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Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma

Primary Purpose

Sarcoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
exatecan mesylate
Sponsored by
Daiichi Sankyo, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcoma focused on measuring previously treated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • Nemours Children's Clinic
  • Cancer Institute of New Jersey
  • Memorial Sloan-Kettering Cancer Center
  • St. Jude Children's Research Hospital
  • Medical City Dallas Hospital
  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
  • University of Texas - MD Anderson Cancer Center
  • Hospital for Sick Children

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 6, 2003
Last Updated
May 15, 2012
Sponsor
Daiichi Sankyo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00055939
Brief Title
Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daiichi Sankyo, Inc.

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
previously treated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
exatecan mesylate

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. DeJager, MD, FACP
Organizational Affiliation
Daiichi Sankyo, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
St. Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-9063
Country
United States
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma

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