Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Sarcoma	Drug: exatecan mesylate	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Non-Randomized
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	January 2003
Actual Primary Completion Date :	April 2006
Actual Study Completion Date :	April 2006

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Colorado
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Denver, Colorado, United States, 80218
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
United States, New Jersey
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390-9063
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
Canada, Ontario
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8

Sponsors and Collaborators

Daiichi Sankyo, Inc.

Investigators

Study Chair:	Robert L. DeJager, MD, FACP	Daiichi Sankyo, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:	NCT00055939 History of Changes
Other Study ID Numbers:	CDR0000271888; DAIICHI-8951A-PRT033; SJCRH-DXRMS
First Posted:	March 7, 2003
Last Update Posted:	May 16, 2012
Last Verified:	May 2012

Keywords provided by Daiichi Sankyo, Inc.:

previously treated childhood rhabdomyosarcoma; recurrent childhood rhabdomyosarcoma

Additional relevant MeSH terms:

Rhabdomyosarcoma; Myosarcoma; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Exatecan	Camptothecin; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Phytogenic