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

NCT ID: NCT01313884

Last Updated: 2017-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bone Cancer Ewing's Sarcoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Irinotecan

Intervention Type DRUG

50 mg/m2/day x 5 days

Vincristine

Intervention Type DRUG

2 mg/m2 to a maximum of 2 mg

Temozolomide

Intervention Type DRUG

100 mg/m2/day x 5 days followed by 2 weeks treatment-free

Doxorubicin

Intervention Type DRUG

Starting dose 75 mg/m2 to a maximum of 450mg/m2

Cytoxan

Intervention Type DRUG

1200 mg/m2

Pegfilgrastim

Intervention Type DRUG

6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle

Interventions

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Irinotecan

50 mg/m2/day x 5 days

Intervention Type DRUG

Vincristine

2 mg/m2 to a maximum of 2 mg

Intervention Type DRUG

Temozolomide

100 mg/m2/day x 5 days followed by 2 weeks treatment-free

Intervention Type DRUG

Doxorubicin

Starting dose 75 mg/m2 to a maximum of 450mg/m2

Intervention Type DRUG

Cytoxan

1200 mg/m2

Intervention Type DRUG

Pegfilgrastim

6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle

Intervention Type DRUG

Other Intervention Names

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Camptosar Campto Oncovin leurocristine Temodar Temodal Adriamycin hydroxydaunorubicin Cyclophosphamide Endoxan Neosar Procytox Revimmune cytophosphane Neulasta

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Kristen Ganjoo

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristen N. Ganjoo

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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SU-03082011-7559

Identifier Type: OTHER

Identifier Source: secondary_id

SARCOMA0007

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-20323

Identifier Type: -

Identifier Source: org_study_id