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

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT01313884
Phase
PHASE2
Status
Terminated

Conditions

  • Bone Cancer
  • Ewing's Sarcoma

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan — DRUG
    50 mg/m2/day x 5 days
  • Vincristine — DRUG
    2 mg/m2 to a maximum of 2 mg
  • Temozolomide — DRUG
    100 mg/m2/day x 5 days followed by 2 weeks treatment-free
  • Doxorubicin — DRUG
    Starting dose 75 mg/m2 to a maximum of 450mg/m2
  • Cytoxan — DRUG
    1200 mg/m2
  • Pegfilgrastim — DRUG
    6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle

Study Details

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.

Key Dates

Start date
May 31, 2011
Status verified
Dec 2016
Primary completion
Jul 31, 2014
Completion
Jul 31, 2014

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy
    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

Primary Outcome Measure

Overall Response Rate (Partial and Complete Response) [ Time Frame: Up to 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-

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By research site
Stanford University School of Medicine· Stanford, CA

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