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Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma Clinical research trials and Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma clinical trial. Participants frequently get the best healthcare available for their Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma  Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
For Condition: unspecified childhood solid tumor, protocol specific,recurrent neuroblastoma
Status: Recruiting
Sponsor(s): Children's Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as decitabine, doxorubicin, and cyclophosphamide, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining decitabine with doxorubicin and cyclophosphamide in treating children who have relapsed or refractorysolid tumors or neuroblastoma.
Details: OBJECTIVES: Primary - Determine the maximum tolerated dose of decitabine in combination with doxorubicin and cyclophosphamide in children with relapsed or refractory solid tumors or neuroblastoma. - Determine the toxic effects of this regimen in these patients. - Determine whether decitabine induces tumor caspase-8 demethylation and expression in these patients. Secondary - Determine the pharmacokinetics of low-dose decitabine in these patients. - Determine the biological and clinical response in patients treated with this regimen. - Compare patterns of peripheral blood gene expression, using gene expression profiling, in patients before and after treatment with decitabine. OUTLINE: This is a multicenter, dose-escalation study of decitabine. - Patients receive decitabine IV over 1 hour on days 0-6 and doxorubicin IV over 15 minutes and cyclophosphamide IV over 1 hour on day 7. Patients then receive filgrastim (G-CSF) subcutaneously beginning on day 8 and continuing until blood counts recover. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of decitabine 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 toxicity. - Part B (neuroblastoma patients): Once the MTD is determined for part A, patients are treated as in part A at the MTD . Patients are followed at 30 days. PROJECTED ACCRUAL: A total of 15-21 patients will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of either of the following: - Solid tumor (part A) - No lymphoma - Neuroblastoma (part B) - Original diagnosis may be based on elevated urine vanillylmandelic acid (VMA) and homovanillic acid (HVA) and bone marrow examination - Accessible disease by bone marrow aspirate or tumor biopsy - No laparotomy, thoracotomy, endoscopy, or craniotomy for biopsy - No known curative therapy OR therapy proven to prolong survival with an acceptable quality of life available - No known brain or spinal cord metastases - No CNS tumors PATIENT CHARACTERISTICS: Age - Over 12 months to 21 years Performance status - Karnofsky 50-100% (patients 11 to 21 years of age) - Lansky 50-100% (patients 10 years of age) Life expectancy - Not specified Hematopoietic - Parts A and B without bone marrow infiltration: - Absolute neutrophil count 1,000/mm^3 - Platelet count 100,000/mm^3 (transfusion independent) - Part B with bone marrow infiltration (i.e., tumor metastatic to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia): - Absolute neutrophil count 750/mm^3 - Platelet count 50,000/mm^3 (transfusion independent) - Hemoglobin 8.0 g/dL (transfusion allowed) - No sickle cell anemia Hepatic - Bilirubin 1.5 mg/dL - ALT 5 times upper limit of normal - No significant hepatic dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results Renal - Creatinine based on age as follows: - 0.8 mg/dL (5 years of age and under) - 1.0 mg/dL (6 to 10 years of age) - 1.2 mg/dL (11 to 15 years of age) - 1.5 mg/dL (16 to 21 years of age) OR - Creatinine clearance or radioisotope glomerular filtration rate 70 mL/min - No significant renal dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results Cardiovascular - Shortening fraction 28% by echocardiogram OR - Ejection fraction of 45% by MUGA Pulmonary - No significant pulmonary dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior allergic reaction attributed to compounds of similar chemical or biological composition to agents used in this study - No uncontrolled serious infection - No significant end-organ dysfunction that would compromise the tolerability of decitabine or interfere with study procedures or results PRIOR CONCURRENT THERAPY: Biologic therapy - Recovered from prior immunotherapy - At least 7 days since prior biologic therapy - More than 1 week since prior growth factor therapy (2 weeks for pegfilgrastim) - More than 2 weeks since prior epoetin alfa - At least 6 months since prior autologous stem cell transplantation - At least 6 months since prior allogeneic bone marrow transplantation - Patients must have full organ recovery and no evidence of graft-versus-host disease - No concurrent immunomodulating agents - No concurrent immunotherapy - No concurrent biologic therapy - No concurrent epoetin alfa Chemotherapy - Recovered from prior chemotherapy - More than 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) - Prior total lifetime cumulative anthracycline dose 450 mg/m^2 of doxorubicin or equivalent - No other concurrent chemotherapy - No concurrent hydroxyurea Endocrine therapy - Not specified Radiotherapy - Recovered from prior radiotherapy - More than 2 weeks since prior local palliative small port radiotherapy - More than 6 months since prior substantial bone marrow irradiation (e.g., cranio-spinal irradiation, total body irradiation, or hemi-pelvic irradiation) - No concurrent radiotherapy Surgery - Not specified Other - No other concurrent anticancer therapy - No other concurrent investigational agents - Concurrent oral iron supplementation for patients with a known iron deficiency or a microcytic hypochromic anemia allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RaniGeorge, , Dana-Farber/Harvard Cancer Center
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Gary Houten Dahl 650-497-8238
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Regina Jakacki 412-692-5055
Hopital Sainte Justine *Recruiting*
Montreal, Quebec, H3T 1C5
Canada
Recruiting Mark Bernstein 514-345-4969
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Brenda Weigel 612-626-8484
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting James Croop 317-278-4822
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Ronald Dubowy 315-464-5294
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Sylvain Baruchel 416-813-7795
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Adamson 215-590-5448
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Wayne Furman 901-495-3300
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting John Holcenberg 206-987-2106
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting Dale Pullen 601-984-5220
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Mitchell Cairo 212-305-8316
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Paul Gaynon 323-669-2163
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2916
United States
Recruiting Anne Angiolillo 202-884-2800
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Carola Arndt 507-284-4822
Doernbecher Children's Hospital at Oregon Health & Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting H. Nicholson 503-494-1543
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-2899
United States
Recruiting Robert Wells 513-636-4200
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Holcombe Grier 617-632-3971
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9063
United States
Recruiting Naomi Winick 214-648-3074
Additional Information:
Study ID Numbers: CDR0000347393; COG-ADVL0215
Study Start Date:
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075634
Other Unspecified Childhood Solid Tumor, Protocol Specific Studies:
1. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
2. Docetaxel in Treating Children With Recurrent Solid Tumors
3. Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma
4. Multiple Therapies in Treating Patients With Advanced Neuroblastoma
5. Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma
Related Studies:
Other unspecified childhood solid tumor, protocol specific Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
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