--- title: Irofulven in Treating Children With Recurrent or Refractory Solid Tumors nct_id: NCT00003370 overall_status: COMPLETED phase: PHASE1 sponsor: National Cancer Institute (NCI) study_type: INTERVENTIONAL primary_condition: Unspecified Childhood Solid Tumor, Protocol Specific countries: United States, Australia, Canada canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00003370.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00003370" ct_last_update_post_date: 2013-02-05 last_seen_at: "2026-05-12T06:19:00.784Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Irofulven in Treating Children With Recurrent or Refractory Solid Tumors **Official Title:** A Trial of MGI 114 in Children With Solid Tumors: A Pediatric Oncology Group Phase I Cooperative Agreement Study **NCT ID:** [NCT00003370](https://clinicaltrials.gov/study/NCT00003370) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE1 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 12 - **Lead Sponsor:** National Cancer Institute (NCI) - **Conditions:** Unspecified Childhood Solid Tumor, Protocol Specific - **Start Date:** 1998-08 - **CT.gov Last Update:** 2013-02-05 ## 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. ## 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. ## Eligibility - **Maximum age:** 21 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Arm I** (EXPERIMENTAL) — 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. ## Interventions - **irofulven** (DRUG) ## Locations (56) - University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States - City of Hope National Medical Center, Duarte, California, United States - University of California San Diego Cancer Center, La Jolla, California, United States - Children's Hospital Los Angeles, Los Angeles, California, United States - Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, United States - Children's Hospital of Orange County, Orange, California, United States - UCSF Cancer Center and Cancer Research Institute, San Francisco, California, United States - Stanford University Medical Center, Stanford, California, United States - Children's National Medical Center, Washington D.C., District of Columbia, United States - University of Florida Health Science Center, Gainesville, Florida, United States - Emory University Hospital - Atlanta, Atlanta, Georgia, United States - Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, United States - Children's Memorial Hospital, Chicago, Chicago, Illinois, United States - Indiana University Cancer Center, Indianapolis, Indiana, United States - University of Kansas Medical Center, Kansas City, Kansas, United States - Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States - Boston Floating Hospital Infants and Children, Boston, Massachusetts, United States - Dana-Farber Cancer Institute, Boston, Massachusetts, United States - University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States - Children's Hospital of Michigan, Detroit, Michigan, United States - University of Minnesota Cancer Center, Minneapolis, Minnesota, United States - Mayo Clinic Cancer Center, Rochester, Minnesota, United States - University of Mississippi Medical Center, Jackson, Mississippi, United States - Children's Mercy Hospital, Kansas City, Missouri, United States - Cardinal Glennon Children's Hospital, St Louis, Missouri, United States - Washington University School of Medicine, St Louis, Missouri, United States - Hackensack University Medical Center, Hackensack, New Jersey, United States - Cancer Institute of New Jersey, New Brunswick, New Jersey, United States - Roswell Park Cancer Institute, Buffalo, New York, United States - NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York, New York, United States - Memorial Sloan-Kettering Cancer Center, New York, New York, United States - Columbia Presbyterian Hospital, New York, New York, United States - State University of New York - Upstate Medical University, Syracuse, New York, United States - Duke Comprehensive Cancer Center, Durham, North Carolina, United States - Children's Hospital Medical Center - Cincinnati, Cincinnati, Ohio, United States - Children's Hospital of Columbus, Columbus, Ohio, United States - University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States - Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States - Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania, United States - Medical University of South Carolina, Charleston, South Carolina, United States - Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States - Simmons Cancer Center - Dallas, Dallas, Texas, United States - Cook Children's Medical Center - Fort Worth, Fort Worth, Texas, United States - Texas Children's Cancer Center, Houston, Texas, United States - University of Texas - MD Anderson Cancer Center, Houston, Texas, United States - University of Texas Health Science Center at San Antonio, San Antonio, Texas, United States - Primary Children's Medical Center, Salt Lake City, Utah, United States - Children's Hospital and Regional Medical Center - Seattle, Seattle, Washington, United States - Veterans Affairs Medical Center - Huntington, Huntington, West Virginia, United States - University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin, United States - Midwest Children's Cancer Center, Milwaukee, Wisconsin, United States - Royal Children's Hospital, Parkville, Victoria, Australia - Princess Margaret Hospital for Children, Perth, Western Australia, Australia - Hospital for Sick Children, Toronto, Ontario, Canada - McGill University Health Center - Montreal Children's Hospital, Montreal, Quebec, Canada - Hopital Sainte Justine, Montreal, Quebec, Canada ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - 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`locations.university of florida health science center|gainesville|florida|united states` — added _(2026-05-12)_ - `locations.emory university hospital - atlanta|atlanta|georgia|united states` — added _(2026-05-12)_ - `locations.robert h. lurie comprehensive cancer center, northwestern university|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.children's memorial hospital, chicago|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.indiana university cancer center|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.university of kansas medical center|kansas city|kansas|united states` — added _(2026-05-12)_ - `locations.sidney kimmel comprehensive cancer center at johns hopkins|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.boston floating hospital infants and children|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.dana-farber cancer institute|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.university of michigan comprehensive cancer center|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.children's hospital of michigan|detroit|michigan|united states` — added _(2026-05-12)_ - `locations.university of minnesota cancer center|minneapolis|minnesota|united states` — added _(2026-05-12)_ - `locations.mayo clinic cancer center|rochester|minnesota|united states` — added _(2026-05-12)_ - `locations.university of mississippi medical center|jackson|mississippi|united states` — added _(2026-05-12)_ - `locations.children's mercy hospital|kansas city|missouri|united states` — added _(2026-05-12)_ - `locations.cardinal glennon children's hospital|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.washington university school of medicine|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.hackensack university medical center|hackensack|new jersey|united states` — added _(2026-05-12)_ - `locations.cancer institute of new jersey|new brunswick|new jersey|united states` — added _(2026-05-12)_ - `locations.roswell park cancer institute|buffalo|new york|united states` — added _(2026-05-12)_ - `locations.nyu school of medicine's kaplan comprehensive cancer center|new york|new york|united states` — added _(2026-05-12)_ - `locations.memorial sloan-kettering cancer center|new york|new york|united states` — added _(2026-05-12)_ - `locations.columbia presbyterian hospital|new york|new york|united states` — added _(2026-05-12)_ - `locations.state university of new york - upstate medical university|syracuse|new york|united states` — added _(2026-05-12)_ - `locations.duke comprehensive cancer center|durham|north carolina|united states` — added _(2026-05-12)_ - `locations.children's hospital medical center - cincinnati|cincinnati|ohio|united states` — added _(2026-05-12)_ - `locations.children's hospital of columbus|columbus|ohio|united states` — added _(2026-05-12)_ - `locations.university of oklahoma health sciences center|oklahoma city|oklahoma|united states` — added _(2026-05-12)_ - `locations.children's hospital of philadelphia|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT00003370.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT00003370* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*