Irofulven in Treating Children With Recurrent or Refractory Solid Tumors

NCT00003370 | Completed Phase 1

• 3 other identifiers: NCI-2012-01838POG-9772CDR0000066359
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 56

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.

Conditions

Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

unspecified childhood solid tumor, protocol specific

Study Arms (1)

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.

Drug: irofulven

Interventions

irofulven DRUG

Arm I

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (56)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

City of Hope National Medical Center

Duarte, California, 91010, United States

Location

University of California San Diego Cancer Center

La Jolla, California, 92093-0658, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

UCSF Cancer Center and Cancer Research Institute

San Francisco, California, 94143-0128, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5408, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

University of Florida Health Science Center

Gainesville, Florida, 32610-0296, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Children's Memorial Hospital, Chicago

Chicago, Illinois, 60614, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160-7357, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Boston Floating Hospital Infants and Children

Boston, Massachusetts, 02111, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0752, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216-4505, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cardinal Glennon Children's Hospital

St Louis, Missouri, 63104, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Columbia Presbyterian Hospital

New York, New York, 10032, United States

Location

State University of New York - Upstate Medical University

Syracuse, New York, 13210, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital Medical Center - Cincinnati

Cincinnati, Ohio, 45229-3039, United States

Location

Children's Hospital of Columbus

Columbus, Ohio, 43205-2696, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73190, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-0721, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Texas Children's Cancer Center

Houston, Texas, 77030-2399, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78284-7811, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Veterans Affairs Medical Center - Huntington

Huntington, West Virginia, 25704, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Midwest Children's Cancer Center

Milwaukee, Wisconsin, 53226, United States

Location

Royal Children's Hospital

Parkville, Victoria, 3052, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6001, Australia

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

McGill University Health Center - Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

• 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.

  PMID: 16317728 RESULT

MeSH Terms

Interventions

irofulven

Study Officials

• Gail C. Megason, MD

  University of Mississippi Cancer Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: February 9, 2004
• Study Start: August 1, 1998
• Primary Completion: March 1, 2006
• Last Updated: February 5, 2013

Record last verified: 2006-05

Locations

AU (2); CA (3); US (51)