Chemotherapy Followed by Radiation Therapy in Treating Younger Patients With Newly Diagnosed Localized Central Nervous System Germ Cell Tumors



Status:Active, not recruiting
Conditions:Brain Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:3 - 21
Updated:2/10/2019
Start Date:May 29, 2012

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Phase 2 Trial of Response-Based Radiation Therapy for Patients With Localized Central Nervous System Germ Cell Tumors (CNS GCT)

This phase II trial studies how well chemotherapy followed by radiation therapy work in
treating younger patients with newly diagnosed central nervous system germ cell tumors that
have not spread to other parts of the brain, spinal canal, or body (localized). Drugs used as
chemotherapy, such as carboplatin, etoposide, and ifosfamide, work in different ways to stop
the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by
stopping them from spreading. Radiation therapy uses high-energy x rays to kill tumor cells.
Giving chemotherapy followed by radiation therapy may kill more tumor cells.

PRIMARY OBJECTIVES:

I. To determine, as measured by the 3-year progression-free survival (PFS) rate and patterns
of failure, whether dose and volume of irradiation can be safely reduced to 30.6 Gy whole
ventricular-field irradiation (WVI) plus 23.4 Gy primary site boost instead of 36 Gy
craniospinal irradiation (CSI) plus primary site boost in the subgroup of children and young
adults (ages 3 to =< 21 years) with localized nongerminomatous germ cell tumor (NGGCT) who
have a magnetic resonance imaging (MRI) and tumor marker criteria (cerebrospinal fluid [CSF]
and serum) for confirmed complete response (CR) or partial response (PR) to induction
chemotherapy and negative serum and cerebrospinal fluid (CSF) tumor markers OR in patients
who have less than a PR after induction chemotherapy with negative tumor markers who undergo
a second-look surgery and are found to have only mature teratoma, residual scar or fibrosis
and fit the definition of CR/PR after second-look surgery.

II. To determine, as measured by the 3-year PFS rate and patterns of failure, whether
simplified chemotherapy followed by dose-reduced radiation therapy is effective for treating
children and young adults (ages 3 to =< 21 years) with localized primary central nervous
system (CNS) germinoma who present with serum and/or CSF human chorionic gonadotropin-beta
(hCGbeta) =< 50 mIU/mL.

III. To prospectively evaluate and longitudinally model the cognitive, social, and behavioral
functioning of children and young adults who are treated with reduced radiation dose and
volume of irradiation in Stratum 1 (NGGCT) and with dose-reduced radiation therapy in Stratum
2 (germinoma) using the ALTE07C1 protocol.

SECONDARY OBJECTIVES:

I. To estimate the PFS and overall survival (OS) distributions of patients with NGGCT treated
with 30.6 Gy WVI and involved-field radiation therapy (IFR) focal boost to 54 Gy.

II. To estimate the PFS and OS distributions of localized germinoma patients who present with
a) serum and/or CSF hCGbeta =< 50 mIU/mL and b) serum and/or CSF hCGbeta > 50 mIU/mL and =<
100 mIU/mL.

OUTLINE:

STRATUM I (NGGCT): Patients receive induction therapy comprising carboplatin intravenously
(IV) over 15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3 of courses
1, 3, and 5. Patients also receive ifosfamide IV over 60 minutes and etoposide over 60-120
minutes on days 1-5 of courses 2, 4, and 6. Treatment repeats every 21 days for 6 courses in
the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR
undergo 3-dimensional conformal radiation therapy (3DRT) or intensity modulated radiation
therapy (IMRT) once daily (QD) 5 days a week for 6 weeks. Patients with normalization of
markers who fail to achieve CR or PR are strongly recommended to undergo second-look surgery.
Patients who achieve CR or PR after second-look surgery undergo 3DRT or IMRT QD 5 days a week
for 6 weeks.

STRATUM II (GERMINOMA): Patients receive induction therapy comprising carboplatin IV over
15-60 minutes on day 1 and etoposide IV over 60-120 minutes on days 1-3. Treatment repeats
every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Patients with CR or continued CR (CCR) undergo 3DRT or IMRT QD 5 days a week for 4 weeks.
Patients with normalization of markers who fail to achieve CR or PR are strongly recommended
to undergo second-look surgery. Patients found to have fibrosis, scar, mature teratoma, or
non-viable tumor undergo 3DRT or IMRT QD 5 days a week for 4 weeks. Patients with stable
disease (SD) or PR with > 0.5 cm (suprasellar) or > 1 cm (pineal) but =< 1.5 cm residual
disease do not undergo second-look surgery and undergo 3DRT or IMRT QD 5 days a week for 4
weeks.

After completion of study treatment, patients are followed up at 3, 6, and 9 months, every 4
months for 24 months, 30 months, and then annually for up to 60 months.

Inclusion Criteria:

- Patients must be newly diagnosed with localized primary CNS NGGCT (Stratum 1) or
localized primary CNS germinoma (Stratum 2); germ cell tumors located in the
suprasellar, pineal, bifocal (pineal + suprasellar) and ventricles are eligible;
tumors present in the above mentioned locations and with unifocal parenchymal
extension are eligible

- Stratum 1(NGGCT): Patients must have one of the following criteria:

- Patients with serum and/or CSF hCGbeta > 100 mIU/mL or any elevation of
serum and/or CSF alpha-fetoprotein (AFP) > 10 ng/mL or greater than the
institutional normal are eligible, irrespective of biopsy results

- Patients with any of the following elements on biopsy/resection are
eligible, irrespective of serum and/or CSF hCGbeta and AFP levels:
endodermal sinus tumor (yolk sac), embryonal carcinoma, choriocarcinoma,
malignant/immature teratoma, and mixed GCT with malignant GCT elements

- Stratum 2 (Germinoma): Patients must have both serum and CSF markers obtained
(unless obtaining CSF is medically contraindicated) and must have one of the
following criteria to be eligible:

- Patients with institutional normal AFP (or =< 10 ng/mL if no institutional
normal exists) in both serum and CSF (unless medically contraindicated) AND
hCGbeta 5 to =< 50 mIU/mL in serum and/or CSF (unless medically
contraindicated) (only 1 is required to be elevated) are eligible; no
histologic confirmation required

- Patients with bifocal (pineal + suprasellar) involvement or pineal lesion
with diabetes insipidus (D1) AND hCGbeta =< 100 mIU/mL in serum and/or CSF
AND institutional normal AFP (or =< 10 ng/mL if no institutional normal
exists) in both serum and CSF (unless medically contraindicated) are
eligible; no histologic confirmation required

- Patients with histologically confirmed germinoma or germinoma mixed with
mature teratoma and hCGbeta =< 100 mIU/mL in serum and/or CSF and
institutional normal AFP (or =< 10 ng/mL if no institutional normal exists)
in both serum and CSF (unless medically contraindicated) are eligible

- All patients must have a cranial MRI with and without gadolinium at diagnosis/prior to
enrollment; if surgical resection is performed, patients must have pre-operative and
post-operative cranial MRI with and without gadolinium; the post-operative brain MRI
should be obtained within 72 hours of surgery; if patient has a biopsy only,
post-operative cranial MRI is recommended but not required; all patients must have a
spine MRI with gadolinium obtained at diagnosis/prior to enrollment; Note: if the
spine study is performed for the first time after surgical resection or biopsy, it is
recommended to be obtained with and without gadolinium

- Lumbar CSF must be obtained prior to study enrollment unless medically
contraindicated; if a patient undergoes surgery and lumbar CSF cannot be obtained at
this time, then it should be performed at least 10 days following surgery before study
enrollment; false positive cytology can occur within 10 days of surgery; Note:
patients with positive CSF cytology obtained prior to 10 days after surgery may have
cytology repeated to determine eligibility

- Patients must have CSF tumor markers obtained prior to enrollment unless medically
contraindicated; ventricular CSF obtained at the time of CSF diversion procedure (if
performed) is acceptable for tumor markers but lumbar CSF is preferred; in case CSF
diversion and biopsy/surgery are combined, CSF tumor markers should be collected first

- Patients must be enrolled on ALTE07C1 prior to enrollment on ACNS1123; patients must
be enrolled within 31 days of definitive diagnostic surgery (day 0) or clinical
diagnosis

- Peripheral absolute neutrophil count (ANC) >= 1,000/uL

- Platelet count >= 100,000/uL (transfusion independent)

- Hemoglobin >= 8.0 g/dL (may receive red blood cell [RBC] transfusions)

- Creatinine clearance or radioisotope glomular filtration rate (GFR) >= 70 mL/min/1.73
m^2 OR serum creatinine based on age/gender as follows:

- 0.8 mg/dL (2 to < 6 years of age)

- 1.0 mg/dL (6 to < 10 years of age)

- 1.2 mg/dL (10 to < 13 years of age)

- 1.5 mg/dL (male) and 1.4 mg/dL (female) (13 to < 16 years of age)

- 1.7 mg/dL (male) and 1.4 mg/dL (female) (>= 16 years of age)

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

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5
times ULN

- Patients with seizure disorder may be enrolled if well controlled

- Patients must not be in status, coma, or assisted ventilation prior to study
enrollment

Exclusion Criteria:

- Patients with mature teratoma or completely resected immature teratoma with normal
tumor markers are not eligible

- Patients with tumors located outside the ventricles (basal ganglia, thalamus) are not
eligible

- Patients with metastatic disease by cranial or spinal MRI evaluation or CSF cytology
(unless medically contraindicated) are not eligible

- Patients must not have received any prior tumor-directed therapy other than surgical
intervention and corticosteroids

- Female patients who are pregnant are ineligible

- Lactating females are not eligible unless they have agreed not to breastfeed their
infants

- Female patients of childbearing potential are not eligible unless a negative pregnancy
test result has been obtained

- Sexually active patients of reproductive potential are not eligible unless they have
agreed to use an effective contraceptive method for the duration of their study
participation

- All patients and/or their parents or legal guardians must sign a written informed
consent

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
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Greenville, South Carolina 29605
(864)455-8898
Principal Investigator: Nichole L. Bryant
Phone: 864-241-6251
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Greenville, South Carolina 29605
Principal Investigator: Nichole L. Bryant
Phone: 864-241-6251
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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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Hershey, Pennsylvania 17033
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Honolulu, Hawaii 96813
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1319 Punahou St
Honolulu, Hawaii 96826
(808) 983-6000
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Houston, TX
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Houston, Texas 77030
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Hunter Regional Mail Centre, New South Wales
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Robert J. Fallon
Phone: 317-274-2552
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, Indiana 46260
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Jacksonville, Florida 32207
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
Principal Investigator: Ray C. Pais
Phone: 865-541-8266
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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Las Vegas, Nevada 89144
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Los Angeles, California 90095
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Louisville, Kentucky 40202
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Lubbock, Texas 79430
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Madera, California 93638
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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