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Trial record 3 of 33 for:    "Ewing Sarcoma" | "Vincristine"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01313884
Recruitment Status : Terminated (Study did not reach primary objective; study did not accrue enough patients.)
First Posted : March 14, 2011
Results First Posted : February 2, 2017
Last Update Posted : November 24, 2017
Information provided by (Responsible Party):
Kristen Ganjoo, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bone Cancer Ewing's Sarcoma Drug: Irinotecan Drug: Vincristine Drug: Temozolomide Drug: Doxorubicin Drug: Cytoxan Drug: Pegfilgrastim Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Pilot Study of Cyclophosphamide, Doxorubicin, Vincristine Alternating With Irinotecan and Temozolomide in Patients With Newly Diagnosed Metastatic Ewing's Sarcoma
Study Start Date : May 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Arm Intervention/treatment
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
Drug: Irinotecan
50 mg/m2/day x 5 days
Other Names:
  • Camptosar
  • Campto

Drug: Vincristine
2 mg/m2 to a maximum of 2 mg
Other Names:
  • Oncovin
  • leurocristine

Drug: Temozolomide
100 mg/m2/day x 5 days followed by 2 weeks treatment-free
Other Names:
  • Temodar
  • Temodal

Drug: Doxorubicin
Starting dose 75 mg/m2 to a maximum of 450mg/m2
Other Names:
  • Adriamycin
  • hydroxydaunorubicin

Drug: Cytoxan
1200 mg/m2
Other Names:
  • Cyclophosphamide
  • Endoxan
  • Neosar
  • Procytox
  • Revimmune
  • cytophosphane

Drug: Pegfilgrastim
6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle
Other Name: Neulasta

Primary Outcome Measures :
  1. Overall Response Rate (Partial and Complete Response) [ Time Frame: Up to 24 months ]

    Response was evaluated every 12 weeks during treatment. Subjects who discontinue treatment for reasons other than disease progression or initiation of new anticancer therapy (excluding radiation therapy and surgery) response evaluated every 6 months following the last dose of study drug. Scans should be obtained every 6 months for up to 2 years (24 months) or until progression of disease or initiation of new anticancer therapy.

    Complete response (CR) Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.

    Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as a reference the baseline sum diameters.

Secondary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: 24 months ]
    The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01313884

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: Kristen N. Ganjoo Stanford University

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Responsible Party: Kristen Ganjoo, Assistant Professor of Medicine, Stanford University Identifier: NCT01313884     History of Changes
Other Study ID Numbers: IRB-20323
SU-03082011-7559 ( Other Identifier: Stanford University )
SARCOMA0007 ( Other Identifier: OnCore )
First Posted: March 14, 2011    Key Record Dates
Results First Posted: February 2, 2017
Last Update Posted: November 24, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sarcoma, Ewing
Bone Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors