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An Intergroup Pilot Study of Concurrent Carboplatin, Vincristine and Radiotherapy Followed by Adjuvant Chemotherapy in Patients With Newly Diagnosed High-Risk Central Nervous System Embryonal Tumors


Phase 2
3 Years
21 Years
Not Enrolling
Both
Brain and Central Nervous System Tumors, Neuroblastoma

Thank you

Trial Information

An Intergroup Pilot Study of Concurrent Carboplatin, Vincristine and Radiotherapy Followed by Adjuvant Chemotherapy in Patients With Newly Diagnosed High-Risk Central Nervous System Embryonal Tumors


OBJECTIVES:

- Determine the feasible dose and duration of carboplatin combined with craniospinal and
local radiotherapy and adjuvant chemotherapy in children with newly diagnosed,
high-risk CNS embryonal tumors (Phase I completed as of 11-25-03).

- Determine the feasibility of administering cyclophosphamide and vincristine with or
without cisplatin after concurrent carboplatin, vincristine, and radiotherapy in these
patients.

- Determine the overall and individual toxicity rates of this regimen in these patients.

- Determine the complete response rate in patients treated with this regimen.

- Obtain preliminary estimates of event-free survival of patients treated with this
regimen.

- Determine the prognostic significance of enhancing tumor after completion of
radiotherapy on event-free survival of these patients.

OUTLINE: This is a pilot, dose-escalation study of carboplatin. (Phase I completed as of
11-25-03.)

Within 31 days of definitive surgery, all patients receive vincristine IV weekly for 6 weeks
and carboplatin IV over 15-20 minutes (after completion of vincristine infusion) 5 days a
week for 6 weeks. Patients undergo radiotherapy (1-4 hours after carboplatin infusion) 5
days a week for 6 weeks.

Cohorts of 6-12 patients receive escalating doses of carboplatin until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which no more than 3 of 12
patients experience dose-limiting toxicity. (Phase I completed as of 11-25-03.)

At 6 weeks after completion of radiotherapy, patients are assigned to arm II for
adjuvant/maintenance chemotherapy. (Arm I closed to accrual as of 11-25-03.)

- Arm I (closed to accrual as of 11-25-03): Patients receive cyclophosphamide IV over 1
hour on days 0 and 1, vincristine IV on days 0 and 7, and filgrastim (G-CSF) IV or
subcutaneously (SC) beginning on day 2 and continuing for at least 10 days until blood
counts recover.

- Arm II: Patients receive cyclophosphamide IV over 1 hour on days 1 and 2, vincristine
IV on days 0 and 7, cisplatin IV over 6 hours on day 0, and G-CSF IV or SC beginning on
day 3 and continuing for at least 10 days until blood counts recover.

In both arms, adjuvant/maintenance chemotherapy repeats every 4 weeks for 6 courses.

Patients are followed every 3 months for 8 months, every 4 months for 1 year, every 6 months
for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 162 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven high-risk CNS embryonal tumors, including:

- Primitive neuroectodermal tumors

- Atypical teratoid/rhabdoid tumor

- Medulloblastoma

- Desmoplastic medulloblastoma

- Ependymoblastoma

- Medullomyoblastoma

- Spongioblastoma

- Spongioblastoma polare

- Primitive polar spongioblastoma

- Neuroepitheliomatous neoplasms

- Medulloepithelioma

- Neuroblastoma

- Pineoblastoma

- No bone marrow involvement or bone metastases

- No M4 disease

- M3 disease must have evidence of tumor on spinal MRI

PATIENT CHARACTERISTICS:

Age:

- 3 to 21 at diagnosis

Performance status:

- Not specified

Life expectancy:

- At least 8 weeks

Hematopoietic:

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

- Platelet count at least 100,000/mm^3 (transfusion independent)

- Hemoglobin at least 10.0 g/dL (packed red blood cell transfusions allowed)

Hepatic:

- Bilirubin less than 1.5 mg/dL

- SGOT/SGPT less than 2.5 times normal

Renal:

- Creatinine less than 1.5 times upper limit of normal OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy

Surgery:

- Prior definitive surgery allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Regina Jakacki, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital of Pittsburgh of UPMC

Authority:

United States: Federal Government

Study ID:

CDR0000066055

NCT ID:

NCT00003203

Start Date:

March 1998

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Neuroblastoma
  • untreated childhood supratentorial primitive neuroectodermal tumor
  • untreated childhood medulloblastoma
  • localized unresectable neuroblastoma
  • regional neuroblastoma
  • stage 4S neuroblastoma
  • Carcinoma, Embryonal
  • Nervous System Neoplasms
  • Neuroblastoma
  • Central Nervous System Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Ireland Cancer CenterCleveland, Ohio  44106-5065
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - KalamazooKalamazoo, Michigan  49007-3731
Vanderbilt Cancer CenterNashville, Tennessee  37232-6838
CCOP - Merit Care HospitalFargo, North Dakota  58122
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Huntsman Cancer InstituteSalt Lake City, Utah  84112
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Long Beach Memorial Medical CenterLong Beach, California  90806
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105