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Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors Clinical research trials and Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors. Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors clinical trial. Human subjects often obtain the finest healthcare possible for their Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors  Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
For Condition: Brain Tumors,Musculoskeletal Tumors,Solid Tumors,Kidney Tumors
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Children's Cancer Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as thrombopoietin and G-CSF may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of colony-stimulating factors in treating children who have recurrent or refractory solid tumors and who are receiving chemotherapy.
Details: OBJECTIVES: I. Determine the pharmacokinetics and toxicities associated with the administration of recombinant human thrombopoietin in children with solid tumors receiving myelosuppressive chemotherapy with ifosfamide, carboplatin, and etoposide (ICE). II. Determine a safe dose of recombinant human thrombopoietin with filgrastim (G-CSF) in this patient population. III. Evaluate the time to platelet count recovery following chemotherapy in this patient population. IV. Evaluate the depth and duration of neutropenia and thrombocytopenia and the number of platelet transfusion events in this patient population. PROTOCOL OUTLINE: This is a dose escalation study of recombinant human thrombopoietin. All patients receive chemotherapy consisting of carboplatin IV over 60 minutes on days 0 and 1 and etoposide and ifosfamide IV over 60 minutes on days 0-4. Chemotherapy is continued in the absence of disease progression or unacceptable toxicity for a maximum of 6 courses every 21 days. Cohorts of 3-6 patients each receive escalating doses of recombinant human thrombopoietin IV on days 4, 6, 8, 10, and 12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which fewer than 2 patients experience dose limiting toxicity. After the MTD is determined an additional cohort of patients are treated at this dose level every other day on days 4-20. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 5 and continuing until absolute neutrophil count is greater than 1000/mm3 for 2 consecutive days or day 33. PROJECTED ACCRUAL: A total of 24 evaluable patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: 1 Year/21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven (except for brain stem tumors) malignancy that has failed or relapsed after standard first-line antineoplastic therapy Sarcoma (soft tissue and bone) Kidney tumors Brain tumors Other solid tumors (gonadal and germ cell tumors, malignant melanoma, retinoblastoma, liver tumors, and miscellaneous tumors) Must have had recurrence within the past 4 weeks No bone marrow involvement No prior or concurrent myelogenous leukemia --Prior/Concurrent Therapy-- Biologic therapy: At least 10 days since prior colony-stimulating factor therapy and recovered At least 30 days since prior epoetin alfa No other concurrent cytokines, including epoetin alfa Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered At least 3 months since therapy with etoposide, carboplatin, or ifosfamide that is identical to study treatment Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed after third course of therapy No prior cranial/spinal radiotherapy No prior radiotherapy to greater than 50% of bone marrow Surgery: Concurrent surgery allowed after the second course of therapy Other: No concurrent investigational agents No concurrent lithium, aspirin, coumadin, or heparin --Patient Characteristics-- Age: 1 to 21 Performance status: Lansky or Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1000/mm3 Platelet count greater than 100,000/mm3 No grade III or IV thrombosis Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT or SGPT less than 2.5 times ULN Renal: Creatinine clearance or glomerular filtration rate at least 70 mL/min Cardiovascular: Ejection fraction normal No evidence of arrhythmias requiring therapy Fractional shortening greater than 28% Other: Not pregnant or nursing
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MitchellCairo, Study Chair, Children's Cancer Group
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, 64108
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
Beckman Research Institute, City of Hope
Los Angeles, California, 91010
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5265
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Vanderbilt Cancer Center
Nashville, Tennessee, 37232-6838
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84132
United States
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
Children's Hospital of Orange County
Orange, California, 92668
United States
Kaplan Cancer Center
New York City, New York, 10016
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94115-0128
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
Additional Information:
Study ID Numbers: CDR0000066668; CCG-09717
Study Start Date: November 1998
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003597
Other Musculoskeletal Tumors Studies:
1. Phase I study of PN401, fluorouracil, leucovorin and CPT-11 in patients with solid tumors
2. Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
3. A Phase 1 Study of S-3304 in Patients with Solid Tumors
Related Studies:
Other Musculoskeletal Tumors Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Colony-Stimulating Factors in Treating Children With Recurrent or Refractory Solid Tumors
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