- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00055939
Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
A Phase II Study Of Intravenous DX-8951f (EXATECAN MESYLATE) Administered Daily For Five Days Every Three Weeks To Pediatric Patients With Relapsed Or Refractory Rhabdomyosarcoma
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 children who have relapsed or refractory rhabdomyosarcoma.
Study Overview
Detailed Description
OBJECTIVES:
- Determine the objective response rate (complete and partial responses) in pediatric patients with relapsed or refractory rhabdomyosarcoma treated with exatecan mesylate.
- Determine the time to tumor progression in patients treated with this drug.
- Determine the median survival and survival at 6 and 12 months in patients treated with this drug.
- Assess pain in patients treated with this drug.
- Evaluate the quantitative and qualitative toxic effects of this drug in these patients.
- Evaluate the pharmacokinetics of this drug in these patients.
OUTLINE: This is an open-label, nonrandomized, multicenter study.
Patients receive exatecan mesylate IV over 30 minutes on days 1-5. Treatment repeats every 3 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 6 additional courses beyond CR.
PROJECTED ACCRUAL: A total of 13-27 patients will be accrued for this study within 1 year.
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:
- Histologically confirmed recurrent or resistant rhabdomyosarcoma
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 old)
- Lansky 60-100% (10 years old 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
- Albumin at least 2.8 g/dL
- AST or ALT no greater than 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
Renal
- Creatinine no greater than 1.5 times ULN
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No life threatening illness (unrelated to tumor) within the past 6 months
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No concurrent active serious infection
- No concurrent uncontrolled infection
- No overt psychosis or other incompetency that would preclude study compliance or giving informed consent
- No other concurrent noncancer-related illness that would preclude study participation or follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 3 months since prior autologous bone marrow or stem cell transplantation
- No concurrent anticancer biologic therapy
Chemotherapy
- Recovered from prior adjuvant or systemic chemotherapy
- Prior topoisomerase I inhibitor therapy allowed
- No other concurrent anticancer chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- More than 4 weeks since prior extensive radiotherapy to the cranial-spinal axis, whole pelvis, or 25% of marrow reserve
- No concurrent anticancer radiotherapy
Surgery
- At least 4 weeks since prior major surgery
- Recovered from prior surgery
- No concurrent anticancer surgery
Other
- At least 28 days since prior investigational drugs (including analgesics or antiemetics)
- No more than 2 prior regimens for rhabdomyosarcoma
- No concurrent grapefruit-containing beverages or foods
- No other concurrent investigational drugs during and for 28 days after final dose of study drug
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- 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
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000271888
- DAIICHI-8951A-PRT033
- SJCRH-DXRMS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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