NCT00055939

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2003

Typical duration for phase_2

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

May 16, 2012

Status Verified

May 1, 2012

Enrollment Period

3.2 years

First QC Date

March 6, 2003

Last Update Submit

May 15, 2012

Conditions

Sarcoma

Keywords

previously treated childhood rhabdomyosarcomarecurrent childhood rhabdomyosarcoma

Interventions

exatecan mesylateDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

University of Colorado Cancer Center at University of Colorado Health Sciences Center

Denver, Colorado, 80218, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390-9063, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Sarcoma

Interventions

exatecan

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Robert L. DeJager, MD, FACP

    Daiichi Sankyo

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2003

First Posted

March 7, 2003

Study Start

January 1, 2003

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

May 16, 2012

Record last verified: 2012-05

Locations

US(8)CA(1)