Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma

Stanford University

Status and phase: Terminated; Phase 2

Conditions: Ewing's Sarcoma; Bone Cancer

Treatments: Drug: Temozolomide; Drug: Irinotecan; Drug: Doxorubicin; Drug: Pegfilgrastim; Drug: Vincristine; Drug: Cytoxan

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01313884

SU-03082011-7559 (Other Identifier)

SARCOMA0007 (Other Identifier)

IRB-20323

Details and patient eligibility

About

The outcome of patients with metastatic Ewings Sarcoma is poor with current standard of care chemotherapy, with less than 30% survival. Based on recent encouraging pediatric literature we have designed this trial to improve the outcome of patients with metastatic Ewings sarcoma using Irinotecan and Temozolomide in addition to standard chemotherapy.

Enrollment: 3 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Combination Therapy

Experimental group

Description:

Regimen A alternating with Regimen B every 21 days Regimen A: * Cytoxan 1200mg/m2 * Doxorubicin, starting dose 75 mg/m2 to a maximum of 450mg/m2 * Vincristine, starting dose 2 mg/m2 to a maximum of 2 mg * Pegfilgrastim, 6 mg subcutaneous within 24 to 48 hours after each cycle Regimen B: * Irinotecan 50 mg/m2/day x 5 days * Temozolomide 100 mg/m2/day x 5 days followed by 2 weeks treatment-free

Treatment:

Drug: Cytoxan

Drug: Vincristine

Drug: Pegfilgrastim

Drug: Doxorubicin

Drug: Irinotecan

Drug: Temozolomide