131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat
- Conditions
- Neuroblastoma
- Interventions
- Registration Number
- NCT02035137
- Lead Sponsor
- New Approaches to Neuroblastoma Therapy Consortium
- Brief Summary
This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG) and compare their effects on tumor response and associated side effects, to determine if one therapy is better than the other for people diagnosed with relapsed or persistent neuroblastoma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- Patients must be > 24 months and < 30 years of age when registered on study.
- Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than a partial response to standard treatment or persistent neuroblastoma that had at least a partial response to frontline therapy frontline therapy with > 3 residual lesions on end-induction MIBG scan.
- Patients must have evidence of MIBG uptake into tumor at ≥ one site within 4 weeks prior to entry on study and subsequent to any intervening therapy.
- Patients must have adequate heart, kidney, liver and bone marrow function. Patients who have bone marrow disease must still have adequate bone marrow function to enter the study.
- Patients must have a dose of unpurged peripheral blood stem cells is 2.0 x 106 viable CD34+ cells/kg available.
- They have had previous I-131 MIBG therapy
- They have other medical problems that could get much worse with this treatment.
- They are pregnant or breast feeding.
- They have a history of a venous or arterial thrombosis that was not associated to a central line.
- They have active infections such as hepatitis or fungal infections.
- They have active diarrhea.
- They have had an allogeneic stem cell transplant (received stem cell from someone else)
- They can't cooperate with the special precautions that are needed for this trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 131I-MIBG with Vincristine/Irinotecan 131I-MIBG Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG with Vorinostat 131I-MIBG Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. Single-Agent 131I-MIBG 131I-MIBG Single-agent 131I-MIBG (Arm A) 18 mCi/kg 131I-MIBG on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG with Vincristine/Irinotecan Vincristine Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG with Vorinostat Vorinostat Vorinostat / 131I-MIBG (Arm C); vorinostat 180 mg/m2 (maximum dose 400 mg) orally once daily on Days -1 to +12 (14 total doses). 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. 131I-MIBG with Vincristine/Irinotecan Irinotecan Vincristine / irinotecan / 131I-MIBG (Arm B): vincristine 2 mg/m2 (maximum dose 2 mg) intravenously on Day 0; irinotecan 50 mg/m2 (maximum dose 100 mg) intravenously on Days 0 to 4. Patients will also receive diarrhea prophylaxis with cefixime 8 mg/kg/day orally on Days -1 to +6. 131I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15.
- Primary Outcome Measures
Name Time Method Objective Tumor Response After One Course of Therapy 43-50 days from study day 1 To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the three arms. The response evaluation was based on central review (intent to treat analysis). Responders defined as meeting CR/MRD/PR criteria. Response was based on NANT response criteria v1.2 (https://doi.org/10.1002/pbc.26940). RECST 1.1 criteria was used for measurable tumors with PR criteria \> 30% decrease in target tumor size. Curie score was used with PR criteria \> 50% decrease in Curie score. Complete Response- disappearance of all target lesions, Curie score of 0 and no detectable bone marrow disease. Overall Response (OR)=CR+PR.
- Secondary Outcome Measures
Name Time Method Number of Participants With Grade 3 or Greater Non-hematologic Toxicities All toxicities from enrollment through 30 days following end of protocol therapy, an average of 6 months Compare toxicity profiles for grade 3 or greater toxicities associated with each of 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG
Trial Locations
- Locations (14)
Children Hospital of Colorado
🇺🇸Aurora, Colorado, United States
Children's Hospital Boston
🇺🇸Boston, Massachusetts, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Childrens Hospital Los Angeles
🇺🇸Los Angeles, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center
🇺🇸San Francisco, California, United States
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
🇺🇸Atlanta, Georgia, United States
Cincinnati Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Lucile Salter Packer Children's Hospital
🇺🇸Palo Alto, California, United States
University of Chicago, Comer Children's Hospital
🇺🇸Chicago, Illinois, United States
C.S Mott Children's Hospital
🇺🇸Ann Arbor, Michigan, United States
Cook Children's Healthcare System
🇺🇸Fort Worth, Texas, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States