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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00003370




Registration number
NCT00003370
Ethics application status
Date submitted
1/11/1999
Date registered
9/02/2004
Date last updated
5/02/2013

Titles & IDs
Public title
Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
Scientific title
A Trial of MGI 114 in Children With Solid Tumors: A Pediatric Oncology Group Phase I Cooperative Agreement Study
Secondary ID [1] 0 0
POG-9772
Secondary ID [2] 0 0
NCI-2012-01838
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
Experimental: Arm I - If the dose limiting toxicity is myelosuppression in stratum 1, then stratum 1 is closed and stratum 2 opens.

Stratum 2 consists of the following: patients receiving no more than 2 prior chemotherapy regimens; patients who have not received prior central axis radiation or bone marrow transplantation; and patients with no known bone marrow involvement. Patients receive intravenous 6-hydroxymethylacylfulvene over 10 minutes daily for 5 days. The course is repeated every 28 days unless disease progression or unacceptable toxic effects are observed. Patients with stable or responding disease may receive up to 1 year of therapy. If dose limiting toxicity occurs in 2 of 6 patients at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Dose escalation will not occur until all patients within a cohort have been observed for 28 days from day 1 of therapy. Patients are followed until death.
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically or cytologically proven recurrent or refractory solid tumors
* No leukemia
* Patients with brain tumors are not eligible until the first 2 patients at each dose level are evaluable for toxicity

PATIENT CHARACTERISTICS:

* Age: 21 and under
* Performance status: Karnofsky 50-100% Lansky play scale 50-100% (for infants)
* Life expectancy: At least 8 weeks
* Absolute neutrophil count at least 1,000/mm3
* Hemoglobin at least 9 g/dL
* Platelet count at least 75,000/mm3
* Bilirubin less than 1.5 mg/dL
* SGPT less than 5 times upper limit of normal
* Creatinine normal for age OR GFR at least 70 mL/min
* Cardiac shortening fraction at least 27% OR institutional normal OR cardiac ejection fraction greater than 50% OR institutional normal
* Neurologic deficits in patients with CNS tumors must be stable for at least 2 weeks
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after the study
* No uncontrolled infection

PRIOR CONCURRENT THERAPY:

* At least 1 week since prior growth factor therapy and recovered
* At least 6 months since prior bone marrow transplantation and no evidence of graft versus host disease
* At least 2 weeks since prior myelosuppressive chemotherapy and recovered
* At least 6 weeks since prior nitrosourea and recovered
* At least 2 weeks on stable dexamethasone for patients with CNS tumors
* No concurrent chemotherapy
* At least 2 weeks since prior palliative radiotherapy (small port)
* At least 6 months since prior substantial bone marrow radiation
* At least 6 months since total abdominal, pelvic, chest, mantle, and Y ports radiotherapy
* No other concurrent anticancer therapy or investigational agents
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
Not applicable
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
1/08/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
12
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
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Arkansas
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California
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District of Columbia
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Florida
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Georgia
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Illinois
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Indiana
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Kansas
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Mississippi
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Washington
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West Virginia
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Wisconsin
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Canada
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Ontario
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Canada
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Quebec

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 irofulven in treating children with recurrent or refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells so they stop growing or die.
Trial website
https://clinicaltrials.gov/study/NCT00003370
Trial related presentations / publications
Bomgaars LR, Megason GC, Pullen J, Langevin AM, Dale Weitman S, Hershon L, Kuhn JG, Bernstein M, Blaney SM. Phase I trial of irofulven (MGI 114) in pediatric patients with solid tumors. Pediatr Blood Cancer. 2006 Aug;47(2):163-8. doi: 10.1002/pbc.20686.
Public notes

Contacts
Principal investigator
Name 0 0
Gail C. Megason, MD
Address 0 0
University of Mississippi Cancer Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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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/NCT00003370