- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00055952
Exatecan Mesylate in Treating Patients With Ewing's Sarcoma, Primitive Neuroectodermal Tumor, or Desmoplastic Small Round Cell Tumor
A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric And Young Adult Patients With Ewing's Sarcoma (ES), Primitive Neuroectodermal Tumor (PNET), Or Desmoplastic Small Round Cell Tumor (DSRCT)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of exatecan mesylate in treating patients who have relapsed or refractory Ewing's sarcoma or peripheral primitive neuroectodermal tumor or desmoplastic small round cell tumor.
Study Overview
Detailed Description
OBJECTIVES:
- Determine the objective response rate in patients with Ewing's sarcoma, primitive neuroectodermal tumor, or desmoplastic small round cell tumor treated with exatecan mesylate.
- Determine the time to tumor progression in patients treated with this drug.
- Determine median survival and 6- and 12-month survival of patients treated with this drug.
- Determine the pain response in patients treated with this drug.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, non-randomized, multicenter study. Patients are stratified according to disease (relapsed or refractory localized or metastatic Ewing's sarcoma or primitive neuroectodermal tumor vs desmoplastic small round cell tumor).
Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity for a maximum of 12 courses, or 6 courses beyond maximal response (whichever is longer).
Patients are followed every 3 months for 1 year after withdrawal from study.
PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for stratum I within 12 months. A total of 9-17 patients will be accrued for stratum II within 15 months.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Colorado
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Denver, Colorado, United States, 80218
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
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Florida
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Jacksonville, Florida, United States, 32207
- Nemours Children's Clinic
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New Jersey
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New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey
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New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Texas
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Dallas, Texas, United States, 75230
- Medical City Dallas Hospital
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Dallas, Texas, United States, 75390-9063
- Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
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Houston, Texas, United States, 77030-4009
- University of Texas - MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
One of the following histologically confirmed diagnoses:
- Relapsed or refractory Ewing's sarcoma or primitive neuroectodermal tumor
- Desmoplastic small round cell tumor
Measurable disease
The following are not considered measurable disease:
- Ascites
- Pleural effusion
- Lytic bone lesions
- No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- ECOG 0-2 (over 10 years of age)
- Lansky 60-100% (10 years of age and under)
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count at least 750/mm^3
- Platelet count at least 75,000/mm^3
- Hemoglobin at least 8.5 g/dL
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
- Albumin at least 2.8 g/dL
Renal
- Creatinine less than 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active serious infection
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No overt psychosis or mental disability that would preclude informed consent
- No other life-threatening illness within the past 6 months
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 months since prior autologous bone marrow or stem cell transplantation
- No concurrent biologic therapy
Chemotherapy
- Recovered from prior systemic chemotherapy
- Prior topoisomerase I inhibitor therapy allowed
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- More than 4 weeks since prior cranial, spinal, or whole pelvis radiotherapy
- More than 4 weeks since prior radiotherapy to 25% of bone marrow reserve
- No concurrent radiotherapy
Surgery
- At least 4 weeks since prior major surgery and recovered
- No concurrent surgery
Other
- More than 28 days since prior investigational drugs (including analgesics or antiemetics)
- No more than 2 prior treatment regimens for this disease
- No other investigational drugs during and for 28 days after study therapy
- No other concurrent anticancer therapy
- No concurrent grapefruit or grapefruit juice
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
- recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
- metastatic childhood soft tissue sarcoma
- recurrent childhood soft tissue sarcoma
- nonmetastatic childhood soft tissue sarcoma
- childhood desmoplastic small round cell tumor
- localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Osteosarcoma
- Neoplasms, Bone Tissue
- Neoplasms, Connective Tissue
- Sarcoma
- Sarcoma, Ewing
- Neuroectodermal Tumors
- Neuroectodermal Tumors, Primitive
- Desmoplastic Small Round Cell Tumor
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Exatecan
Other Study ID Numbers
- CDR0000271889
- DAIICHI-8951A-PRT034
- SJCRH-DXEWS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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