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Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
This study has been completed.
Study NCT00003370   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes

November 1, 1999
July 23, 2008
August 1998
 
 
 
Complete list of historical versions of study NCT00003370 on ClinicalTrials.gov Archive Site
 
 
 
Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
A Trial of MGI 114 in Children With Solid Tumors: A Pediatric Oncology Group Phase I Cooperative Agreement Study

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of irofulven in treating children with recurrent or refractory solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of 6-hydroxymethylacylfulvene (MGI-114) in pediatric patients with recurrent or refractory solid tumors. II. Determine the incidence and severity of other toxic effects of MGI-114. III. Determine a safe and tolerable dose of MGI-114 to be used in phase II studies. IV. Determine the pharmacokinetics of MGI-114 in these patients. V. Determine preliminary evidence of antitumor activity of MGI-114 against recurrent or refractory pediatric solid tumors.

OUTLINE: This is a dose escalation study. 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.

PROJECTED ACCRUAL: Approximately 12 patients will be accrued per year.

Phase I
Interventional
Treatment
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: irofulven
 
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.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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 Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Hemoglobin at least 9 g/dL Platelet count at least 75,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL SGPT less than 5 times upper limit of normal Renal: Creatinine normal for age OR GFR at least 70 mL/min Cardiovascular: Cardiac shortening fraction at least 27% OR institutional normal OR Cardiac ejection fraction greater than 50% OR institutional normal Neurologic: Neurologic deficits in patients with CNS tumors must be stable for at least 2 weeks Other: 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: Biologic 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 Chemotherapy: 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 Endocrine therapy Not specified Radiotherapy: 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 Surgery: Not specified Other: No other concurrent anticancer therapy or investigational agents

Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada
 
NCT00003370
 
CDR0000066359, POG-9772
Pediatric Oncology Group
National Cancer Institute (NCI)
Study Chair: Gail C. Megason, MD University of Mississippi Cancer Clinic
National Cancer Institute (NCI)
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP