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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
Not Recruiting
Trial ID: NCT00047320
Purpose
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.
Official Title
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
Stanford Investigator(s)
Eligibility
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
Intervention(s):
radiation: radiation therapy
drug: carboplatin
drug: etoposide
drug: ifosfamide
drug: thiotepa
procedure: adjuvant therapy
procedure: conventional surgery
procedure: neoadjuvant therapy
procedure: peripheral blood stem cell transplantation
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Peds Hem/Onc CRAs
650-723-5535