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Clinical Trials (PDQ®)

  • First Published: 8/1/1998
  • Last Modified: 4/1/1999

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Clinical Trials (PDQ®)

Phase II Study of Marrow Ablative Chemotherapy Followed by Rescue with Peripheral Blood Stem Cells, Radiotherapy, and Isotretinoin in Patients with High Risk Neuroblastoma (Summary Last Modified 04/1999)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Alternate Title

Chemotherapy, Peripheral Stem Cell Transplantation, and Radiation Therapy in Treating Children With High-Risk Neuroblastoma

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedUnder 21NCIPOG-9640

Objectives

I.  Determine the response rates and overall survival of patients with high 
risk neuroblastoma following treatment with high dose cisplatin, vincristine, 
etoposide, cyclophosphamide, doxorubicin, ifosfamide, and carboplatin followed 
by autologous stem cell transplantation and radiation therapy.

II.  Determine the side effects, short and long term, of the treatment in 
these patients.

III.  Assess the relationship of biological features of neuroblastoma as 
determined on protocol POG-9047, to clinical presentation, response to 
therapy, and survival.

Entry Criteria

Disease Characteristics:


Histologically confirmed high risk neuroblastoma
 - Newly diagnosed high risk neuroblastoma patients previously registered no
    more than 2 weeks earlier on POG-9047 or its successor
 - Newly diagnosed high risk neuroblastoma patients who have received one
    course of chemotherapy on POG-9641 or A3961
 - Relapsed or progressive neuroblastoma patients previously enrolled on POG
    9641 who have received NO prior chemotherapy or radiotherapy and were
    originally low risk at diagnosis, who at relapse are high risk
      May not register on this protocol more than one time

High risk neuroblastoma including:
 Stage IIA or IIB, older than 365 days of age with N-myc amplified,
  unfavorable histology with any ploidy
 Stage III under 365 days of age with N-myc amplification
 Stage III older than 365 days with N-myc amplification or with nonamplified
  N-myc but unfavorable histology
 Stage IV under 365 days of age with N-myc amplification
 Stage IV over 365 days of age regardless of N-myc or histology
 Stage IVS with N-myc amplification


Prior/Concurrent Therapy:


See Disease Characteristics


Patient Characteristics:


Age:
 See Disease Characteristics

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Expected Enrollment

There will be 30 patients accrued into this study in 1.5 years.

Outline

Patients are stratified by disease status.

Patients receive the following five 21-day courses of induction chemotherapy:
 Course 1 (week 0) - Cisplatin IV over 1 hour every day for 5 days and
  etoposide IV over 1 hour every 12 hours for 6 doses beginning just prior to
  cisplatin on day 2.  
 Course 2 (week 3) -  Vincristine IV push on days 1, 8, and 15, doxorubicin IV
  over 1 hour on day 1, and cyclophosphamide IV over 1 hour after doxorubicin
  on day 1 and again on day 2. 
 Course 3 (week 6) -  Etoposide IV over 1 hour every 12 hours for 3 days and
  ifosfamide IV over 1 hour days 1-5.  
 Course 4 (week 9) -  Etoposide IV over 1 hour every 12 hours for 3 days,
  carboplatin IV over 5 hours after etoposide on days 1 and 2.
 Course 5 (week 12) -  High dose cisplatin and etoposide as in course 1. 

Patients are assessed for disease response after the third and fifth courses 
of treatment.  If there is tumor response, patients undergo surgery 3 weeks 
after completion of induction chemotherapy.

Patients not eligible for stem cell transplantation receive postinduction 
chemotherapy consisting of induction therapy courses, except in a different 
order: course 3, course 2, course 1, course 2, and course 4.

After recovery from the last course of chemotherapy, patients undergo ablation 
chemotherapy.  Patients receive etoposide by continuous IV infusion over 72 
hours on days -6 through -4, carboplatin IV over 1 hour each day for three 
days on days -6 to -4, and cyclophosphamide IV over 1 hour each day for 2 
days.  On day 0, patients receive peripheral blood stem cell (PBSC) infusion.  
Patients then receive filgrastim (G-CSF) IV daily until absolute neutrophil 
count is greater than 1,000/mm3 for 2 days.  The second course of ablation 
therapy consists of thiotepa IV over 2 hours on days -6 to -4 and 
cyclophosphamide IV over 1 hour every 8 hours for 12 doses on days -4 to -1.  
PBSC infusion occurs on day 0.  G-CSF begins on day 3.

Following ablation chemotherapy and the second stem cell rescue, patients 
receive local irradiation to the primary tumor bed.  After radiotherapy, on or 
about 84 days after the second stem cell rescue, patients receive oral 
isotretinoin twice daily for 14 consecutive days followed by 14 days rest.  
Isotretinoin treatment is repeated for 6 courses or 24 weeks.

Patients are followed every month for the first year, then every 3 months for 
the second year, then every 6 months for years 3-10, and then annually 
thereafter.

Trial Contact Information

Trial Lead Organizations

Pediatric Oncology Group

Lisa Diller, MD, Protocol chair
Ph: 617-632-5642; 866-790-4500
Email: lisa_diller@dfci.harvard.edu

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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