Neoadjuvant Chemotherapy With or Without Second-Look Surgery Followed by Radiation Therapy With or Without Peripheral Stem Cell Transplantation in Treating Patients With Intracranial Germ Cell Tumors



Status:Completed
Conditions:Cancer, Brain Cancer, Brain Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:3 - 24
Updated:2/16/2018
Start Date:January 2004
End Date:February 2009

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A Phase II Study To Assess The Ability Of Neoadjuvant Chemotherapy Plus/Minus Second Look Surgery To Eliminate All Measurable Disease Prior To Radiotherapy For NGGCT

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from
dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink
the tumor so that it is no longer present by conventional imaging and tumor markers from
serum and cerebrospinal fluid. Radiation therapy uses high-energy x-rays to damage tumor
cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of
chemotherapy drugs and kill more tumor cells. Combining different types of therapy may kill
more tumor cells.

PURPOSE: This Phase II trial is studying how well neoadjuvant chemotherapy with or without
surgery and with or without high dose chemotherapy and peripheral stem cell transplantation,
can increase response rates prior to radiation therapy and increase progression free and
overall surviving patients with newly diagnosed intracranial germ cell tumors.

OBJECTIVES:

- Determine the response rate of patients with non-germinomatous germ cell tumors treated
with neoadjuvant chemotherapy.

- Determine the progression-free survival and overall survival of patients treated with
neoadjuvant chemotherapy with or without second-look surgery followed by radiotherapy
with or without autologous peripheral blood stem cell transplantation (PBSCT).

- Determine whether additional complete responses can be achieved after high-dose thiotepa
and etoposide with PBSCT in patients with persistently positive markers, histological
evidence of residual malignant elements, or unresectable residual tumors after initial
neoadjuvant chemotherapy.

- Determine patterns of recurrence in patients treated with this regimen.

- Correlate tumor marker response with radiographic and clinical measures of response, as
well as findings at second-look surgery in patients with radiological evidence of
residual disease.

OUTLINE:

- Induction chemotherapy:

- Courses 1, 3, and 5: Patients receive carboplatin IV over 1 hour on day 1 and
etoposide IV over 1 hour on days 1-3. Beginning on day 4, patients receive
filgrastim (G-CSF) IV or subcutaneously (SC) for 10 days or until blood counts
recover. Courses are 3 weeks in duration.

- Courses 2, 4, and 6: Patients receive etoposide IV over 1 hour followed by
ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive G-CSF
IV or SC for 10 days or until blood counts recover. Courses are 3 weeks in
duration.

Patients undergo re-evaluation. Patients with a complete response (CR) go directly to
radiotherapy. Approximately 3 weeks after completion of induction chemotherapy, all patients
with less than a CR are encouraged to undergo second-look surgery.

After second-look surgery, patients with a CR or a partial response (PR) go directly to
radiotherapy. Patients with less than a PR undergo consolidation chemotherapy with peripheral
blood stem cell rescue (PBSC) followed by radiotherapy.

- Consolidation chemotherapy: Patients undergo PBSC collection. Patients receive G-CSF SC
until PBSC collection is complete. Patients then receive thiotepa IV over 3 hours
followed by etoposide IV over 3 hours on days -5 to -3. PBSCs are reinfused on day 0.
Beginning on day 1 and continuing until blood counts recover, patients receive G-CSF SC
daily.

- Radiotherapy: All patients receive radiotherapy once daily 5 days a week for 5-6 weeks
beginning after recovery from induction chemotherapy or second-look surgery or within 9
weeks after PBSC reinfusion.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 80-100 patients will be accrued for this study within 36-42
months.

DISEASE CHARACTERISTICS:

- One of the following diagnoses:

- Histologically confirmed intracranial non-germinomatous germ cell tumor (NGGCT)
of 1 of the following types:

- Endodermal sinus tumor (yolk sac tumor)

- Embryonal carcinoma

- Choriocarcinoma

- Immature teratoma and teratoma with malignant transformation

- Mixed germ cell tumor

- Histologically confirmed germinoma with elevation of serum/CSF beta human
chorionic gonadotropin (HCG) levels greater than 50 mIU/mL or any serum/CSF
alpha-fetoprotein (AFP) levels greater than 10 ng/ml or above institutional norm

- Histologically unconfirmed pineal and/or suprasellar tumors with serum/CSF beta
HCG levels greater than 50 mIU/mL or AFP levels greater than 10 ng/ml or above
institutional norm

- Patients with normal AFP and beta HCG < 50 mIU/mL without histologic diagnosis of a
NGGCT or patients with pure germinoma without elevation of tumor marker are ineligible

- Initial diagnosis within the past 31 days

PATIENT CHARACTERISTICS:

Age

- 3 to 24 at diagnosis

Performance status

- No minimum performance level

Life expectancy

- At least 8 weeks

Hematopoietic

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3 (transfusion independent)

- Hemoglobin at least 10.0 g/dL (transfusion allowed)

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- ALT no greater than 2.5 times ULN

Renal

- Creatinine no greater than 1.5 times ULN OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Pulmonary

- No assisted ventilation

Other

- Seizure disorders allowed

- No patients in status or coma

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patient must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Prior corticosteroids allowed

- Concurrent corticosteroids allowed

- Concurrent endocrine replacement therapy allowed (e.g., L-thyroxine, testosterone,
estrogen, desmopressin acetate)

- No concurrent growth hormone therapy

Radiotherapy

- Not specified

Surgery

- More than 1 prior surgery allowed

Other

- No other prior therapy for malignancy
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Sacramento, California 95816
365
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1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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Akron, OH
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
651
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Albuquerque, NM
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4900 Mueller Boulevard
Austin, Texas 78723
(512) 324-0000
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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Austin, TX
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Baltimore, Maryland 21231
410-955-6190
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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Baltimore, MD
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800 Washington St # 314
Boston, Massachusetts 02111
2578
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Boston, MA
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1300 Morris Park Avenue
Bronx, New York 10461
718.430.2302
Albert Einstein Cancer Center at Albert Einstein College of Medicine The Albert Einstein Cancer Center...
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Bronx, NY
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
(843) 792-0700
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2184
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1025 Morehead Medical Dr # 600
Charlotte, North Carolina 28204
(704) 355-2884
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2102
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Charlotte, NC
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
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1880
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Cincinnati, OH
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2010 E 90th St
Cleveland, Ohio 44195
(866) 223-8100
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2033
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700 Childrens Drive
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1961
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Columbus, OH
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3533 South Alameda Street
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(361) 694-5000
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4100 John R
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125 Science Dr
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1545 Airport Boulevard
Pensacola, Florida 32504
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Philadelphia, Pennsylvania 19134
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South 34th Street
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100 N Mario Capecchi Dr
Salt Lake City, Utah 84132
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San Antonio, Texas 78229
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3020 Childrens way
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750 E Adams St
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3001 W Dr Martin L King Jr
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40 Sunshine Cottage Road
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West Palm Beach, Florida 33407
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Wilmington, Delaware 19803
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1365 Clifton Rd NE
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3110 MacCorkle Ave. S.E.
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225 E Chicago Ave
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535 Barnhill Dr
Indianapolis, Indiana 46202
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Kansas City, Kansas 66160
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4018 W Capitol Ave.
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1000 N Oak Ave
Marshfield, Wisconsin 54449
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Milwaukee, Wisconsin 53226
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2525 Chicago Ave
Minneapolis, Minnesota 55404
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195 Little Albany St
New Brunswick, New Jersey 08903
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160 E 34th St
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201 Lyons Ave
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1919 E Thomas Rd
Phoenix, Arizona 85006
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Pittsburgh, Pennsylvania 15213
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200 First Street SW
Rochester, Minnesota 55905
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Saint Petersburg, Florida 33701
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Sioux Falls, South Dakota 57117
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315 West Carpenter Street
Springfield, Illinois 62794
217.545.8000
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Stanford, California 94305
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111 Michigan Ave NW
Washington, District of Columbia
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