject headings
Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

Study groups in NCT00002704
Study groupRoleWhat they receive
Arm IExperimentalSingle Agent Chemotherapy. TSPA or DTC101. 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT. 2-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. ARA-C/ASP; plus TIT. 4-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. CTX/MP/MTX/VP-16; with CF; plus TIT. 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT. 6-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. ARA-C/ASP/CTX/MP/MTX/VP-16; with CF; plus TIT. Radiotherapy plus 3-Drug Combination Chemotherapy. Craniospinal irradiation using x-rays with energies of 4-6 MV (electrons acceptable for spinal cord irradiation); plus ASP/DM/VCR. 2-Drug Combination Chemotherapy Alternating with 2-Drug Combination Chemotherapy. MP/MTX; alternating with CTX/VCR.
Receives: Biological: filgrastim; Drug: asparaginase; Drug: cyclophosphamide; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: etoposide; Drug: leucovorin calcium; Drug: liposomal cytarabine; Drug: mercaptopurine; Drug: mesna; Drug: methotrexate; Drug: therapeutic hydrocortisone; Drug: thiotepa; Drug: vincristine sulfate; Radiation: low-LET electron therapy; Radiation: low-LET photon therapy

Timeline

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

  1. First posted1 Jul 2004 (estimated)
  2. Study startJan 1996
  3. Primary completionJun 2004

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002704
Sponsor's protocol ID
NCI-2012-01528
Other IDs
POG-9412, CDR0000064509
Status last verified
Nov 2007
First submitted
1 Nov 1999
Last updated
1 Feb 2013
Results posted
No

Publications

  • Eapen M, Zhang MJ, Devidas M, Raetz E, Barredo JC, Ritchey AK, Godder K, Grupp S, Lewis VA, Malloy K, Carroll WL, Davies SM, Camitta BM; Children's Oncology Group; Center for International Blood and Marrow Transplant Research. Outcomes after HLA-matched sibling transplantation or chemotherapy in children with acute lymphoblastic leukemia in a second remission after an isolated central nervous system relapse: a collaborative study of the Children's Oncology Group and the Center for International Blood and Marrow Transplant Research. Leukemia. 2008 Feb;22(2):281-6. doi: 10.1038/sj.leu.2405037. Epub 2007 Nov 22.

    PubMed 18033318

  • Barredo JC, Devidas M, Lauer SJ, Billett A, Marymont M, Pullen J, Camitta B, Winick N, Carroll W, Ritchey AK. Isolated CNS relapse of acute lymphoblastic leukemia treated with intensive systemic chemotherapy and delayed CNS radiation: a pediatric oncology group study. J Clin Oncol. 2006 Jul 1;24(19):3142-9. doi: 10.1200/JCO.2005.03.3373.

    PubMed 16809737

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, asparaginase and cyclophosphamide in people with Leukemia, run by National Cancer Institute (NCI) at 70 sites in 4 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 1 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, Canada, Switzerland, Puerto Rico. 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 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.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002704, which also lists 2 linked publications.

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 1 Feb 2013.

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