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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/NCT00006462




Registration number
NCT00006462
Ethics application status
Date submitted
6/11/2000
Date registered
27/01/2003
Date last updated
20/02/2014

Titles & IDs
Public title
Gemcitabine in Treating Children With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
Scientific title
A Phase II Study of Gemcitabine (NSC #613327) in Children With Relapsed Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia
Secondary ID [1] 0 0
COG-ADVL0022
Secondary ID [2] 0 0
ADVL0022
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

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

Experimental: Relapsed acute lymphoblastic and acute Myelogenous leukemia - Gemcitabine hydrochloride will be given as 10 mg/m2/min x 360 minutes weekly for three weeks. After a one-week rest period it may be repeated in patients without progressive disease or limiting toxicity.


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

Outcomes
Primary outcome [1] 0 0
Determine the response rate to Gemcitabine
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

- Diagnosis of relapsed acute lymphoblastic leukemia or acute myelogenous leukemia

- M3 marrow (at least 25% blasts in bone marrow aspirate)

- Refractory to conventional therapy

PATIENT CHARACTERISTICS:

Age:

- 21 and under at diagnosis

Performance status:

- ECOG 0-2 OR

- Zubrod 0-2

Life expectancy:

- At least 2 months

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin normal

- SGOT or SGPT no greater than 2.5 times upper limit of normal

Renal:

- Creatinine normal OR

- Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent immunomodulating agents

Chemotherapy:

- At least 2 weeks since prior chemotherapy

- No other concurrent chemotherapy for cancer

Endocrine therapy:

- No concurrent corticosteroids except for treatment of adrenal crises with suppressed
pituitary/adrenal response

- Concurrent low-dose hydrocortisone (less than 100 mg/m2) allowed for allergic
reactions to amphotericin or transfusions

Radiotherapy:

- Concurrent radiotherapy to localized painful lesions allowed

Surgery:

- Not specified

Other:

- Recovered from any prior therapy
Minimum age
No limit
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 2
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
1/04/2001
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Children's Hospital at Westmead - Westmead
Recruitment hospital [3] 0 0
Royal Children's Hospital - Brisbane
Recruitment hospital [4] 0 0
Women's and Children's Hospital - North Adelaide
Recruitment hospital [5] 0 0
Royal Children's Hospital - Parkville
Recruitment hospital [6] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
3052 - Parkville
Recruitment postcode(s) [6] 0 0
6001 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Colorado
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Connecticut
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Delaware
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Maine
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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.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating children who
have relapsed or refractory acute lymphoblastic leukemia or acute myelogenous leukemia.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00006462
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne Angiolillo, MD
Address 0 0
Children's National Research Institute
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/NCT00006462