Exatecan Mesylate in Treating Children With Relapsed or Refractory Rhabdomyosarcoma

Sponsor

Daiichi Sankyo, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00055939

Collaborator

(none)

Locations

Duration (Months)

Study Details

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.

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

Study Type:

Interventional

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 :

Jan 1, 2003

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Apr 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Denver	Colorado	United States	80218
2	Nemours Children's Clinic	Jacksonville	Florida	United States	32207
3	Cancer Institute of New Jersey	New Brunswick	New Jersey	United States	08903
4	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10021
5	St. Jude Children's Research Hospital	Memphis	Tennessee	United States	38105
6	Medical City Dallas Hospital	Dallas	Texas	United States	75230
7	Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas	United States	75390-9063
8	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030-4009
9	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Daiichi Sankyo, Inc.

ClinicalTrials.gov Identifier:

NCT00055939

Other Study ID Numbers:

CDR0000271888
DAIICHI-8951A-PRT033
SJCRH-DXRMS

First Posted:

Mar 7, 2003

Last Update Posted:

May 16, 2012

Last Verified:

May 1, 2012

Keywords provided by Daiichi Sankyo, Inc.

previously treated childhood rhabdomyosarcoma

recurrent childhood rhabdomyosarcoma

Additional relevant MeSH terms:

Rhabdomyosarcoma

Exatecan

Study Results

No Results Posted as of May 16, 2012