Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Neuroblastoma
NCT ID: NCT00004188
Last Updated: 2013-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
495 participants
INTERVENTIONAL
2001-02-28
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm I (unpurged PBSC collection)
Induction-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.
filgrastim
Given IV
carboplatin
Given IV
cisplatin
Given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
etoposide
Given IV
isotretinoin
Given IV
melphalan
Given IV
topotecan hydrochloride
Given IV
vincristine sulfate
Given IV
autologous bone marrow transplantation
bone marrow ablation with stem cell support
conventional surgery
All patients undergo delayed surgical resection of the residual tumor after course 5 of induction chemotherapy
peripheral blood stem cell transplantation
radiation therapy
After completion of consolidation (at least 28 days from stem cell infusion), all patients receive local radiotherapy daily over 7 days
Arm II (unpurged PBSC collection)
Induction-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.
carboplatin
Given IV
cisplatin
Given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
etoposide
Given IV
isotretinoin
Given IV
melphalan
Given IV
topotecan hydrochloride
Given IV
vincristine sulfate
Given IV
autologous bone marrow transplantation
bone marrow ablation with stem cell support
conventional surgery
All patients undergo delayed surgical resection of the residual tumor after course 5 of induction chemotherapy
peripheral blood stem cell transplantation
radiation therapy
After completion of consolidation (at least 28 days from stem cell infusion), all patients receive local radiotherapy daily over 7 days
Interventions
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filgrastim
Given IV
carboplatin
Given IV
cisplatin
Given IV
cyclophosphamide
Given IV
doxorubicin hydrochloride
Given IV
etoposide
Given IV
isotretinoin
Given IV
melphalan
Given IV
topotecan hydrochloride
Given IV
vincristine sulfate
Given IV
autologous bone marrow transplantation
bone marrow ablation with stem cell support
conventional surgery
All patients undergo delayed surgical resection of the residual tumor after course 5 of induction chemotherapy
peripheral blood stem cell transplantation
radiation therapy
After completion of consolidation (at least 28 days from stem cell infusion), all patients receive local radiotherapy daily over 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
30 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Susan G. Kreissman, MD
Role: STUDY_CHAIR
Duke Cancer Institute
Locations
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Comprehensive Cancer Center at University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Southern California Permanente Medical Group
Downey, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
Long Beach, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Kaiser Permanente Medical Center - Oakland
Sacramento, California, United States
Children's Hospital and Health Center - San Diego
San Diego, California, United States
UCSF Comprehensive Cancer Center
San Francisco, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
Children's Hospital Cancer Center
Denver, Colorado, United States
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
Farmington, Connecticut, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States
Lee Cancer Care of Lee Memorial Health System
Fort Myers, Florida, United States
University of Florida Shands Cancer Center
Gainesville, Florida, United States
Memorial Cancer Institute at Memorial Regional Hospital
Hollywood, Florida, United States
All Children's Hospital
St. Petersburg, Florida, United States
St. Joseph's Cancer Institute at St. Joseph's Hospital
Tampa, Florida, United States
Kaplan Cancer Center at St. Mary's Medical Center
West Palm Beach, Florida, United States
University of Illinois at Chicago Cancer Center
Chicago, Illinois, United States
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States
Southern Illinois University School of Medicine
Springfield, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
St. Vincent Indianapolis Hospital
Indianapolis, Indiana, United States
Blank Children's Hospital
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
CancerCare of Maine at Eastern Maine Medial Center
Bangor, Maine, United States
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, Maryland, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States
C.S. Mott Children's Hospital at University of Michigan
Ann Arbor, Michigan, United States
Spectrum Health Cancer Care - Butterworth Campus
Grand Rapids, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States
CCOP - Kalamazoo
Kalamazoo, Michigan, United States
Breslin Cancer Center at Ingham Regional Medical Center
Lansing, Michigan, United States
Children's Hospital of Minnesota - Minneapolis
Minneapolis, Minnesota, United States
Fairview University Medical Center - University Campus
Minneapolis, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States
Children's Hospital of Omaha
Omaha, Nebraska, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha, Nebraska, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
St. Barnabas Medical Center
Livingston, New Jersey, United States
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Newark Beth Israel Medical Center
Newark, New Jersey, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States
University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
NYU Cancer Institute at New York University Medical Center
New York, New York, United States
New York Medical College
Valhalla, New York, United States
Mission Hospitals - Memorial Campus
Asheville, North Carolina, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Presbyterian Cancer Center at Presbyterian Hospital
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Columbus Children's Hospital
Columbus, Ohio, United States
Children's Medical Center - Dayton
Dayton, Ohio, United States
Toledo Hospital
Toledo, Ohio, United States
Medical College of Ohio Cancer Institute
Toledo, Ohio, United States
Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Palmetto Health South Carolina Cancer Center
Columbia, South Carolina, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States
East Tennessee Children's Hospital
Knoxville, Tennessee, United States
Texas Tech University Health Sciences Center School of Medicine
Amarillo, Texas, United States
Children's Hospital of Austin
Austin, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Covenant Children's Hospital
Lubbock, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, United States
Massey Cancer Center at Virginia Commonwealth University
Richmond, Virginia, United States
Carilion Cancer Center of Western Virginia
Roanoke, Virginia, United States
Providence Cancer Center at Sacred Heart Medical Center
Spokane, Washington, United States
Edwards Comprehensive Cancer Center at Cabell Huntington Hospital
Huntington, West Virginia, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States
Alberta Children's Hospital
Calgary, Alberta, Canada
Children's & Women's Hospital of British Columbia
Vancouver, British Columbia, Canada
Janeway Children's Health and Rehabilitation Centre
St. John's, Newfoundland and Labrador, Canada
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada
Children's Hospital of Western Ontario
London, Ontario, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Hospital for Sick Children
Toronto, Ontario, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
Ste-Foy, Quebec, Canada
Allan Blair Cancer Centre at Pasqua Hospital
Regina, Saskatchewan, Canada
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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COG-A3973
Identifier Type: OTHER
Identifier Source: secondary_id
CCG-A3973
Identifier Type: OTHER
Identifier Source: secondary_id
POG-A3973
Identifier Type: OTHER
Identifier Source: secondary_id
CCG-39703
Identifier Type: OTHER
Identifier Source: secondary_id
FHCRC-1631.00
Identifier Type: -
Identifier Source: secondary_id
CDR0000067429
Identifier Type: OTHER
Identifier Source: secondary_id
A3973
Identifier Type: -
Identifier Source: org_study_id
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