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Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed 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 using a real mD. We aren't mDs. Always confer with your physician on Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors Clinical research trials and Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors. Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors clinical trial. Human subjects often receive the most effective healthcare possible for their Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "O" Clinical Trials Conditions > Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors  Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors
Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors
For Condition: cardiac toxicity,unspecified childhood solid tumor, protocol specific
Status: Suspended
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of doxorubicin and cyclophosphamide by making the tumor cells more sensitive to the drug. Chemoprotective drugs such as dexrazoxane may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase I trial to study the effectiveness of oblimersen plus combination chemotherapy and dexrazoxane in treating children and adolescents who have relapsed or refractory solid tumors.
Details: OBJECTIVES: - Determine the dose-limiting toxic effects and recommended phase II dose of oblimersen when combined with cyclophosphamide, doxorubicin, and dexrazoxane in pediatric patients with relapsed or refractory solid tumors. - Determine the pharmacokinetic behavior of this regimen in these patients. - Determine, preliminarily, the antitumor activity of oblimersen in these patients. - Assess the biologic activity of oblimersen in mononuclear cells and tumor tissues, in terms of bcl-2 and related protein expression, in these patients. OUTLINE: This is a multicenter, dose-escalation study of oblimersen. Patients receive oblimersen IV continuously on days 1-7. Patients also receive dexrazoxane IV followed by doxorubicin IV over 15 minutes followed by cyclophosphamide IV over 1 hour on days 5 and 6. Filgrastim (G-CSF) is administered subcutaneously once daily beginning on day 8 and continuing until blood counts recover. Treatment repeats every 21 days for up to 18 courses (1 year) in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease whose shortening fraction falls below 28% by echocardiogram or whose total life-time cumulative anthracycline dose exceeds 750 mg/m^2 may receive additional courses of oblimersen and cyclophosphamide without doxorubicin and dexrazoxane. Cohorts of 3-6 patients receive escalating doses of oblimersen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 15-18 patients will be accrued for this study within 7.5-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed solid tumor at original diagnosis that has failed standard therapy or for which no standard therapy exists - Patients must have a disease for which there is no known curative potential - Patients must meet the following criteria for bone marrow function: - Status post stem cell transplantation (SCT) - Absolute neutrophil count at least 1,000/mm^3 - Platelet count at least 100,000/mm^3 (transfusion independent) - Hemoglobin at least 8.0 g/dL (RBC transfusions allowed) - No lymphomas - No CNS tumors or known metastatic disease to the brain or spinal cord PATIENT CHARACTERISTICS: Age: - 1 to 21 Performance status: - Karnofsky 50-100% (age 11 to 21) - Lansky 50-100% (age 1 to 10) Life expectancy: - At least 8 weeks Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT no greater than 3 times ULN - No significant hepatic dysfunction Renal: - Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min OR - Creatinine, based on age, as follows: - Age 1 to 5: no greater than 0.8 mg/dL - Age 6 to 10: no greater than 1.0 mg/dL - Age 11 to 15: no greater than 1.2 mg/dL - Age 16 to 21: no greater than 1.5 mg/dL - No significant renal dysfunction Cardiovascular: - Shortening fraction at least 28% by echocardiogram OR - Ejection fraction at least 45% by MUGA Pulmonary: - No significant pulmonary dysfunction Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No serious uncontrolled infections - No other end-organ dysfunction that would preclude study entry - No other clinically significant systemic illness PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - Recovered from prior immunotherapy - At least 1 week since prior growth factors or other biologic agents - At least 6 months since prior autologous SCT - At least 6 months since prior allogeneic bone marrow transplantation and recovered with no evidence of graft-versus-host disease - No concurrent immunomodulating agents - No concurrent prophylactic growth factors during the first course of the study - No concurrent immunotherapy or other biologic therapy Chemotherapy: - Recovered from prior chemotherapy - At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) - No prior life-time cumulative doxorubicin dose of more than 450 mg/m^2 or equivalent - No other concurrent chemotherapy Endocrine therapy: - Concurrent chronic steroids allowed Radiotherapy: - Recovered from prior radiotherapy - More than 2 weeks since prior localized palliative radiotherapy (small port) - More than 6 months since prior substantial radiotherapy to bone marrow (craniospinal radiotherapy, total body irradiation, or hemi-pelvic radiotherapy) - No concurrent radiotherapy Surgery: - Not specified Other: - Concurrent chronic medications (e.g., narcotics or antiepileptics) allowed - No other concurrent investigational agents - No other concurrent cancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SusanRheingold, Study Chair, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104-4318
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Children's Hospital Los Angeles
Los Angeles, California, 90027-0700
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Texas Children's Cancer Center
Houston, Texas, 77030-2399
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Children's National Medical Center
Washington D.C., District of Columbia, 20010-2916
United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Doernbecher Children's Hospital
Portland, Oregon, 97201-3098
United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
Children's Hospital Medical Center - Cincinnati
Cincinnati, Ohio, 45229-2899
United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, 98105
United States
Additional Information:
Study ID Numbers: CDR0000069387; COG-ADVL0211,NCI-03-C-0202
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039481
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
2. Enalapril in Treating Heart Damage Patients Who Received Anthracycline Chemotherapy for Childhood Cancer
3. Chemotherapy Followed by Radiation Therapy in Treating Young Patients With Newly Diagnosed Hodgkin's Disease
4. Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors
5. Chemotherapy in Treating Women Enrolled in the SWOG-8897 Clinical Trial
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
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Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors
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