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Protocol for the Treatment of Extracranial Germ Cell Tumours in Children and Adolescents (GC III)


Phase 3
N/A
17 Years
Open (Enrolling)
Both
Childhood Germ Cell Tumor, Extragonadal Germ Cell Tumor, Ovarian Cancer

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Trial Information

Protocol for the Treatment of Extracranial Germ Cell Tumours in Children and Adolescents (GC III)


OBJECTIVES:

- Stratify and reduce treatment for pediatric patients with extracranial germ cell tumors
while maintaining event-free survival.

- Treat newly diagnosed patients with extracranial germ cell tumors requiring
chemotherapy with a carboplatin-based strategy.

- Develop a common strategy for the treatment of patients with recurrent or progressive
extracranial germ cell tumors.

- Register all cases of mature and immature teratoma.

- Develop a common strategy for the management of immature and mature teratoma, including
follow-up strategies to permit early detection of yolk sac recurrence.

OUTLINE: This is a multicenter study.

Patients who have not had prior biopsy or surgical resection undergo biopsy (if feasible) or
surgical resection. Patients with mature or immature teratoma undergo observation. These
patients who relapse (i.e., tumor regrowth) may undergo further surgical resection unless
tumor markers are significantly elevated. If the tumor markers are significantly elevated,
these patients proceed to JEB chemotherapy according to risk group. Patients with all other
malignant germ cell tumors are assigned to 1 of 3 treatment groups according to risk.

- Low-risk group: Patients with normal tumor markers undergo observation. Patients with
rising tumor markers only AND no imageable tumor proceed to treatment as in the
intermediate-risk group. Patients with rising tumor markers AND/OR imageable tumor are
considered to have relapsed and proceed to treatment as in the intermediate- or
high-risk group.

- Intermediate-risk group: Patients receive JEB chemotherapy comprising etoposide IV over
4 hours on days 1-3, carboplatin IV over 1 hour on day 2, and bleomycin IV over 30
minutes on day 3. Treatment repeats every 21 days for 4 courses. Patients with residual
tumors after completion of chemotherapy may undergo second-look surgery.

- High-risk group: Patients receive JEB chemotherapy as in the intermediate-risk group
for 6 courses. Patients with residual tumors after completion of chemotherapy may
undergo second-look surgery.

- Relapse therapy: Patients in the intermediate- or high-risk group who relapse after
completion of JEB chemotherapy receive vinblastine IV on days 1 and 2, ifosfamide IV
over 1 hour on days 1-5, and cisplatin IV on days 1-5. Treatment repeats every 21 days
for 6 courses.

PROJECTED ACCRUAL: A total of 105 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically* proven extracranial malignant germ cell tumor (GCT), including
mature/immature teratoma, with or without elevated alpha-fetoprotein (AFP) or human
chorionic gonadotropin (HCG) levels

- Newly diagnosed disease

- Patients with relapsed or progressive extracranial malignant GCT allowed if
previously treated with carboplatin, etoposide, and bleomycin (JEB) chemotherapy

- Patients relapsing following JEB are eligible for the study relapse
strategy NOTE: *Patients with unequivocally raised AFP/HCG whose risk of
biopsy is felt to be high can be diagnosed by clinical grounds, imaging,
and markers

- No intracranial GCTs

PATIENT CHARACTERISTICS:

- Neutrophil count ≥ 1,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 2 times upper limit of normal (ULN)

- ALT ≤ 3 times ULN

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- No prior chemotherapy other than JEB

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Safety Issue:

No

Principal Investigator

Juliet Hale, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sir James Spence Institute of Child Health at Royal Victoria Infirmary

Authority:

United States: Federal Government

Study ID:

CDR0000454553

NCT ID:

NCT00274950

Start Date:

May 2005

Completion Date:

Related Keywords:

  • Childhood Germ Cell Tumor
  • Extragonadal Germ Cell Tumor
  • Ovarian Cancer
  • childhood extragonadal germ cell tumor
  • childhood malignant ovarian germ cell tumor
  • childhood malignant testicular germ cell tumor
  • recurrent childhood malignant germ cell tumor
  • childhood teratoma
  • childhood extracranial germ cell tumor
  • Ovarian Neoplasms
  • Neoplasms, Germ Cell and Embryonal

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