Clinical trial · Interventional

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Infants With Malignant Brain or Spinal Cord Tumors

A Pilot Study of Intensive Chemotherapy With Peripheral Stem Cell Support for Infants With Malignant Brain Tumors

NCT00003141CI-TRIAL-00014128completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctors to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating infants with malignant brain or spinal cord tumors.

Conditions

Conditions (4)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Brain Tumors	Brain Neoplasm	ALIAS	0.90
Central Nervous System Tumors	Central Nervous System Neoplasm	ALIAS	0.90
Neuroblastoma	Neuroblastoma	ONTOLOGY_EXACT	0.90
Sarcoma	Sarcoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (9)

Intervention	Type	Mapped drug	Match
carboplatin	Drug	Carboplatin	ALIAS
cisplatin	Drug	Cisplatin	ALIAS
conventional surgery	Procedure	—	UNRESOLVED
cyclophosphamide	Drug	Cyclophosphamide	ALIAS
etoposide	Drug	Etoposide	ALIAS
filgrastim	Biological	Filgrastim	ALIAS
peripheral blood stem cell transplantation	Procedure	—	UNRESOLVED
thiotepa	Drug	Thiotepa	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Treatment (combination chemotherapy, PBSC transplant)
description
Pts undergo conventional surgery for diagnosis \& max tumor resection. In 6 wks of surgery or when stable pts begin induction chemotherapy(cisplatin IV over 6 hrs on day 0; vincristine sulfate IV on days 0,7,14; cyclophosphamide IV over 1 hr on days 1-2; and etoposide IV over 1 hr on days 0-2. 24 hrs after the last cyclophosphamide dose, pts receive filgrastim (G-CSF) \& undergo peripheral blood stem cell harvest 2 days later. Treatment repeats every 21 days for up to 3 crs. Within 6 wks after induction, pts receive consolidation (carboplatin IV over 2 hrs on days 0-1 next esc. doses of thiotepa IV over 2 hrs. Pts undergo peripheral blood stem cell transplantation 48 hrs after last thiotepa dose. Pts receive G-CSF SC daily on days 3-21. Treatment repeats every 21 days for up to 3 crs. Pts with dose-limiting toxicity due to thiotepa are removed from study. Pts are followed at 4 wks, 3 mths for 1 yr, 6 mths for 3 yrs, annually for 3 yrs or until relapse.
interventionNames
1. Biological: filgrastim
2. Drug: carboplatin
3. Drug: cisplatin
4. Drug: cyclophosphamide
5. Drug: etoposide
6. Drug: thiotepa
7. Drug: vincristine sulfate
8. Procedure: conventional surgery
9. Procedure: peripheral blood stem cell transplantation

Primary outcomes (3)

Eligibility

Eligibility (as posted)

Sex: All
Maximum age: 2 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically proven malignant brain or spinal cord tumor, including the following:

  * Primitive neuroectodermal tumor
  * Ganglioneuroblastoma
  * Medulloblastoma neuroblastoma
  * Desmoplastic medulloblastoma
  * Medulloepithelioma
  * Ependymoma neuroepithelioma
  * Anaplastic ependymoma germ cell tumor
  * Astrocytoma germinoma
  * Anaplastic astrocytoma
  * Embryonal carcinoma
  * Glioblastoma endodermal sinus tumor
  * Gliosarcoma malignant teratoma
  * Choroid plexus carcinoma
  * Mixed germ cell tumor
  * Cerebellar sarcoma
  * Pineoblastoma
  * Atypical teratoid/rhabdoid tumor
  * Choriocarcinoma
  * Teratoma (malignant or with malignant transformations)
* Diffusely involved brain stem tumors allowed if there is evidence of brain stem glioma by CT scan or MRI

PATIENT CHARACTERISTICS:

Age:

* 6 months to less than 3 years

Performance Status:

* Not specified

Life Expectancy:

* More than 8 weeks

Hematopoietic:

* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin less than 2.0 mg/dL

Renal:

* Glomerular filtration rate or creatinine clearance greater than 70 mL/min

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior biologic therapy

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Prior corticosteroids allowed

Radiotherapy:

* No prior radiotherapy

Surgery:

* No more than 6 weeks since prior surgery
* Recovered from prior surgery (stable)

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Mar 1, 1998
Primary completion: Dec 1, 2007
Completion: Oct 1, 2011
First posted: Nov 6, 2003
Last update posted: Mar 28, 2014
Enrollment: 94 (actual)
Lead sponsor: Children's Oncology Group NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: childhood infratentorial ependymoma, childhood supratentorial ependymoma, disseminated neuroblastoma, stage 4S neuroblastoma, embryonal childhood rhabdomyosarcoma, childhood high-grade cerebral astrocytoma, childhood choroid plexus tumor, previously untreated childhood rhabdomyosarcoma, untreated childhood brain stem glioma, untreated childhood supratentorial primitive neuroectodermal tumor, untreated childhood cerebellar astrocytoma, untreated childhood medulloblastoma, newly diagnosed childhood ependymoma, localized resectable neuroblastoma, localized unresectable neuroblastoma, regional neuroblastoma, childhood spinal cord neoplasm, childhood atypical teratoid/rhabdoid tumor, childhood low-grade cerebral astrocytoma, 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

Data updated 22 days agoSource updated Mar 28, 2014source: clinicaltrials