Clinical Trials

3 studies in neuroblastoma

1. Isotretinoin With or Without Monoclonal Antibody, Interleukin-2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma Rochester, MN View Summary
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   Isotretinoin With or Without Monoclonal Antibody, Interleukin-2, and Sargramostim Following Stem Cell Transplantation in Treating Patients With Neuroblastoma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   PRIMARY OBJECTIVES: I. Determine if monoclonal antibody Chl4.18 + cytokines + isotretinoin (13-cis-retinoic acid, or RA) improves event free survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR. SECONDARY OBJECTIVES: I. Determine if monoclonal antibody Chl4.18 + cytokines + isotretinoin (13-cis-retinoic acid, or RA) improves overall survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR. II. Determine if immunotherapy + RA improves event free survival and overall survival as compared to RA alone, in the subgroup of high risk INSS Stage 4 neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR. III. In the subgroup of neuroblastoma patients who have achieved a pre-ASCT response of CR, VGPR, or PR, determine if there is a difference between the two randomized regimens in reducing the minimal residual disease (MRD) burden as detected by the following parameters: meta-iodobenylguanidine (MIBG) scan, immunocytology (IC) of blood and bone marrow samples, RT-PCR for tyrosine hydroxylase, PGP 9.5, and MAGE-1 in blood and bone marrow. IV. Determine if change from baseline of MRD as measured by above parameters is associated with event free and overall survival V. Determine whether tumor biology at diagnosis correlates with event-free and overall survival, for either of the randomized regimens. VI. Determine the toxicities of the combination of monoclonal antibody Ch14.18 with cytokines. VII. To explore the relationship between antibody-dependent cellular cytoxicity (ADCC) and EFS. VIII. To determine a descriptive profile of human anti-chimeric antibody (HACA) during immunotherapy. IX. To compare the outcome data of the patients with persistent disease documented by biopsy (Stratum 07) to the historical data for the analogous patients from CCG-3981. X. To determine the variability of 13-cis-retinoic-acid pharmacokinetics and relationship to pharmacogenomic parameters and determine if these levels and/or genetic variations correlate with EFS or systemic toxicity. XI. To further describe and refine the EFS and OS estimates and baseline characteristics for subjects receiving Chl4.18 + cytokines + RA, following cessation of the randomized portion of the study. XII. To further describe the safety and toxicity of Chl4.18 + cytokines + RA under the new administration guidelines implemented following cessation of the randomized portion of the study with focus on: a) number of courses delivered per subject; b) number of dose reductions or stoppage (ch14.18 and/or IL-2); and c) number of toxic deaths. XIII. To determine the potential effect of ch14.18 on cardiac repolarization and to evaluate ch14.18 plasma levels. XIV. To determine if the presence of naturally occurring anti-glycan antibodies correlates with allergic reactions and blood levels of ch14.18. XV. To determine if the genotype of FcR and Kir/Kir-Ligand correlate with EFS. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to pre-autologous stem cell transplantation (ASCT) response (complete vs very good partial vs partial), stem cells received (purged vs unpurged), and frontline chemotherapy (COG-A3973 vs POG 9341/9342 vs COG-ANGL02P1 vs other therapy). A further stratum consists of patients with biopsy-confirmed post-ASCT persistent disease who are also enrolled on COG-A3973 or COG-ANBL0532. These patients are not randomized but assigned to treatment arm II. Patients in the first set of strata are randomized to 1 of 2 treatment arms. ARM I: Beginning on day 67 post-ASCT, patients receive oral isotretinoin twice daily for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may cross over to Arm II provided they have not experienced disease progression and have not received any further anti-neuroblastoma therapy following completion of isotretinoin therapy. ARM II: Beginning on day 56 post-ASCT, patients receive immunotherapy comprising sargramostim (GM-CSF) subcutaneously (SC) or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and monoclonal antibody Ch14.18 IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive interleukin-2 IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral isotretinoin as in arm I beginning on and day 11 of immunotherapy. Patients are followed periodically for 10 years.

   NCT ID:

   NCT00026312

   IRB Number:

   2093-05

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   Who can I contact for additional information about this study?

   Rochester: Carola A. Arndt 507-538-7623
                       
   
   
   

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2. Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma Rochester, MN View Summary
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   Biomarkers in Tumor Tissue Samples From Patients With Newly Diagnosed Neuroblastoma or Ganglioneuroblastoma

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: - Evaluate the factors currently used for risk-group assignment (DNA content, MYCN copy number, and tumor histology) in patients with newly diagnosed neuroblastoma or ganglioneuroblastoma. - Assess the prevalence of 1p, 11q, 14q loss of heterozygosity and gain of 17q; the expression of nerve growth factor and its high affinity (Trk-A) and low affinity (p75^NTR) receptors; and telomerase activity in these patients. - Compare the independent clinical significance of these biological factors with MYCN amplification, International Neuroblastoma Staging system stage, age, and histologic variables in predicting response to treatment or outcome in these patients. - To prospectively analyze the concordance between detection of MYCN amplification in tumor samples and quantitative detection of MYCN DNA in serum, and to analyze the prognostic significance of MYCN amplification as detected in serum samples. - To build a database that includes information regarding the presentation and natural history of neuroblastoma-associated health problems including, but not limited to, opsoclonus myoclonus ataxia (OMA) and/or spinal cord compression. - Maintain a reference bank containing clinically and genetically characterized frozen tumor tissue, tumor DNA and RNA, tumor touch preparations, histology slides and blocks, cell lines, and paired normal DNA obtained at time of diagnosis, second-look surgery, and relapse for future research studies. - Build a database of known biological prognostic factors for patients on therapeutic studies. OUTLINE: This is a multicenter study. Patients are stratified according to International Neuroblastoma Staging System stage (stage 1 vs stage 2A vs stage 2B vs stage 3 vs stage 4 vs stage 4S) and age (under 365 days vs 365 days and over). Tumor samples are obtained at the time of surgery (diagnosis). Tumor samples may also be obtained at the time of second-look surgery and/or relapse. Blood and bone marrow samples are also obtained. MYCN copy number is analyzed by fluorescent in situ hybridization (FISH). Tumor cell ploidy is determined by flow cytometric analysis. Allelic status of 1p36, 11q23, and 14q32 is determined by multiplexed fluorescence polymerase chain reaction (PCR). Real-time quantitative PCR and FISH are used to determine 17q gain. Neurotrophin and neurotrophin receptor expression and the level of telomerase RNA expression is determined by reverse transcription-PCR. Telomerase activity is assessed by a telomeric repeat amplification protocol assay in patients with stage 2 or 4S disease. Patients are followed within 2 weeks and then annually (if not on a concurrent therapeutic study). PROJECTED ACCRUAL: Approximately 10,000 patients will be accrued for this study within 6 years.

   NCT ID:

   NCT00904241

   IRB Number:

   776-01

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   
   

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3. Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors Rochester, MN View Summary
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   Collecting and Storing Blood and Brain Tumor Tissue Samples From Children With Brain Tumors

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   OBJECTIVES: - Collect brain tumor tissue and an accompanying blood sample from pediatric patients with brain tumors treated at Children's Oncology Group institutions. - Provide a repository for long-term storage of specimens from these patients. - Make these specimens available to qualified researchers to understand the biology of pediatric brain tumors. OUTLINE: This is a multicenter study Brain tumor tissue and blood specimens are collected from patients and banked for future study. PROJECTED ACCRUAL: An unlimited number of specimens will be collected.

   NCT ID:

   NCT00919750

   IRB Number:

   1741-05

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   Who can I contact for additional information about this study?

   Rochester: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623
                       
   
   
   

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