|
Irofulven in Treating Children With Recurrent or Refractory Solid Tumors Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Irofulven in Treating Children With Recurrent or Refractory Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Irofulven in Treating Children With Recurrent or Refractory Solid Tumors Clinical research trials and Irofulven in Treating Children With Recurrent or Refractory Solid Tumors healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Irofulven in Treating Children With Recurrent or Refractory Solid Tumors. Irofulven in Treating Children With Recurrent or Refractory Solid Tumors Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Irofulven in Treating Children With Recurrent or Refractory Solid Tumors clinical trial. Test subjects typically receive the most effective healthcare possible for their Irofulven in Treating Children With Recurrent or Refractory Solid Tumors condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Irofulven in Treating Children With Recurrent or Refractory Solid Tumors  Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
For Condition: unspecified childhood solid tumor, protocol specific
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Pediatric Oncology Group
Synopsis: 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.
Details: 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. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GailMegason, Study Chair, Pediatric Oncology Group
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0296
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
Primary Children's Medical Center
Salt Lake City, Utah, 84113
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Texas Children's Cancer Center
Houston, Texas, 77030-2399
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
Veterans Affairs Medical Center - Huntington
Huntington, West Virginia, 25704
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Columbia Presbyterian Hospital
New York City, New York, 10032
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Additional Information:
Study ID Numbers: CDR0000066359; POG-9772
Study Start Date: August 1998
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003370
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory Solid Tumors
2. Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
3. Ecteinascidin 743 in Treating Children With Refractory Solid Tumors
4. Dextroamphetamine-Amphetamine Compared With Methylphenidate in Treating Children With Depression and Problems With Memory, Attention, and Thinking Caused By Cancer Treatment
5. Pemetrexed Disodium in Treating Young Patients With Recurrent Solid Tumors
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Irofulven in Treating Children With Recurrent or Refractory Solid Tumors
|
|
|
|
|
|
|
|
