Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk Neuroblastoma



Status:Active, not recruiting
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 30
Updated:1/14/2017
Start Date:November 2007

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Phase III Randomized Trial of Single vs. Tandem Myeloablative Consolidation Therapy for High-Risk Neuroblastoma

This randomized phase III trial compares two different high-dose myeloablative chemotherapy
regimens followed by autologous stem cell transplant as consolidation treatment of younger
patients with high-risk neuroblastoma. All patients receive the same 6 cycles of initial
multi-agent chemotherapy induction regimen. Peripheral blood stem cells are collected after
the 2nd cycle of chemotherapy. Drugs used in chemotherapy work in different ways to stop the
growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving
combination chemotherapy before surgery may make the tumor smaller and reduce the amount of
normal tissue that needs to be removed. Patients underwent resection of their primary tumor
mass after 5 cycles of chemotherapy. Those patients without progressive disease at
completion of induction therapy who has sufficient stem cells collected and had adequate
organ function were eligible to proceed to consolidation therapy. Those patients who met
consolidation eligibility were randomized to either a single myeloablative regimen or 2
myeloablative regimens delivered in tandem followed by re-infusion of autologous stem cells.
Patients received radiation therapy after recovery from the assigned myeloablative therapy.
It is not yet known which regimen of high-dose chemotherapy is more effective for patients
with high-risk neuroblastoma undergoing a peripheral blood stem cell transplant.

PRIMARY OBJECTIVES:

I. To improve the 3-year event-free survival (EFS) rate of high-risk neuroblastoma patients
through treatment with a tandem consolidation of thiotepa/cyclophosphamide followed by
carboplatin/etoposide/melphalan (CEM) as compared to single CEM consolidation.

II. To improve the rate of end-induction complete response and very good partial response,
compared to historical controls, by use of a topotecan-containing induction regimen.

III. To improve the 3-year local control rate, compared to historical controls, by
increasing the local dose of radiation to the residual primary tumor for patients with less
than a gross total resection.

SECONDARY OBJECTIVES:

I. To evaluate the pharmacogenetic relationship of cyclophosphamide metabolizing enzymes
(i.e., cytochrome p 450 2B6 [CYP2B6], CYP2C9, and glutathione S-transferase alpha 1 [GSTA1]
genotypes) with toxicity and response following dose-intensive cyclophosphamide and
topotecan induction chemotherapy.

II. To determine if resection completeness is predictive of local control rate or EFS rate
in patients with high-risk neuroblastoma.

III. To prospectively describe the complications related to efforts at local control (i.e.,
surgery and radiotherapy) in patients with high-risk neuroblastoma.

IV. To describe the neurologic outcome of patients with paraspinal primary neuroblastoma
tumors.

V. To determine the variability of isotretinoin pharmacokinetics (PKs) and relationship to
pharmacogenomic parameters.

VI. To determine if isotretinoin PK levels are predictive of the EFS rate or associated with
systemic toxicity following isotretinoin.

VII. To determine if pharmacogenomic variations are predictive of the EFS rate or associated
with systemic toxicity following isotretinoin.

VIII. To evaluate total topotecan PKs and correlate with patient specific data for use in an
ongoing topotecan population PK analysis.

IX. To evaluate the presence and function of T cells capable of recognizing neuroblastoma by
assessing the following; if T cells recognizing the neuroblastoma antigen, survivin,
circulate at diagnosis; if these T cells can be expanded using autologous antigen presenting
cells (APCs); if these T cells will kill neuroblastoma cells as detected in functional
assays; and if the presence and activity of anti-neuroblastoma immunity is decreased by stem
cell transplantation.

X. To characterize the recovery of T-cell numbers after myeloablative consolidation and
hematopoietic stem cell transplantation (HSCT) and to assess the impact of tandem
myeloablative consolidation on T-cell recovery.

XI. To characterize minimal residual disease burden using reverse transcriptase-polymerase
chain reaction (RT-PCR) evaluation of a panel of neuroblastoma specific transcripts in
patient bone marrow and peripheral blood following induction chemotherapy and after single
versus tandem myeloablative chemotherapy and to evaluate impact on EFS.

XII. To evaluate the EFS and overall survival of patients nonrandomly assigned to treatment
with single myeloablative transplant (Arm A).

OUTLINE:

INDUCTION CHEMOTHERAPY:

COURSES 1 AND 2: Patients receive cyclophosphamide IV over 30 minutes and topotecan
hydrochloride IV over 30 minutes on days 1-5 and filgrastim (G-CSF) subcutaneously (SC) or
IV beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21
days for 2 courses. Patients undergo peripheral blood stem cell (PBSC) mobilization and
harvest after course 2.

COURSES 3 AND 5: Patients receive cisplatin IV over 1 hour on days 1-4, etoposide IV over 1
hour on days 1-3, and G-CSF SC or IV beginning on day 5 and continuing until blood counts
recover. Treatment repeats every 21 days for 2 courses. Patients undergo surgical resection
of soft tissue disease after course 5 (or after course 6 if medically necessary).

COURSES 4 AND 6: Patients receive cyclophosphamide IV over 6 hours on days 1-2, doxorubicin
hydrochloride IV over 24 hours on days 1-3, vincristine IV on days 1-3, and G-CSF SC or IV
beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21
days for 2 courses.

At end induction, those patients with adequate organ function and peripheral blood stem cell
collection are eligible to undergo randomized assignment to Consolidation therapy.
Randomization is stratified by initial stage of disease, MYCN status, and response to
induction chemotherapy (complete response/very good partial response vs partial response vs
mixed response/no response). Patients are randomized to 1 of 2 arms (single myeloablative
regimen with autologous stem cell support, arm A or tandem (2) myeloablative regimens each
followed by autologous stem cell support, arm B). Patients 12-18 months old (i.e., 365-547
days) with stage IV, MYCN nonamplified tumor with unfavorable histopathology or diploid DNA
content or with indeterminant histology or ploidy AND patients who are greater than 547 days
of age with stage III, MYCN nonamplified tumor AND unfavorable histopathology or
indeterminant histology will be nonrandomly assigned to Arm A.

Consolidation chemotherapy was recommended to begin no later than 8 weeks after the start of
induction course 6.

CONSOLIDATION THERAPY:

ARM A (single myeloablative consolidation): Patients receive melphalan IV over 15-30 minutes
on days -7 to -5, etoposide IV over 24 hours and carboplatin IV over 24 hours on days -7 to
-4, and G-CSF SC or IV beginning on day 0 and continuing until blood counts recover.
Patients undergo autologous peripheral blood stem cell transplant (PBSCT) on day 0.

ARM B (tandem myeloablative consolidation): Patients receive thiotepa IV over 2 hours on
days -7 to -5, cyclophosphamide IV over 1 hour on days -5 to -2, and G-CSF SC or IV
beginning on day 0 and continuing until blood counts recover. Following clinical recovery
from initial myeloablative therapy, patients also receive melphalan, etoposide, and
carboplatin as in Arm A but at reduced dosages. Patients undergo autologous PBSCT on day 0.

RADIOTHERAPY: Patients undergo external beam radiation therapy (EBRT) to primary site of
disease as well as to MIBG-avid sites seen at pre-transplantation (i.e., end- induction)
evaluation no sooner than day 28 and recommended by 42 days post-transplant. An additional
boost of radiotherapy is administered to residual tumor at primary site.

MAINTENANCE THERAPY: Patients are encouraged to enroll onto Children's Oncology Group
(COG)-ANBL0032 following assessment of tumor response after completion of the consolidation
phase and radiotherapy. Beginning on day 60 post-transplantation patients receive oral
isotretinoin twice daily on days 1-14. Treatment repeats every 28 days for up to 6 months in
the absence of disease progression or unacceptable toxicity.

Patients undergo blood and tissue sample collection periodically for the following analyses;
correlation between peak serum concentration level of cyclophosphamide metabolites and the
existence of polymorphisms in genes involved in cyclophosphamide metabolism, event-free
survival, and toxicity rates; pharmacogenomics for uridine diphosphate (UDP)
glucuronosyltransferase 1 family, polypeptide A1 (UGT1A1), UGT2B7, CYP2C8 and CYP3A7
alleles; topotecan systemic clearance; survivin-specific cytotoxic T-lymphocytes (CTLs)
detected using peptide/major histocompatibility complex (MHC) tetramers in human leukocyte
antigen (HLA)-A2+ patients; interferon (IFN)-gamma production in enzyme-linked immunospot
(ELISPOT) assays to APCs loaded with tumor ribonucleic acid (RNA), survivin RNA, or control
RNA; response of APC-stimulated CTL response to neuroblastoma cells; rate of T cell
recovery; and proportion of patients with neuroblastoma detected in bone marrow and
peripheral blood using RT-PCR and immunohistochemistry (IHC).

After completion of study treatment, patients are followed up periodically for 5 years and
then annually for 5 years.

Inclusion Criteria:

- Diagnosis of neuroblastoma or ganglioneuroblastoma by histology or as evidenced by
the presence of clumps of tumor cells in bone marrow and elevated catecholamine
metabolites in urine meeting any of the following criteria:

- Patients with newly diagnosed neuroblastoma with International Neuroblastoma
Staging System (INSS) stage 4 disease are eligible with the following:

- MYCN amplification (i.e., greater than four-fold increase in MYCN signals
as compared to reference signals), regardless of age or additional biologic
features

- Age > 18 months (i.e., > 547 days) regardless of biologic features

- Age 12-18 months (i.e., 365-547 days) with none of the following three
favorable biologic features (i.e., non-amplified MYCN, favorable pathology,
and deoxyribonucleic acid [DNA] index > 1)

- Patients with newly diagnosed neuroblastoma with INSS stage 3 are eligible with
the following:

- MYCN amplification (i.e., greater than four-fold increase in MYCN signals
as compared to reference signals), regardless of age or additional biologic
features

- Age > 18 months (i.e., > 547 days) with unfavorable pathology, regardless
of MYCN status

- Patients with newly diagnosed INSS stage 2a or 2b with MYCN amplification (i.e.,
greater than four-fold increase in MYCN signals as compared to reference
signals), regardless of age or additional biologic features

- Patients with newly diagnosed INSS stage 4s with MYCN amplification (i.e.,
greater than four-fold increase in MYCN signals as compared to reference
signals), regardless of additional biologic features

- Patients >= 365 days initially diagnosed with INSS stage 1, 2, or 4S and who
progressed to a stage 4 without interval chemotherapy

- Must have been enrolled on COG-ANBL00B1

- Creatinine clearance or radioisotope glomerular filtration rate ≥ 70mL/min OR serum
creatinine based on age/gender as follows:

- 1 month to < 6 months: 0.4 mg/dL

- 6 months to < 1 year: 0.5 mg/dL

- 1 to < 2 years: 0.6 mg/dL

- 2 to < 6 years: 0.8 mg/dL

- 6 to < 10 years: 1 mg/dL

- 10 to < 13 years: 1.2 mg/dL

- 10 to < 16 years: 1.5 mg/dL (male), 1.4 mg/dL (female)

- >= 16 years: 1.7 mg/dL (male), 1.4 mg/dL (female)

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) for age

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 10 times ULN for
age

- Not pregnant or nursing

- Negative pregnancy test

- Shortening fraction >= 27% by echocardiogram (ECHO) OR left ventricular ejection
fraction (LVEF) >= 50% by radionuclide angiogram

- No known contraindication (e.g., size, weight or physical condition) to peripheral
blood stem cell collection

- No prior systemic therapy except for localized emergency radiation to sites of
life-threatening or function-threatening disease

- No more than one course of chemotherapy per low- or intermediate-risk neuroblastoma
therapy prior to determination of MYCN amplification and histology
We found this trial at
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Columbia, South Carolina 29203
(803) 434-7000
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Dayton, Ohio 45404
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Denver, CO
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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22101 Moross Rd
Detroit, Michigan 48236
(313) 343-4000
Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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4760 Sunset Blvd
Downey, California 90027
(323) 783-6151
Southern California Permanente Medical Group We
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Duarte, California 91010
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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East Lansing, Michigan 48824
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801 Broadway
Fargo, North Dakota 58102
(701) 234-6175
Sanford Medical Center-Fargo Sanford Medical Center Fargo is a major medical center that provides comprehensive,...
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Myers, FL
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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100 Michigan St NE
Grand Rapids, Michigan 49503
(616) 391-1774
Spectrum Health at Butterworth Campus Butterworth Hospital is one of four facilities that make up...
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Grand Rapids, MI
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835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
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Green Bay, WI
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Greenville, South Carolina 29605
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Children's Hospital Penn State Milton S. Hershey Medical Center, Penn State College...
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1005 Joe DiMaggio Drive
Hollywood, Florida 33021
954-265-JDCH (5324)
Memorial Healthcare System - Joe DiMaggio Children's Hospital Since its inception in 1953, Memorial Healthcare...
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Hollywood, FL
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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Indianapolis, IN
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2001 W 86th St
Indianapolis, Indiana 46260
(317) 338-2345
Saint Vincent Hospital and Health Services At St.Vincent Indianapolis, everything we do begins with a...
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jacksonville, Florida 32207
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