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Phase II Study of Cyclophosphamide, Doxorubicin, Vincristine, Etoposide, and Ifosfamide, Followed by Resection and Radiotherapy in Patients With Peripheral Primitive Neuroectodermal Tumors or Ewing's Sarcoma


Phase 2
N/A
N/A
Not Enrolling
Both
Kidney Cancer, Sarcoma

Thank you

Trial Information

Phase II Study of Cyclophosphamide, Doxorubicin, Vincristine, Etoposide, and Ifosfamide, Followed by Resection and Radiotherapy in Patients With Peripheral Primitive Neuroectodermal Tumors or Ewing's Sarcoma


OBJECTIVES: I. Determine the response rate and event-free survival of patients with
peripheral primitive neuroectodermal tumors or Ewing's sarcoma treated with
cyclophosphamide, doxorubicin, vincristine, etoposide, and ifosfamide, followed by surgery
(if feasible) and radiotherapy. II. Determine the response to a uniform treatment regimen in
order to clarify whether these disease categories each have a different prognosis.

OUTLINE: Patients are stratified according to disease category (primitive neuroectodermal
tumor vs Ewing's sarcoma). Patients receive treatment on regimen A as outlined below during
courses 1-3 and 6 and regimen B as outlined below during courses 4, 5, and 7 in the absence
of disease progression or unacceptable toxicity. Each course lasts 3-4 weeks. Patients
without metastatic disease after completion of course 3 undergo complete tumor resection, if
feasible. Patients achieving complete response with or without microscopic residual disease
after completion of course 7 undergo radiotherapy twice daily, 5 days a week, for 3 weeks.
Patients with gross residual disease after completion of course 7 undergo radiotherapy twice
daily, 5 days a week, for 3.6 weeks. Regimens A and B are defined below: Regimen A: Patients
receive cyclophosphamide IV over 6 hours on days 1 and 2, doxorubicin IV continuously and
vincristine IV continuously on days 1-3, and vincristine IV on day 9. Regimen B: Patients
receive etoposide IV over 1 hour, followed immediately by ifosfamide IV over 1 hour on days
1-5. Patients are followed monthly for 18 months and then every 6 months for 18 months.

PROJECTED ACCRUAL: A maximum of 50 patients (25 per stratum) will be accrued for this study
within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of peripheral primitive neuroectodermal tumor,
including peripheral neuroepithelioma or Askin tumor OR Diagnosis of localized or
metastatic Ewing's sarcoma, including the following: Unresectable or metastatic small cell
osteosarcoma Unresectable or metastatic other nonrhabdomyosarcomatous soft-tissue sarcomas
Unresectable or metastatic other non-osteosarcomatous bone sarcomas Desmoplastic small
round-cell tumor Metastatic or non-metastatic Wilms' tumor Immunocytochemistry, electron
microscopy, and/or chromosomal analysis may be required to rule out other small round cell
neoplasms

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy:
Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified

PRIOR CONCURRENT THERAPY: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Brian H. Kushner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

90-062

NCT ID:

NCT00002466

Start Date:

May 1990

Completion Date:

May 2005

Related Keywords:

  • Kidney Cancer
  • Sarcoma
  • localized osteosarcoma
  • metastatic osteosarcoma
  • stage III adult soft tissue sarcoma
  • stage III Wilms tumor
  • stage IV Wilms tumor
  • nonmetastatic childhood soft tissue sarcoma
  • metastatic childhood soft tissue sarcoma
  • childhood desmoplastic small round cell tumor
  • localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • stage IV adult soft tissue sarcoma
  • Askin tumor
  • peripheral primitive neuroectodermal tumor
  • Carcinoma, Renal Cell
  • Kidney Neoplasms
  • Wilms Tumor
  • Neuroectodermal Tumors
  • Neuroectodermal Tumors, Primitive
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021