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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00020111




Registration number
NCT00020111
Ethics application status
Date submitted
11/07/2001
Date registered
27/01/2003
Date last updated
29/04/2015

Titles & IDs
Public title
Arsenic Trioxide in Treating Young Patients With Refractory Leukemia or Lymphoma
Scientific title
Phase I Trial and Pharmacokinetic Study of Arsenic Trioxide in Pediatric Patients With Refractory Leukemia or Lymphoma
Secondary ID [1] 0 0
NCI-00-C-0070J
Secondary ID [2] 0 0
CDR0000067717
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Lymphoma 0 0
Condition category
Condition code
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
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed leukemia or lymphoma refractory to standard curative treatment regimens
* Measurable or evaluable disease
* No meningeal leukemia or lymphoma
* No HIV-related lymphoma
* No lymphoproliferative diseases

PATIENT CHARACTERISTICS:

Age:

* 2 to 21

* Acute promyelocytic leukemia (APL) patients (stratum I) must be age 2 to 12

Performance status:

* ECOG 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin normal
* SGPT less than 2 times upper limit of normal
* No significant hepatic dysfunction that would preclude study therapy

Renal:

* Creatinine normal (age adjusted) OR
* Creatinine clearance at least 60 mL/min
* Potassium, magnesium, and calcium at least lower limit of normal (oral or IV supplementation allowed)
* No significant renal dysfunction that would preclude study therapy

Cardiovascular:

* Rate corrected QTc interval no greater than 0.48 on EKG
* No significant cardiac dysfunction that would preclude study therapy
* No cardiac disease, including dysrhythmias

Pulmonary:

* No significant pulmonary dysfunction that would preclude study therapy

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No persistent grade 3 or greater sensory or motor neuropathy
* No prior grand mal seizures (grade 3 or greater) within the past 2 years other than febrile seizures (except for patients with APL at discretion of investigator)
* No clinically significant unrelated systemic illness that would preclude study therapy (e.g., serious infection)
* HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 1 week since prior colony-stimulating factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF], and epoetin alfa)
* No concurrent immunotherapy

Chemotherapy:

* No prior arsenic trioxide
* At least 2 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered
* No concurrent intrathecal chemotherapy except for acute promyelocytic leukemia (APL) patients experiencing progressive meningeal leukemia and demonstrating benefit from arsenic trioxide for systemic disease
* No other concurrent anticancer chemotherapy

Endocrine therapy:

* No concurrent steroids (except corticosteroids for retinoic acid syndrome)

Radiotherapy:

* At least 4 weeks since prior radiotherapy and recovered
* No concurrent radiotherapy

Surgery:

* Not specified

Other:

* At least 6 months since prior anticonvulsants
* At least 1 week since prior retinoid therapy
* No concurrent retinoids
* No other concurrent investigational agents
Minimum age
2 Years
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
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
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
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
1/03/2000
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
Georgia
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United States of America
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Illinois
Country [6] 0 0
United States of America
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Indiana
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Massachusetts
Country [10] 0 0
United States of America
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Michigan
Country [11] 0 0
United States of America
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Minnesota
Country [12] 0 0
United States of America
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Mississippi
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United States of America
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Missouri
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New Jersey
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New York
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United States of America
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North Carolina
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United States of America
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Ohio
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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Tennessee
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Texas
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Utah
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Washington
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United States of America
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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
Government body
Name
National Cancer Institute (NCI)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: This phase I trial is studying the side effects and best dose of arsenic trioxide in treating young patients with leukemia or lymphoma.
Trial website
https://clinicaltrials.gov/study/NCT00020111
Trial related presentations / publications
Fox E, Razzouk BI, Widemann BC, Xiao S, O'Brien M, Goodspeed W, Reaman GH, Blaney SM, Murgo AJ, Balis FM, Adamson PC. Phase 1 trial and pharmacokinetic study of arsenic trioxide in children and adolescents with refractory or relapsed acute leukemia, including acute promyelocytic leukemia or lymphoma. Blood. 2008 Jan 15;111(2):566-73. doi: 10.1182/blood-2007-08-107839. Epub 2007 Oct 24.
Fox E, Adamson PC, Murgo A, et al.: Phase 1 trial and pharmacokinetic study of arsenic trioxide in children with refractory leukemia. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1582, 2002.
Public notes

Contacts
Principal investigator
Name 0 0
Frank M. Balis, MD
Address 0 0
National Cancer Institute (NCI)
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/study/NCT00020111