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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00005577




Registration number
NCT00005577
Ethics application status
Date submitted
2/05/2000
Date registered
2/04/2004
Date last updated
5/02/2013

Titles & IDs
Public title
Gemcitabine in Treating Children With Refractory Solid Tumors
Scientific title
A PEDIATRIC PHASE I STUDY OF GEMCITABINE (NSC# 613327) IN SOLID TUMORS
Secondary ID [1] 0 0
CCG-0954
Secondary ID [2] 0 0
NCI-2012-02246
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 - gemcitabine hydrochloride

Experimental: Arm I - Patients receive gemcitabine IV over 30 minutes weekly for 2 weeks. Patients achieving objective response or stable disease after 3 weeks may receive additional courses of therapy every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicity.


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

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Histologically confirmed malignant solid tumor Confirmation made at original diagnosis

- No bone marrow involvement

- Refractory to conventional therapy and other therapies of higher priority according to
CCG Phase I/II Priority List

PATIENT CHARACTERISTICS:

- Age: 1 to 21

- Performance status: 0-2

- Life expectancy: At least 2 months

- Absolute neutrophil count at least 1,000/mm3

- Platelet count at least 100,000/mm3 (transfusion independent)

- Hemoglobin at least 10 g/dL (transfusions allowed)

- Bilirubin no greater than 1.5 times normal

- AST less than 2.5 times normal

- Creatinine no greater than 1.5 times normal OR creatinine clearance or radioisotope
GFR at least 70 mL/min

- No seizure disorder Not pregnant or nursing

- Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

- At least 2 weeks since prior cytokine therapy and recovered

- No prior bone marrow transplantation

- No more than 3 prior combination or single agent chemotherapy regimens

- At least 3 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered
Minimum age
1 Year
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
1/08/1996
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6001 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Washington
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin

Funding & Sponsors
Primary sponsor type
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Phase I trial to study the effectiveness of gemcitabine in treating children who have
refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells
from dividing so they stop growing or die.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00005577
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John S. Holcenberg, MD
Address 0 0
Seattle Children's Hospital
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00005577