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A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma


Phase 2
13 Years
N/A
Open (Enrolling)
Both
Bone Cancer, Ewing's Sarcoma

Thank you

Trial Information

A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of metastatic Ewing's sarcoma.

- Patients must have measurable disease defined as lesions that can be measured by
medical imaging techniques such as CT or MRI. Ascites, pleural fluid, bone marrow
disease, lesions seen on scan will not be considered measurable.

- Patients must have metastatic disease.

- Age 13 years or older

- Life expectancy of at least 3 months.

- ECOG performance status of <= 3.

- Normal hepatic function (Direct bilirubin <1.5mg/dl, SGOT or SGPT <3x upper limit of
normal).

- Left Ventricular Ejection fraction of at least 50%.

- Adequate renal function: Creatinine clearance >= 50 ml/min or Serum creatinine < 1.5
x ULN for age.

- Adequate bone marrow reserve (defined as an absolute peripheral granulocyte count of
>=1500/mm3, platelet count of >=75,000/mm3); unless bone marrow infiltrated with
metastatic Ewing's sarcoma; ANC >= 500 and Platelet >= 50,000 mm3.

- Ability to understand and willing to sign a written informed consent document.

- Patients of childbearing potential must agree to use an effective method of
contraception.

Exclusion Criteria:

- No prior chemotherapy for Ewing's sarcoma; No prior doxorubicin, temozolomide or
irinotecan.

- Known hypersensitivity to any of the components of the protocol drugs.

- Clinically significant unrelated systemic illness (such as serious infections
requiring active systemic intravenous antibiotic therapy; cardiovascular disease
[congestive heart failure, recent myocardial infarction, unstable angina,
inadequately controlled hypertension].

- No prior history of chronic diarrhea, bowel obstruction, Crohn's disease or
ulcerative colitis.

- Pregnant or nursing woman are not included in the study.

- HIV-positive patients will be excluded from the study due to risk of infection or
other serious side effects.

- Other medical, psychiatric or social condition incompatible with study treatment.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response Rate (Partial and Complete Response)

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Kristen N. Ganjoo

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

SARCOMA0007

NCT ID:

NCT01313884

Start Date:

May 2011

Completion Date:

June 2016

Related Keywords:

  • Bone Cancer
  • Ewing's Sarcoma
  • Bone Neoplasms
  • Osteosarcoma
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Stanford University School of MedicineStanford, California  94305-5317