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

Primary Purpose

Bone Cancer, Ewing's Sarcoma

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Irinotecan
Vincristine
Temozolomide
Doxorubicin
Cytoxan
Pegfilgrastim
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Cancer

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combination Therapy

Arm 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

Outcomes

Primary Outcome Measures

Overall Response Rate (Partial and Complete Response)
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

Progression-free Survival (PFS)
The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.

Full Information

First Posted
March 10, 2011
Last Updated
October 20, 2017
Sponsor
Stanford University
Collaborators
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT01313884
Brief Title
Cyclophosphamide, Doxorubicin, Vincristine w/ Irinotecan and Temozolomide in Ewings Sarcoma
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 Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Terminated
Why Stopped
Study did not reach primary objective; study did not accrue enough patients.
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Amgen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Cancer, Ewing's Sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination Therapy
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Other Intervention Name(s)
Camptosar, Campto
Intervention Description
50 mg/m2/day x 5 days
Intervention Type
Drug
Intervention Name(s)
Vincristine
Other Intervention Name(s)
Oncovin, leurocristine
Intervention Description
2 mg/m2 to a maximum of 2 mg
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Other Intervention Name(s)
Temodar, Temodal
Intervention Description
100 mg/m2/day x 5 days followed by 2 weeks treatment-free
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriamycin, hydroxydaunorubicin
Intervention Description
Starting dose 75 mg/m2 to a maximum of 450mg/m2
Intervention Type
Drug
Intervention Name(s)
Cytoxan
Other Intervention Name(s)
Cyclophosphamide, Endoxan, Neosar, Procytox, Revimmune, cytophosphane
Intervention Description
1200 mg/m2
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Other Intervention Name(s)
Neulasta
Intervention Description
6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle
Primary Outcome Measure Information:
Title
Overall Response Rate (Partial and Complete Response)
Description
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.
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
The intended outcome is a measure of whether participants are alive without disease progression 2 years (24 months) after treatment.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen N. Ganjoo
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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