Know Cancer

or
forgot password

Treatment of Newly Diagnosed Medulloblastoma and Supratentorial PNET in Patients At Least 3 Years With a Phase II Topotecan Window (High-Risk Patients Only), Risk-Adapted Radiation Therapy, and Dose-Intensive Chemotherapy With Peripheral Blood Stem Cell Support


Phase 2
3 Years
20 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Treatment of Newly Diagnosed Medulloblastoma and Supratentorial PNET in Patients At Least 3 Years With a Phase II Topotecan Window (High-Risk Patients Only), Risk-Adapted Radiation Therapy, and Dose-Intensive Chemotherapy With Peripheral Blood Stem Cell Support


OBJECTIVES:

- Estimate the response rate to topotecan in children with newly diagnosed
medulloblastoma or supratentorial primitive neuroectodermal tumors who have measurable
residual disease after surgery. (Topotecan window closed to accrual 9/10/2001)

- Determine the feasibility of four courses of high-dose chemotherapy (vincristine,
cisplatin, and cyclophosphamide) with peripheral blood stem cell support after
craniospinal irradiation (CSI) in these patients.

- Estimate the 5-year overall survival and progression-free survival in patients treated
with risk-adapted CSI and high-dose chemotherapy.

- Compare changes in intellectual functioning in patients treated with reduced-dose vs
standard-dose CSI.

- Estimate the incidence of ototoxicity associated with risk-adapted CSI and posterior
fossa boost(s) given by 3-D conformal radiotherapy technique combined with amifostine
and cisplatin.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups based
on risk status.

- Group 1 (average-risk): Patients receive filgrastim (G-CSF) subcutaneously (SC) or IV
daily until peripheral blood stem cells (PBSC) are harvested. PBSC are harvested when
blood counts recover. Patients then receive craniospinal irradiation (CSI) 5 days a
week for 6 weeks. Beginning 6 weeks after completion of CSI, patients receive high-dose
chemotherapy comprising vincristine IV followed by cisplatin IV over 6 hours on day -4
and cyclophosphamide IV over 1 hour on days -3 and -2. Patients receive amifostine IV
over 1 minute a maximum of 5 minutes prior to cisplatin infusion and then 3 hours into
cisplatin infusion. PBSC are reinfused on day 0. Patients receive G-CSF SC beginning on
day 1 and continuing for a minimum of 7 days or until blood counts recover. Vincristine
IV is administered on day 6. G-CSF is stopped 48 hours prior to beginning subsequent
courses of chemotherapy. High-dose chemotherapy repeats every 4 weeks for 4 courses.

- Group 2 (high-risk): Patients receive topotecan IV over 4 hours on days 1-5 and G-CSF
SC or IV beginning 24 hours after completion of the first course of topotecan and
continuing until PBSC are harvested. Treatment repeats every 3 weeks for 2 courses. If
an adequate number of PBSC are not harvested, the patient undergoes a second harvest of
PBSC after the second course of topotecan. Patients then receive CSI, high-dose
chemotherapy, amifostine, and PBSC support as in group 1. (Topotecan window closed to
accrual 9/10/2001) Patients undergo neuropsychological testing prior to radiotherapy
and chemotherapy and then at 1, 2, and 5 years.

Patients are followed at 1, 2, 4, 6, 9, 12, 15, 18, and 24 months and then every 6 months
for 3 years.

PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven medulloblastoma or supratentorial primitive neuroectodermal
tumor

- Average-risk group:

- Localized tumor with no overt evidence of invasion beyond the posterior fossa

- Less than 1.5 cm2 residual tumor/imaging abnormality

- No CNS or extraneural metastasis (confirmed by bone scan)

- Brain stem invasion allowed if above criteria met

- High-risk group:

- Metastatic disease within the neuraxis (subarachnoid dissemination) OR greater
than 1.5 cm^2 residual disease at the primary site after surgery

- No bone involvement by bone scan

- Must begin study within 28 days of definitive surgery

PATIENT CHARACTERISTICS:

Age

- 3 to 20 at diagnosis

Performance status

- ECOG 0-3 (except patients with posterior fossa syndrome)

Life expectancy

- Not specified

Hematopoietic

- WBC greater than 3,000/mm^3

- Absolute neutrophil count greater than 1,500/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 10 g/dL

Hepatic

- Bilirubin less than 1.5 mg/dL

- SGPT less than 1.5 times normal

Renal

- Creatinine less than 1.2 mg/dL OR

- Creatinine clearance greater than 70 mL/min

Other

- Not pregnant or nursing

- Negative pregnancy test

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Prior corticosteroids allowed

Radiotherapy

- No prior radiotherapy

Surgery

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Principal Investigator

Amar Gajjar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000066069

NCT ID:

NCT00003211

Start Date:

October 1996

Completion Date:

June 2007

Related Keywords:

  • Brain and Central Nervous System Tumors
  • untreated childhood supratentorial primitive neuroectodermal tumor
  • untreated childhood medulloblastoma
  • Medulloblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Texas Children's Cancer CenterHouston, Texas  77030-2399