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Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma 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 Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma Clinical research trials and Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma 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 Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma. Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma 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 Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma clinical trial. Human subjects often obtain the finest healthcare possible for their Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma 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 > "P" Clinical Trials Conditions > Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma  Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma
Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma
For Condition: recurrent neuroblastoma,disseminated neuroblastoma
Status: Recruiting
Sponsor(s): 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. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining pyrazoloacridine with peripheral stem cell or bone marrow transplantation in treating young patients who have recurrent or refractoryneuroblastoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose, in relation to infusion time, of high-dose pyrazoloacridine followed by autologous hematopoietic stem cell rescue in pediatric patients with recurrent or refractory neuroblastoma. - Determine the dose-limiting toxicity of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine, preliminarily, the antitumor activity of this drug in these patients. OUTLINE: This is a two-stage, dose-escalation study. Patients without adequate cryopreserved hematopoietic stem cells undergo peripheral blood stem cell harvest or bone marrow harvest for autologous stem cells at least 2 weeks before study therapy. Patients receive high-dose pyrazoloacridine (PZA) IV on day 0. - Stage I: Cohorts of 3-6 patients receive escalating doses of PZA at a fixed infusion time until the maximum tolerated dose (MTD) is determined. - Cohorts of 3-6 patients receive PZA at the MTD/hour at escalating infusion times until another MTD is determined. In both stages the MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients receive filgrastim (G-CSF) IV or subcutaneously beginning on day 4 and continuing until blood counts recover. Patients also undergo reinfusion of stem cells over 15-30 minutes on day 4 as needed per protocol. Patients are followed at days 28-35, every 3 months for 3 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed neuroblastoma - Recurrent or refractory disease - Received a prior front-line myeloablative regimen OR medically ineligible for front-line treatment - Less than partial response OR - Progressive disease - Must meet at least 1 of the following criteria: - Histologically confirmed bone marrow disease by bilateral bone marrow aspirate and biopsy - Confirmation by immunocytology alone does not constitute eligibility - Positive uptake at a minimum of one site by iodine I 123 metaiodobenzylguanidine (MIBG) scan* - Measurable disease* - At least 20 mm by CT scan or MRI OR at least 10 mm by spiral CT scan - Must have received at least 1 prior salvage regimen - No CNS parenchymal metastases by CT scan of the head with contrast or MRI of the head with gadolinium - Skull metastases allowed provided they are not associated with an extradural mass NOTE: *Biopsy of the site must demonstrate viable neuroblastoma PATIENT CHARACTERISTICS: Age - 1 to 21 Performance status - Karnofsky 50-100% (over 16 years of age) - Lansky 50-100% (1 to 15 years of age) Life expectancy - At least 2 months Hematopoietic - Absolute neutrophil count at least 750/mm^3 - Platelet count at least 75,000/mm^3 (transfusion independent) - Hemoglobin at least 8 g/dL (transfusion allowed) Hepatic - Bilirubin less than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 3 times ULN Renal - Glomerular filtration rate or creatinine clearance at least 100 mL/min - Creatinine no greater than 1.5 times ULN Cardiovascular - Ejection fraction at least 55% by echocardiogram or MUGA OR - Fractional shortening at least 27% by echocardiogram Pulmonary - No dyspnea at rest - No exercise intolerance - No oxygen requirement Neurologic - No history of seizures - No history of cerebral bleeding or stroke - No acute or chronic CNS disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active infection requiring IV antivirals, antibiotics, or antifungals - Patients on prolonged antifungal therapy allowed provided they are culture-negative and biopsy-negative in suspected residual radiographic lesions PRIOR CONCURRENT THERAPY: Biologic therapy - Recovered from prior immunotherapy - At least 7 days since prior growth factors - At least 2 weeks since prior biologic or immunologic agents - At least 9 months since prior autologous hematopoietic stem cell transplantation (HSCT) - No prior allogeneic HSCT Chemotherapy - See Disease Characteristics - No prior pyrazoloacridine - At least 3 weeks since prior chemotherapy (4 weeks for nitrosoureas) and recovered Endocrine therapy - Not specified Radiotherapy - Recovered from prior radiotherapy - At least 2 weeks since prior small-port radiotherapy to lesions not used for study eligibility - At least 4 weeks since prior radiotherapy to study lesions - At least 6 months since prior craniospinal radiotherapy - At least 6 months since prior radiotherapy to 50% or more of the pelvis - At least 6 months since prior total body irradiation Surgery - Not specified Other - No concurrent antiretroviral therapy for HIV-positive patients
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnnaButturini, Study Chair, Children's Hospital Los Angeles
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Susan Cohn 773-880-4562
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-3039
United States
Recruiting John Perentesis 513-636-8610
University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor, Michigan, 48109-0942
United States
Recruiting Gregory Yanik 734-936-8785
James Whitcomb Riley Hospital for Children *Recruiting*
Indianapolis, Indiana, 46202-5225
United States
Recruiting Terry Vik 317-274-8967
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting Julie Park 206-987-1947
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Anna Butturini 323-669-5687
Children's Hospital Boston *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Lisa Diller 617-735-6000
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Howard Katzenstein 404-727-4451
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting John Maris 215-590-5242
UCSF Comprehensive Cancer Center *Recruiting*
San Francisco, California, 94115
United States
Recruiting Katherine Matthay 415-476-3831
Baylor College of Medicine *Recruiting*
Houston, Texas, 77030
United States
Recruiting Susan Blaney 832-822-1482
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6164
United States
Recruiting Paul Sondel 608-263-9069
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Lisa Diller 617-632-5642
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Clare Twist 650-723-5535
Additional Information:
Study ID Numbers: CDR0000269644; NANT-N2002-01,CHLA-NANT-N2002-01
Study Start Date:
Record last reviewed: January 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00053950
Other Recurrent Neuroblastoma Studies:
1. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
2. Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
3. beta-Glucan and Monoclonal Antibody in Treating Patients With Metastatic Neuroblastoma
4. Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma
5. hu14.18-Interleukin-2 Fusion Protein in Treating Young Patients With Recurrent or Refractory Neuroblastoma
Related Studies:
Other recurrent neuroblastoma Clinical Trials
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Pyrazoloacridine and Stem Cell or Bone Marrow Transplantation in Treating Young Patients With Recurrent or Refractory Neuroblastoma
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