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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00006463




Trial ID
NCT00006463
Ethics application status
Date submitted
6/11/2000
Date registered
23/04/2004
Date last updated
19/02/2014

Titles & IDs
Public title
Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
Scientific title
Phase I Study of ET-743 in Pediatric Refractory Solid Tumors
Secondary ID [1] 0 0
COG-P9972
Secondary ID [2] 0 0
P9972
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unspecified Childhood Solid Tumor, Protocol Specific 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ECTEINASCIDIN 743

Experimental: Therapy ECTEINASCIDIN 743 (1100 ug/m2 ) -

Experimental: ECTEINASCIDIN 743 (1300 ug/m2) -


Treatment: Drugs: ECTEINASCIDIN 743


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression Free Survival
Timepoint [1] 0 0
Length of study
Secondary outcome [1] 0 0
Dose Limiting Toxicity - To determine the maximum tolerated dose (MTD) of vincristine, when used in combination with irinotecan, and the dose-limiting toxicity (DLT) of this combination; irinotecan will be administered IV over 1 hour x 5 days, q 21 days, with vincristine IVP days 1, 8, 15, 22, 29, every 42 days, to children with refractory solid tumors.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Determine a safe and tolerable dose of vincristine, when administered with irinotecan - To determine a safe and tolerable dose of vincristine, when administered with irinotecan, for future evaluation in phase II clinical trials.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Determine the pharmacokinetics of vincristine and irinotecan - To determine the pharmacokinetics of vincristine and irinotecan (and its active metabolite SN-38) when administered in combination to children with refractory cancer.
Timepoint [3] 0 0
Length of study
Secondary outcome [4] 0 0
Determine the incidence and severity of other toxicities - To determine the incidence and severity of other toxicities of this combination.
Timepoint [4] 0 0
Length of study
Secondary outcome [5] 0 0
Seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine - To seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine against recurrent solid tumors.
Timepoint [5] 0 0
Length of study

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS: Histologically confirmed malignant solid tumor at original
diagnosis Refractory to standard treatment or no curative therapy available No CNS tumor No
bone marrow metastases (for less heavily pretreated stratum only)

PATIENT CHARACTERISTICS: Age: At least 365 days to 17 years Performance status: Karnofsky
50-100% (for patients older than 10 years) Lansky 50-100% (for patients 10 years and
younger) Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at
least 1,500/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at
least 8.0 g/dL (RBC transfusion allowed) Hepatic: Bilirubin no greater than normal SGPT no
greater than 2.5 times normal Albumin at least 2 g/dL Alkaline phosphatase normal Gamma
glutamyl transferase less than 2.5 times normal Renal: Creatinine no greater than 1.5 times
normal OR Creatinine clearance or GFR at least lower limit of normal Other: Not pregnant or
nursing Negative pregnancy test Fertile patients must use effective contraception Creatine
phosphokinase less than 2 times normal No uncontrolled infection Seizure disorder allowed
if well controlled on anticonvulsants No CNS toxicity greater than grade II

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior biologic therapy
and recovered At least 1 week since prior growth factor therapy At least 6 months since
prior peripheral blood stem cell transplantation and no evidence of graft-vs-host disease
For less heavily pretreated stratum: No prior peripheral blood stem cell transplantation
Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for
nitrosoureas) and recovered No prior ecteinascidin 743 For less heavily pretreated stratum:
No more than 2 prior chemotherapy regimens Endocrine therapy: Not specified Radiotherapy:
At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 weeks
since prior substantial bone marrow radiotherapy At least 6 months since prior craniospinal
radiotherapy or radiotherapy to 50% or greater of pelvis For less heavily pretreated
stratum: No prior craniospinal irradiation of 18Gy or greater No prior irradiation to
greater than 50% of pelvis Recovered from toxic effects of prior radiotherapy Surgery: Not
specified Other: No concurrent foods or medication that interferes with P-450 metabolism
Anticonvulsants allowed
Minimum age
1 Year
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [2] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
3052 - Parkville
Recruitment postcode(s) [2] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
New Jersey
Country [15] 0 0
United States of America
State/province [15] 0 0
New York
Country [16] 0 0
United States of America
State/province [16] 0 0
North Carolina
Country [17] 0 0
United States of America
State/province [17] 0 0
Ohio
Country [18] 0 0
United States of America
State/province [18] 0 0
Pennsylvania
Country [19] 0 0
United States of America
State/province [19] 0 0
South Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
Tennessee
Country [21] 0 0
United States of America
State/province [21] 0 0
Texas
Country [22] 0 0
United States of America
State/province [22] 0 0
Utah
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
United States of America
State/province [24] 0 0
Wisconsin
Country [25] 0 0
Canada
State/province [25] 0 0
Ontario
Country [26] 0 0
Canada
State/province [26] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.

PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children
who have refractory solid tumors.
Trial website
https://clinicaltrials.gov/show/NCT00006463
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sylvain Baruchel, MD
Address 0 0
The Hospital for Sick Children
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries