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AzTrials

NeuroblastomaPhase 3NCT00004188

Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma

A Phase 3 study testing filgrastim, carboplatin and cisplatin in people with Neuroblastoma, run by Children's Oncology Group at 96 sites in 2 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Read more about this study

Who is it for?
Ages Up to 30 years
Conditions the study is for
Neuroblastoma
What is being tested?
filgrastim, carboplatin and cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
495 participants
Where
96 sitesin 2 countries
Study dates
Feb 2001to Oct 2007
Phase
Phase 3
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 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed neuroblastoma OR ganglioneuroblastoma, and/or evidence of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites, meeting 1 of the following criteria:
  • Age greater than 18 months with stage IV disease, regardless of biologic factors
  • Age 12-18 months with stage IV disease meeting one of the following criteria:
  • Any unfavorable biologic feature (e.g., MYCN amplification, unfavorable pathology, and/or DNA index = 1)
  • Any biologic feature that is indeterminate, unsatisfactory, or unknown
  • At least 1 year old with the following:
  • Stage IIa/IIb with MYCN amplification (> 10) AND unfavorable pathology
  • Stage III with MYCN amplification (> 10) OR unfavorable pathology
  • Stage I, II, or IVS with disease progression to stage IV without interval chemotherapy
  • No more than 3 weeks since progression
  • Must have been enrolled on protocol CCG-B973, COG-ANBL00B1, or POG-9047
  • Less than 1 year old with the following:
  • Stage III, IV, or IVS disease with MYCN amplification (> 10)
  • Registration on protocol COG-ANBL00B1 required within 14 days of diagnosis

PATIENT CHARACTERISTICS:

Age:

  • See Disease Characteristics
  • 30 and under at time of diagnosis

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Inadequate hematopoiesis secondary to bone marrow involvement with > 10% tumor infiltration allowed

Hepatic:

  • Bilirubin ≤ 1.5 mg/dL
  • ALT ≤ 300 units/L

Renal:

  • Creatinine ≤ 1.5 mg/dL
  • Creatinine clearance or glomerular filtration rate ≥ 60 mL/min

Cardiovascular:

  • ECG normal
  • Ejection fraction ≥ 55% by echocardiogram or MUGA OR
  • Fractional shortening ≥ 28% by echocardiogram

Other:

  • Able to tolerate peripheral blood stem cell collection
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for at least 1 month prior to, during, and for 1 month after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No more than 1 prior course of chemotherapy on the Intergroup low/intermediate risk neuroblastoma study (P9641, A3961)

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Prior localized emergency radiotherapy to sites of life-threatening or function-threatening disease allowed

Surgery:

  • Not specified

Other

  • No other prior systemic therapy

Trial locations and contacts

96 sites in 2 countries.

96 sites in 2 countries

United States86 sites

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-5636

  • Texas Tech University Health Sciences Center School of Medicine

    Amarillo, Texas, 79106

  • C.S. Mott Children's Hospital at University of Michigan

    Ann Arbor, Michigan, 48109-0238

  • Mission Hospitals - Memorial Campus

    Asheville, North Carolina, 28801

  • Children's Hospital of Austin

    Austin, Texas, 78701

  • Alvin and Lois Lapidus Cancer Institute at Sinai Hospital

    Baltimore, Maryland, 21215

  • CancerCare of Maine at Eastern Maine Medial Center

    Bangor, Maine, 04401

  • Comprehensive Cancer Center at University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Fletcher Allen Health Care - University Health Center Campus

    Burlington, Vermont, 05405

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Cancer Center at Presbyterian Hospital

    Charlotte, North Carolina, 28233-3549

  • University of Illinois at Chicago Cancer Center

    Chicago, Illinois, 60612-7243

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195-5217

  • Palmetto Health South Carolina Cancer Center

    Columbia, South Carolina, 29203

  • Columbus Children's Hospital

    Columbus, Ohio, 43205-2696

  • Children's Medical Center - Dayton

    Dayton, Ohio, 45404-1815

  • Children's Hospital Cancer Center

    Denver, Colorado, 80218-1088

  • Blank Children's Hospital

    Des Moines, Iowa, 50309

  • Southern California Permanente Medical Group

    Downey, California, 90242-2814

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center

    Farmington, Connecticut, 06360-2875

  • Broward General Medical Center Cancer Center

    Fort Lauderdale, Florida, 33316

  • Lee Cancer Care of Lee Memorial Health System

    Fort Myers, Florida, 33901

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104-9958

  • University of Florida Shands Cancer Center

    Gainesville, Florida, 32610-0232

  • Spectrum Health Cancer Care - Butterworth Campus

    Grand Rapids, Michigan, 49503-2560

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Grosse Pointe Woods, Michigan, 48236

  • Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Memorial Cancer Institute at Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Edwards Comprehensive Cancer Center at Cabell Huntington Hospital

    Huntington, West Virginia, 25701

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202-5289

  • St. Vincent Indianapolis Hospital

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1083

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-5341

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37916

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109-2306

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-0002

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0084

  • St. Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

    Long Beach, California, 90801

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

  • Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center

    Los Angeles, California, 90048-1865

  • Kosair Children's Hospital

    Louisville, Kentucky, 40232

  • Covenant Children's Hospital

    Lubbock, Texas, 79410

  • Children's Hospital Central California

    Madera, California, 93638-8762

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • Marshfield Clinic - Marshfield Center

    Marshfield, Wisconsin, 54449

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Children's Hospital of Minnesota - Minneapolis

    Minneapolis, Minnesota, 55404

  • Fairview University Medical Center - University Campus

    Minneapolis, Minnesota, 55455

  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals

    Morgantown, West Virginia, 26506

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • NYU Cancer Institute at New York University Medical Center

    New York, New York, 10016

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Children's Hospital of Omaha

    Omaha, Nebraska, 68114-4113

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-3330

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016-7710

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Cancer Institute at Oregon Health and Science University

    Portland, Oregon, 97239-3098

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Massey Cancer Center at Virginia Commonwealth University

    Richmond, Virginia, 23298-0037

  • Carilion Cancer Center of Western Virginia

    Roanoke, Virginia, 24029

  • Kaiser Permanente Medical Center - Oakland

    Sacramento, California, 95825

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78284-7811

  • Children's Hospital and Health Center - San Diego

    San Diego, California, 92123-4282

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Providence Cancer Center at Sacred Heart Medical Center

    Spokane, Washington, 99220-2555

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794-9620

  • Siteman Cancer Center at Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Stanford Cancer Center at Stanford University Medical Center

    Stanford, California, 94305

  • St. Joseph's Cancer Institute at St. Joseph's Hospital

    Tampa, Florida, 33607

  • Toledo Hospital

    Toledo, Ohio, 43606

  • Medical College of Ohio Cancer Institute

    Toledo, Ohio, 43614

  • New York Medical College

    Valhalla, New York, 10595

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

  • Kaplan Cancer Center at St. Mary's Medical Center

    West Palm Beach, Florida, 33407

Other trials in United States

Canada10 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5

  • Children's Hospital of Western Ontario

    London, Ontario, N6A 4G5

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H3H 1P3

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Janeway Children's Health and Rehabilitation Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Centre Hospitalier Universitaire de Quebec

    Ste-Foy, Quebec, G1V 4G2

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • Children's & Women's Hospital of British Columbia

    Vancouver, British Columbia, V6H 3V4

Other trials in Canada

About this study

Official title: A Randomized Study of Purged Versus Unpurged Peripheral Blood Stem Cell Transplant Following Dose Intensive Induction Therapy for High Risk Neuroblastoma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: This randomized phase III trial is studying peripheral stem cell transplantation with treated peripheral stem cells following combination chemotherapy to see how well it works compared to peripheral stem cell transplantation with untreated peripheral stem cells following combination chemotherapy in treating patients with neuroblastoma.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the event-free survival in patients with newly diagnosed high risk neuroblastoma or ganglioneuroblastoma treated with myeloablative consolidation chemotherapy and autologous purged versus unpurged peripheral blood stem cells (PBSC).
  • Compare the time to engraftment and CD34 content and tumor content by reverse transcriptase polymerase chain reaction (RT-PCR) of purged versus unpurged PBSC in patients treated with these regimens.
  • Determine event-free survival of patients treated with dose intensive induction chemotherapy comprising cyclophosphamide, doxorubicin, and vincristine alternating with cisplatin and etoposide.
  • Determine the toxicity of this dose-intensive induction chemotherapy regimen in these patients.
  • Evaluate tumor resectability at second look or delayed surgery, response (complete response and very good partial response) at completion of induction therapy, tumor content of peripheral blood and bone marrow, and the comparison of historical data from CCG-3891 induction therapy in these patients.

Secondary

  • Compare the toxicity of this myeloablative consolidation regimen using purged vs unpurged PBSC in these patients.
  • Determine if event-free survival is predictable by RT-PCR positivity of the stem cell, minimal residual disease in bone marrow and peripheral blood after transplantation by immunocytology, and extent of disease as measured by MIBG after transplantation in patients treated with these regimens.
  • Evaluate the prognostic impact of tumor biology on event free survival in patients treated with these regimens.
  • Determine the incidence of relapse in the primary site after radiotherapy and in irradiated versus unirradiated metastatic sites in these patients.
  • Assess the toxicity and tolerability of maintenance therapy with topotecan and cyclophosphamide after intensive induction therapy in patients who decline or are unable to receive myeloablative therapy.
  • Determine the health-related quality of life of patients treated with these regimens.
  • Compare late effects of these regimens on the growth, endocrine, pulmonary, and cardiac function of these patients vs general population standards.
  • Determine the incidence of second malignant neoplasms in patients treated with these regimens.
  • Determine the variability of isotretinoin pharmacokinetics and relationship to pharmacogenomic parameters in these patients.
  • Correlate the isotretinoin pharmacokinetics and pharmacogenomic parameters and/or genetic variations in isotretinoin metabolic enzymes with event-free survival or systemic toxicity in these patients.

OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms for peripheral blood stem cell (PBSC) collection.

All patients receive induction chemotherapy comprising cyclophosphamide IV over 6 hours on days 0 and 1, doxorubicin IV and vincristine IV continuously over 72 hours on days 0-2, and filgrastim (G-CSF) subcutaneously (SC) or IV beginning on day 3 and continuing until blood counts recover for courses 1, 2, 4, and 6. Treatment alternates with courses 3 and 5 comprising etoposide IV over 2 hours on days 0-2, cisplatin IV over 1 hour on days 0-3, and G-CSF SC or IV beginning on day 4 and continuing until blood counts recover. Induction chemotherapy repeats every 3 weeks or when blood counts recover in the absence of disease progression or unacceptable toxicity.

After course 2 or 3 of induction chemotherapy, patients undergo PBSC collection, either purged or unpurged, depending on randomization. Patients continue on daily G-CSF until cell collection is complete.

  • Arm I: Patients undergo unpurged PBSC collection until the target cell count is reached.
  • Arm II: Patients undergo purged PBSC collection until the target cell count is reached.

Patients with immunocytology positive PBSC undergo purged autologous bone marrow collection or repeat purged or unpurged PBSC collection depending on individual patient characteristics.

All patients undergo delayed surgical resection of the residual tumor after course 5 of induction chemotherapy.

After induction therapy, patients achieving complete response, very good partial response, or partial response receive consolidation therapy comprising melphalan IV on days -7 to -5 followed by carboplatin IV and etoposide IV continuously over days -7 to -4. Patients receive purged or unpurged PBSC infusion or purged autologous bone marrow transplantation on day 0 followed by G-CSF SC or IV beginning 4 hours after completion of transplantation and continuing until blood counts recover. Beginning on day 66, patients receive oral isotretinoin twice daily for 14 days. Isotretinoin therapy repeats every 4 weeks for 6 courses.

After completion of consolidation (at least 28 days from stem cell infusion), all patients receive local radiotherapy daily over 7 days.

Patients not undergoing transplantation or who are ineligible for consolidation therapy receive maintenance therapy comprising cyclophosphamide IV over 30 minutes followed by topotecan IV over 30 minutes on days 0-4. Patients receive G-CSF SC or IV beginning on day 5 and continuing until blood counts recover. Maintenance therapy repeats every 3 weeks for 3 courses. After completion of maintenance therapy, patients receive radiotherapy as outlined above. Patients then receive oral isotretinoin twice daily for 14 days. Isotretinoin therapy repeats every 4 weeks for 6 courses.

Quality of life is assessed at 1* and 5 years.

Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually thereafter or until disease progression.

NOTE: * Patients under 5 years of age at 1 year are not assessed until 5 years.

PROJECTED ACCRUAL: A total of 486 patients will be accrued for this study within 4 years.

Conditions
Neuroblastoma
Keywords
localized resectable neuroblastoma, regional neuroblastoma, disseminated neuroblastoma, stage 4S neuroblastoma, localized unresectable neuroblastoma
Medical subject headings
Neuroblastoma

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, G-CSF, Neupogen

    Given IV

  • carboplatinDrug

    Also called Paraplatin, NSC #241240

    Given IV

  • cisplatinDrug

    Also called Cis-diamminedichloroplatinum II, Platinol-AQ, NSC #11987

    Given IV

  • cyclophosphamideDrug

    Also called CTX, Cytoxan, NSC #026271

    Given IV

  • doxorubicin hydrochlorideDrug

    Also called Adriamycin, NSC #123127, IND #7038

    Given IV

  • etoposideDrug

    Also called VP-16, VePesid, Etopophos, NSC #141540

    Given IV

  • isotretinoinDrug

    Also called 13-cis-retinoic acid, RO-43, 780, Accutane

    Given IV

  • melphalanDrug

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

    Given IV

  • topotecan hydrochlorideDrug

    Also called SKF-104864, Hycamtin, NSC #609699

    Given IV

  • vincristine sulfateDrug

    Also called VCR, Oncovin, NSC #067574

    Given IV

  • autologous bone marrow transplantationProcedure or surgery

  • bone marrow ablation with stem cell supportProcedure or surgery

  • conventional surgeryProcedure or surgery

    All patients undergo delayed surgical resection of the residual tumor after course 5 of induction chemotherapy

  • peripheral blood stem cell transplantationProcedure or surgery

  • radiation therapyRadiation

    After completion of consolidation (at least 28 days from stem cell infusion), all patients receive local radiotherapy daily over 7 days

Study groups in NCT00004188
Study groupRoleWhat they receive
Arm I (unpurged PBSC collection)ExperimentalInduction-3 wks (cyclophosphamide day 0\&1, doxorubicin hydrochloride \& vincristine sulfate day 0-2 \& filgrastim(G-CSF) day 3 crs 1,2,4 \& 6.) Crs 3 \& 5 (etoposide day 0-2, cisplatin day 0-3, G-CSF day 4). Pts undergo unpurged PBSC collection until the target cell count is reached. Surgical resection of the tumor after crs 5 of induct. CR, VGPR, PR after induct receive consolidation (melphalan day -7 to -5, carboplatin \& etoposide day -7 to -4. purged peripheral blood stem cell transplantation infusion day 0, G-CSF 4 hrs post transplant. Day 66, isotretinoin 2x day/14 days. Isotretinoin every 4 wks 6 crs. After consol (28 days from stem cell infusion), radiation therapy 1x day/7 days. Not undergoing autologous bone marrow transplantation receive maintenance(cyclophosphamide 30 mins, topotecan hydrochloride days 0-4, G-CSF day 5). Maint every 3 wks/3 crs. Radiation therapy and Isotretinoin 2x day/14 days then every 4 wks for 6 crs.
Receives: Biological: filgrastim; Drug: carboplatin; Drug: cisplatin; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: isotretinoin; Drug: melphalan; Drug: topotecan hydrochloride; Drug: vincristine sulfate; Procedure: autologous bone marrow transplantation; Procedure: bone marrow ablation with stem cell support; Procedure: conventional surgery; Procedure: peripheral blood stem cell transplantation; Radiation: radiation therapy
Arm II (unpurged PBSC collection)ExperimentalInduction-3 wks (cyclophosphamide day 0\&1, doxorubicin hydrochloride \& vincristine sulfate day 0-2 \& filgrastim(G-CSF) day 3 crs 1,2,4 \& 6.) Crs 3 \& 5 (etoposide day 0-2, cisplatin day 0-3, G-CSF day 4). Immunocytology + PBSC undergo purged autologous bone marrow collection or repeat purged or unpurged PBSC collection. Surgical resection of the tumor after crs 5 of induct. CR, VGPR, PR after induct receive consolidation (melphalan day -7 to -5, carboplatin \& etoposide day -7 to -4. Unpurged peripheral blood stem cell transplantation infusion day 0, G-CSF 4 hrs post transplant. Day 66, isotretinoin 2x day/14 days. Isotretinoin every 4 wks 6 crs. After consol (28 days from stem cell infusion), radiation therapy 1x day/7 days. Not undergoing autologous bone marrow transplantation receive maintenance(cyclophosphamide 30 mins, topotecan hydrochloride days 0-4, G-CSF day 5). Maint every 3 wks/3 crs. Radiation therapy and Isotretinoin 2x day/14 days then every 4 wks for 6 crs.
Receives: Drug: carboplatin; Drug: cisplatin; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: etoposide; Drug: isotretinoin; Drug: melphalan; Drug: topotecan hydrochloride; Drug: vincristine sulfate; Procedure: autologous bone marrow transplantation; Procedure: bone marrow ablation with stem cell support; Procedure: conventional surgery; Procedure: peripheral blood stem cell transplantation; Radiation: radiation therapy

What is being measured

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

  1. Event-free survival rate

    Measured: Time from study registration until the time of the first occurrence of either relapse, progression, secondary malignancy, or death, or until the time of last contact with the patient if none of these events occurs, assessed up to 6 years

  2. Rate of occurrence of toxic (non disease-related) deaths where a toxic death will be "counted" if it occurs prior to the initiation of the immunotherapy

    Measured: Up to day 42

Secondary outcomes (3)

  1. Time to engraftment

    Engraftment is defined as three consecutive measurements of ANC > 500.

    Measured: Up to 6 years

  2. CD34 content

    Measured: Up to 6 years

  3. Tumor content as measured by reverse transcriptase polymerase chain reaction

    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 completionOct 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
495 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00004188
Sponsor's protocol ID
A3973
Other IDs
COG-A3973, CCG-A3973, POG-A3973, CCG-39703, FHCRC-1631.00, CDR0000067429
Status last verified
May 2013
First submitted
21 Jan 2000
Last updated
17 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Dubois SG, Geier E, Batra V, Yee SW, Neuhaus J, Segal M, Martinez D, Pawel B, Yanik G, Naranjo A, London WB, Kreissman S, Baker D, Attiyeh E, Hogarty MD, Maris JM, Giacomini K, Matthay KK. Evaluation of Norepinephrine Transporter Expression and Metaiodobenzylguanidine Avidity in Neuroblastoma: A Report from the Children's Oncology Group. Int J Mol Imaging. 2012;2012:250834. doi: 10.1155/2012/250834. Epub 2012 Sep 25.

    PubMed 23050139

  • Cantos MF, Gerstle JT, Irwin MS, Pappo A, Farley S, Cheang T, Kim PC. Surgical challenges associated with intensive treatment protocols for high-risk neuroblastoma. J Pediatr Surg. 2006 May;41(5):960-5. doi: 10.1016/j.jpedsurg.2006.01.059.

    PubMed 16677893

  • Kushner BH, Budnick A, Kramer K, Modak S, Cheung NK. Ototoxicity from high-dose use of platinum compounds in patients with neuroblastoma. Cancer. 2006 Jul 15;107(2):417-22. doi: 10.1002/cncr.22004.

    PubMed 16779793

  • Landier W, Knight K, Wong FL, Lee J, Thomas O, Kim H, Kreissman SG, Schmidt ML, Chen L, London WB, Gurney JG, Bhatia S. Ototoxicity in children with high-risk neuroblastoma: prevalence, risk factors, and concordance of grading scales--a report from the Children's Oncology Group. J Clin Oncol. 2014 Feb 20;32(6):527-34. doi: 10.1200/JCO.2013.51.2038. Epub 2014 Jan 13.

    PubMed 24419114

  • Naranjo A, Parisi MT, Shulkin BL, London WB, Matthay KK, Kreissman SG, Yanik GA. Comparison of (1)(2)(3)I-metaiodobenzylguanidine (MIBG) and (1)(3)(1)I-MIBG semi-quantitative scores in predicting survival in patients with stage 4 neuroblastoma: a report from the Children's Oncology Group. Pediatr Blood Cancer. 2011 Jul 1;56(7):1041-5. doi: 10.1002/pbc.22991. Epub 2011 Feb 15.

    PubMed 21328522

  • Yanik GA, Parisi MT, Naranjo A, et al.: MIBG scoring as a prognostic indicator in patients with stage IV neuroblastoma: A COG study. [Abstract] J Clin Oncol 28 (Suppl 15): A-9516, 2010.

  • Kreissman SG, Villablanca JG, Diller L, et al.: Response and toxicity to a dose-intensive multi-agent chemotherapy induction regimen for high risk neuroblastoma (HR-NB): a Children's Oncology Group (COG A3973) study. [Abstract] J Clin Oncol 25 (Suppl 18): A-9505, 527s, 2007.

  • Kreissman SG, Seeger RC, Matthay KK, London WB, Sposto R, Grupp SA, Haas-Kogan DA, Laquaglia MP, Yu AL, Diller L, Buxton A, Park JR, Cohn SL, Maris JM, Reynolds CP, Villablanca JG. Purged versus non-purged peripheral blood stem-cell transplantation for high-risk neuroblastoma (COG A3973): a randomised phase 3 trial. Lancet Oncol. 2013 Sep;14(10):999-1008. doi: 10.1016/S1470-2045(13)70309-7. Epub 2013 Jul 25.

    PubMed 23890779

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing filgrastim, carboplatin and cisplatin in people with Neuroblastoma, run by Children's Oncology Group at 96 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 17 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 96 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Event-free survival rate (time frame: Time from study registration until the time of the first occurrence of either relapse, progression, secondary malignancy, or death, or until the time of last contact with the patient if none of these events occurs, assessed up to 6 years). 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 NCT00004188, which also lists 8 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 17 May 2013.

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