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Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy Clinical research trials and Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy. Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy clinical trial. Subjects often receive the most expert healthcare possible for their Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy  Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
For Condition: unspecified childhood solid tumor, protocol specific,Drug Toxicity
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 from dividing so they stop growing or die. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of irinotecan and cisplatin with or without amifostine in treating children who have solid tumors that have not responded to previous therapy.
Details: OBJECTIVES: I. Determine the maximum tolerated dose (MTD) of irinotecan when administered with cisplatin, with or without amifostine, to children with refractory solid tumors. II. Determine the dose limiting toxicities of the combination of irinotecan and cisplatin, with and without amifostine, in this patient population. III. Determine the pharmacokinetics of cisplatin with and without amifostine in these patients. IV. Quantify the leukocyte DNA-platinum adduct formation, with and without amifostine, and correlate it with response and toxicity in these patients. V. Determine the safety and efficacy of the doses and schedules of administration to be used in phase II clinical trials. PROTOCOL OUTLINE: This is a dose escalation study of irinotecan. Treatment A: Patients receive cisplatin IV over 1 hour followed immediately by irinotecan IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 6 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Treatment B: Patients receive therapy as in treatment A. In addition, amifostine IV is administered over 15 minutes immediately before cisplatin. Cohorts of 3-6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Once the MTD of treatment A is determined, additional patients are accrued to determine the MTD of treatment B. If myelosuppression is the dose limiting toxicity of treatment A, then stratum 1 closes and stratum 2 opens and these patients with less prior therapy receive treatment A. Treatment B is then only open to stratum 3 patients. Patients are followed every 6 months for 4 years, then annually thereafter. PROJECTED ACCRUAL: A total of 3-30 patients will be accrued for this study within 2.5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed solid tumor that is refractory to standard therapy or for which no effective therapy exists; Brainstem gliomas allowed without histologic diagnosis; Brain tumors allowed provided not receiving anticonvulsants - Strata 2 and 3: No bone marrow involvement --Prior/Concurrent Therapy-- - Biologic therapy: At least 1 week since prior biologic therapy and recovered; At least 6 months since prior autologous or allogeneic bone marrow transplantation without total body irradiation (TBI); At least 1 week since prior growth factors; Strata 2 and 3: No prior stem cell transplantation (with or without TBI) - Chemotherapy: At least 3 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered; At least 1 week since prior antineoplastic agents; No other concurrent chemotherapy; Strata 2 and 3: No more than 2 prior chemotherapy regimens (single or multiagent) - Endocrine therapy: If receiving dexamethasone for CNS tumors, must be on stable or decreasing dose for at least 2 weeks - Radiotherapy: At least 2 weeks since prior local radiation (small port); At least 6 months since prior craniospinal radiation; At least 6 months since prior radiation to at least 50% of pelvis; At least 6 weeks since prior substantial bone marrow radiation; Recovered from prior radiotherapy; Strata 2 and 3: No prior central axis radiotherapy - Surgery: Not specified - Other: No other concurrent investigational agents; No other concurrent anticancer therapy; No concurrent anticonvulsants --Patient Characteristics-- - Age: 1 to 21 - Performance status: Karnofsky 50-100% for patients over 10 years of age OR Lansky 50-100% for patients 10 years of age and under - Life expectancy: At least 8 weeks - Hematopoietic: Absolute neutrophil count at least 1,000/mm3; Hemoglobin at least 8.0 g/dL; Platelet count at least 100,000/mm3 - Hepatic: Albumin at least 2.5 g/dL; Bilirubin no greater than 1.5 mg/dL; SGPT no greater than 2 times upper limit of normal - Renal: Creatinine normal for age OR GFR normal for age - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; If CNS tumor, neurologic deficits relatively stable for at least 2 weeks; Must be at least third percentile weight for height; No concurrent significant systemic illness (e.g., infection, fever, mucositis, severe anorexia, and severe malnutrition); No uncontrolled infections; No evidence of graft versus host disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AbdulSouid, Study Chair, Pediatric Oncology Group
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Royal Children's Hospital
Parkville, Victoria, 3052
Australia
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Primary Children's Medical Center
Salt Lake City, Utah, 84113
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Stanford University Medical Center
Stanford, California, 94305-5408
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Columbia Presbyterian Hospital
New York City, New York, 10032
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Texas Children's Cancer Center
Houston, Texas, 77030-2399
United States
University of Florida Health Science Center
Gainesville, Florida, 32610-0296
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Cook Children's Medical Center - Fort Worth
Ft. Worth, Texas, 76104
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Children's Hospital of Orange County
Orange, California, 92868
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Additional Information:
Study ID Numbers: CDR0000067601; POG-9970,CCG-P9970
Study Start Date: December 1999
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004919
Other Drug Toxicity Studies:
1. Amifostine and Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
2. Triacetyluridine and Fluorouracil Compared With Gemcitabine in Treating Patients With Unresectable Locally Advanced, or Metastatic Pancreatic Cancer
3. Rituximab, Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Sodium Thiosulfate and Cytarabine in Treating Patients With Refractory or Recurrent Primary CNS Lymphoma
4. Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx
5. Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
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Irinotecan and Cisplatin With or Without Amifostine in Treating Children With Solid Tumors That Have Not Responded to Previous Therapy
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