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Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies


Phase 2
3 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Pediatric Germ Cell Tumor, Extragonadal Germ Cell Tumor

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Trial Information

Phase II Pre-Irradiation Chemotherapy for Central Nervous System Germ Cell Malignancies


OBJECTIVES:

- Determine the response rate of patients with newly diagnosed CNS germ cell tumors
treated with cisplatin and etoposide.

- Determine the survival of patients with CNS germ cell tumors treated with cisplatin and
etoposide followed by cranial radiotherapy.

- Determine endocrine and cognitive function in these patients before and after receiving
this regimen.

OUTLINE: Patients are stratified by histology (germinoma vs nongerminoma).

Patients receive cisplatin IV over 4 hours followed by etoposide IV over 30-60 minutes on
days 1-5. Treatment continues every 3 weeks for 4 courses in the absence of disease
progression or unacceptable toxicity. After completion of 4 courses, patients with
nongerminoma who achieve complete response (CR) and all patients with germinoma proceed to
radiotherapy. After completion of 4 courses, patients with nongerminoma who achieve less
than CR undergo resection of any residual cranial masses, if feasible, and then proceed to
radiotherapy. Patients who experience disease progression or unacceptable toxicity during
chemotherapy are restaged and proceed directly to radiotherapy.

Beginning a minimum of 3 weeks after completion of the last course of chemotherapy and after
recovering from any toxic effects of chemotherapy, eligible patients undergo a regimen of
craniospinal axis irradiation and/or localized cranial or spinal field irradiation based on
histology, extent of disease, and response to chemotherapy. Patients with gross spinal
meningeal disease after completion of chemotherapy undergo radiotherapy boost.

Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months
for 1 year, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 12-25 patients with germinoma will be accrued for this study
within 3-6 years. A total of 12-25 patients with nongerminoma will be accrued for this study
within 6-12 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven CNS germ cell tumor of 1 of the following subtypes:

- CNS germinoma

- Immature teratoma

- Embryonal cell carcinoma

- Yolk sac tumor

- Endodermal sinus tumor

- Choriocarcinoma OR

- Pineal or suprasellar mass associated with elevated CSF alpha fetoprotein or
beta-human chorionic gonadotropin allowed

- Patients 18 years and over with localized pure germinomas ineligible

- Evaluable CT or MRI of brain and/or spinal cord required

PATIENT CHARACTERISTICS:

Age:

- 3 and over

Hematopoietic:

- Age 18 and over:

- WBC at least 4,000/mm^3

- Platelet count at least 100,000/mm^3

- Under age 18:

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

- Platelet count at least 100,000/mm^3

Hepatic:

- Not specified

Renal:

- Creatinine no greater than 0.3 mg/dL above upper limit of normal for age

Other:

- No uncontrolled infection

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for CNS germ cell tumor

Endocrine therapy:

- Concurrent corticosteroids allowed except as antiemetics

Radiotherapy:

- No prior cranial or spinal radiotherapy

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Jan C. Buckner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Federal Government

Study ID:

CDR0000076756

NCT ID:

NCT00002472

Start Date:

March 1991

Completion Date:

August 2005

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Pediatric Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • childhood central nervous system germ cell tumor
  • extragonadal germ cell tumor
  • adult central nervous system germ cell tumor
  • childhood teratoma
  • childhood central nervous system choriocarcinoma
  • childhood central nervous system embryonal tumor
  • childhood central nervous system germinoma
  • childhood central nervous system mixed germ cell tumor
  • childhood central nervous system teratoma
  • childhood central nervous system yolk sac tumor
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905