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Biological Therapy and Gene Therapy in Treating Children 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 Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma Clinical research trials and Biological Therapy and Gene Therapy in Treating Children 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 Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma. Biological Therapy and Gene Therapy in Treating Children 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 Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma clinical trial. Human subjects often obtain the finest healthcare possible for their Biological Therapy and Gene Therapy in Treating Children 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 > "B" Clinical Trials Conditions > Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma  Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma
Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma
For Condition: disseminated neuroblastoma,Drug Toxicity,recurrent neuroblastoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cell from growing. Inserting genetic material made in the laboratory into a person's blood cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy and gene therapy in treating children who have recurrent or refractory neuroblastoma.
Details: OBJECTIVES: I. Determine the safety and toxicity of cellular immunotherapy using ex vivo expanded autologous CD8+ cytotoxic T-lymphocyte clones genetically modified to express the CE7R scFvFc:zeta chimeric immunoreceptor and the HyTK selection/suicide gene in children with recurrent or refractory disseminated neuroblastoma. II. Determine the antitumor activity of this regimen in these patients. III. Determine the duration of in vivo persistence of adoptively transferred clones and the effect of interleukin-2 on maintaining the in vivo persistence of these clones. IV. Screen for the development of host anti-scFvFc:zeta and HyTK immune responses in patients treated with this regimen. V. Determine the efficacy of ganciclovir in ablating transferred clones in vivo if toxicity occurs in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients undergo autologous peripheral blood stem cell harvest. CD8+ cytotoxic T-lymphocyte (CTL) clones are isolated, genetically modified to express the CE7R scFvFc:zeta chimeric immunoreceptor and the HyTK selection/suicide gene, and then expanded ex vivo. While the modified CTL clones are being generated, patients each receive an individualized salvage chemotherapy regimen that may consist of one of the following: cyclophosphamide and topotecan; ifosfamide, carboplatin, and etoposide; or another chemotherapy regimen chosen by the patient's primary oncologist. The first cohort of 5 patients receives escalating doses of modified CTL clones IV over 30 minutes on days 0, 14, and 28 in the absence of disease progression or unacceptable toxicity. Each patient begins the series of 3 infusions as soon as an adequate number of modified CTL clones are ready and after the acute side effects of chemotherapy have resolved. In the absence of unacceptable toxicity in the first cohort, the second cohort of 5 patients receives the same treatment as cohort 1 plus interleukin-2 subcutaneously every 12 hours on days 15-24 and 29-38. Patients with unacceptable toxicity receive ganciclovir IV every 12 hours for 14 days (or longer if symptomatic resolution is not achieved in that interval). Patients are followed at day 100 and then periodically thereafter. PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 1 Year/17 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically and/or radiographically proven disseminated neuroblastoma; Recurrent or refractory to first-line therapy as defined by less than complete response to standard induction chemotherapy combined with surgical resection - Histologic verification of neuroblastoma required at original diagnosis - No radiographically detectable CNS involvement - No clinically evident progressive encephalopathy --Prior/Concurrent Therapy-- - Biologic therapy: No other concurrent antibody therapy during or after study; No other concurrent immunotherapy (e.g., interferons, vaccines, or other cellular products) - Chemotherapy: At least 3 weeks since prior standard or experimental chemotherapy and recovered - Endocrine therapy: No concurrent systemic corticosteroids unless specifically for amelioration of toxicity induced by transferred T-cell therapy - Radiotherapy: Not specified - Surgery: Not specified - Other: At least 3 weeks since prior immunosuppressive therapies and recovered; No concurrent pentoxifylline; No other concurrent investigational agents; No concurrent ganciclovir, any ganciclovir derivatives, or acyclovir for non-life-threatening herpes virus infections --Patient Characteristics-- - Age: 1 to 17 (children only) - Performance status: Not specified - Life expectancy: At least 3 months - Hematopoietic: Not specified - Hepatic: Not specified - Renal: No dialysis dependency - Cardiovascular: No uncontrolled cardiac arrhythmia; No hypertension requiring pressor support - Pulmonary: No requirement for supplemental oxygen unless expected to resolve within 2 weeks - Neurologic: See Disease Characteristics; No refractory seizure disorder - Other: No detectable human antimouse antibody reactivity if received prior murine antibody preparations; No history of ganciclovir allergy or intolerance; HIV negative; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for at least 2 months after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JuliePark, Study Chair, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Additional Information:
Study ID Numbers: CDR0000068310; FHCRC-1524.00,NCI-H00-0065
Study Start Date: May 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006480
Other Disseminated Neuroblastoma Studies:
1. Interleukin-12 and Interleukin-2 in Treating Patients With Refractory or Recurrent Neuroblastoma
2. Antineoplaston Therapy in Treating Patients With Metastatic, Recurrent, or Refractory Neuroblastoma
3. Combination Chemotherapy, Radiation Therapy, and Stem Cell Transplantation in Treating Patients With Neuroblastoma
4. Melphalan and Buthionine Sulfoximine Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Neuroblastoma
5. Decitabine, Doxorubicin, and Cyclophosphamide in Treating Children With Relapsed or Refractory Solid Tumors or Neuroblastoma
Related Studies:
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Biological Therapy and Gene Therapy in Treating Children With Recurrent or Refractory Neuroblastoma
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