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

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