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

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.


Condition Intervention Phase
Unspecified Childhood Solid Tumor, Protocol Specific
Drug: irofulven
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: A Trial of MGI 114 in Children With Solid Tumors: A Pediatric Oncology Group Phase I Cooperative Agreement Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 1998
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003370

  Show 56 Study Locations
Sponsors and Collaborators
Pediatric Oncology Group
Investigators
Study Chair: Gail C. Megason, MD University of Mississippi Cancer Clinic
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000066359, POG-9772
Study First Received: November 1, 1999
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00003370     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Molecular Mechanisms of Pharmacological Action
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Irofulven
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 22, 2009