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

This study has been terminated.
(Study did not reach primary objective; study did not accrue enough patients.)
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Kristen Ganjoo, Stanford University
ClinicalTrials.gov Identifier:
NCT01313884
First received: March 10, 2011
Last updated: December 7, 2016
Last verified: December 2016
  Purpose
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 Intervention Phase
Bone Cancer
Ewing's Sarcoma
Drug: Irinotecan
Drug: Vincristine
Drug: Temozolomide
Drug: Doxorubicin
Drug: Cytoxan
Drug: Pegfilgrastim
Drug: Mesna
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 2 years 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:
  • Progression Free Survival [ Time Frame: 24 months ]

Enrollment: 3
Study Start Date: May 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combination Therapy

Regimen A alternate with Regimen B every 21 days

Regimen A:

Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)

Regimen B:

Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.

Drug: Irinotecan
50 mg/m2/day x 5 days
Other Names:
  • Camptosar
  • Campto
Drug: Vincristine
2 mg/m2 (capped at 2mg total do)
Other Names:
  • Oncovin
  • leurocristine
Drug: Temozolomide
100 mg/m2/day x 5 days
Other Names:
  • Temodar
  • Temodal
Drug: Doxorubicin
75 mg/m2
Other Names:
  • Adriamycin
  • hydroxydaunorubicin
Drug: Cytoxan
1200 mg/m2
Other Names:
  • Cyclophosphamide
  • Endoxan
  • Neosar
  • Procytox
  • Revimmune
  • cytophosphane
Drug: Pegfilgrastim
6 mg
Other Name: Neulasta
Drug: Mesna
240 mg/m2 in 50 ml NS
Other Names:
  • Uromitexan
  • Mesnex

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313884

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

Responsible Party: Kristen Ganjoo, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01313884     History of Changes
Other Study ID Numbers: IRB-20323
SU-03082011-7559 ( Other Identifier: Stanford University )
SARCOMA0007 ( Other Identifier: OnCore )
Study First Received: March 10, 2011
Results First Received: December 7, 2016
Last Updated: December 7, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Ewing
Bone Neoplasms
Osteosarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Cyclophosphamide
Temozolomide
Dacarbazine
Liposomal doxorubicin
Irinotecan
Doxorubicin
Camptothecin
Vincristine
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

ClinicalTrials.gov processed this record on March 30, 2017