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Home > "D" Clinical Trials Conditions > Docetaxel in Treating Children With Recurrent Solid Tumors  Docetaxel in Treating Children With Recurrent Solid Tumors
Docetaxel in Treating Children With Recurrent Solid Tumors
For Condition: recurrent childhood rhabdomyosarcoma,recurrent neuroblastoma,recurrent childhood ependymoma,recurrent childhood soft tissue sarcoma,recurrent tumors of the Ewing's family,recurrent childhood brain stem glioma,recurrent childhood cerebellar astrocytoma,recurrent childhood medulloblastoma,recurrent childhood cerebral astrocytoma,recurrent childhood supratentorial primitive neuroectodermal and pineal tumors,recurrent osteosarcoma
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. PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating children with recurrent solid tumors.
Details: OBJECTIVES: I. Determine the response rate to docetaxel in children with recurrent sarcomas, neuroblastomas, or brain tumors. II. Describe the toxic effects of docetaxel in these patients. PROTOCOL OUTLINE: All patients receive docetaxel with G-CSF every 21 days for up to 12 courses. Patients are followed for survival. PROJECTED ACCRUAL: A total of 20 patients per disease category (soft tissue sarcomas, osteosarcoma, neuroblastoma, medulloblastoma/PNET, and astrocytoma/glioma) will be accrued for this study over 2-3 years. If no responses are seen in the first 10 patients within a category, accrual in that category will end.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically verified (at original diagnosis) solid tumor that is relapsed or refractory - The following histologies are eligible: Sarcomas: Rhabdomyosarcoma; Ewing's sarcoma Peripheral neuroectodermal tumor (PNET); Osteosarcoma Other soft tissue sarcomas; Brain tumors: Ependymoma; Primitive neuroectodermal tumor (PNET); High grade astrocytoma; Brain stem glioma (histologic verification not required); Neuroblastoma - Measurable disease that can be followed clinically or radiologically required The following not considered measurable: Bone lesions measured by bone scan or bone marrow involvement; Central nervous system disease documented by cerebrospinal fluid cytology; Pleural effusion --Prior/Concurrent Therapy-- - Biologic therapy: Prior bone marrow transplantation allowed: Must have stable engraftment without need for significant blood product support or cytokine therapy; No concurrent immunomodulating agents - Chemotherapy: No prior paclitaxel or docetaxel; At least 2 weeks since chemotherapy (4 weeks since nitrosoureas); No other concurrent cancer chemotherapy - Endocrine therapy: Concurrent corticosteroids allowed for intracranial pressure in brain tumor patients provided patient has been stable for at least 4 weeks; Corticosteroids allowed as pretreatment for docetaxel - Radiotherapy: At least 2 months since extensive radiotherapy, defined as: Craniospinal; Volume greater than 50% of abdominopelvic cavity; Volume greater than one third of lung volume; No concurrent radiotherapy - Surgery: Not specified - Other: No more than 2 prior therapies and fully recovered --Patient Characteristics-- - Age: 21 and under at original diagnosis - Performance status: 0-3 - Life expectancy: Greater than 2 months - Hematopoietic: In the absence of marrow involvement: Absolute neutrophil count at least 1,000/mm3; Platelet count at least 100,000/mm3 (transfusion independent); Hemoglobin at least 9.0 g/dL (transfusion allowed) - With bone marrow involvement: Absolute neutrophil count at least 750/mm3; Red cell and platelet support possible - Hepatic: Bilirubin normal; ALT/AST less than 1.5 times normal; Alkaline phosphatase less than 2.5 times normal - Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or radioisotope glomerular filtration rate at least 60 mL/min - Other: Not pregnant or nursing; Adequate contraception required of fertile women
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TheodoreZwerdling, Study Chair, Children's Cancer Group
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2970
United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
United States
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-3039
United States
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, 94143-0128
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
IWK Health Centre
Halifax, Nova Scotia, B3J 3G9
Canada
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3V4
Canada
Children's Hospital of Orange County
Orange, California, 92868
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Princess Margaret Hospital for Children
Perth, Western Australia, 6001
Australia
Long Beach Memorial Medical Center
Long Beach, California, 90806
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Kaiser Permanente Medical Center-Sacramento
Sacramento, California, 95825
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0752
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Children's Hospital of Columbus
Columbus, Ohio, 43205-2696
United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-3330
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York City, New York, 10016
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Children's Hospital of Denver
Denver, Colorado, 80218
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Additional Information:
Study ID Numbers: CDR0000065008; CCG-0962
Study Start Date: April 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002825
Other Recurrent Childhood Rhabdomyosarcoma Studies:
1. O6-benzylguanine and Carmustine in Treating Children With Refractory CNS Tumors
2. Vinorelbine in Treating Children With Recurrent or Refractory Cancers
3. Docetaxel in Treating Children With Recurrent Solid Tumors
4. High-Dose Chemotherapy Plus Autologous Stem Cell Transplantation Compared With Intermediate-Dose Chemotherapy Plus Autologous Stem Cell Transplantation With or Without Isotretinoin in Treating Young Patients With Recurrent High-Grade Gliomas
5. Combination Chemotherapy in Treating Children With Progressive Brain Tumors
Related Studies:
Other recurrent childhood rhabdomyosarcoma Clinical Trials
Other Nebraska Clinical Trials
Other Omaha Clinical Trials
Docetaxel in Treating Children With Recurrent Solid Tumors
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