Description:
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.
Title
- Brief Title: 131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinistat
- Official Title: NANT 2011- 01: Randomized Phase II Pick the Winner Study of 131I-MIBG, 131I-MIBG With Vincristine and Irinotecan, or 131I-MIBG With Vorinostat for Resistant/Relapsed Neuroblastoma
Clinical Trial IDs
- ORG STUDY ID:
N2011-01
- NCT ID:
NCT02035137
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Vincristine | | 131I-MIBG with Vincristine/Irinotecan |
Irinotecan | | 131I-MIBG with Vincristine/Irinotecan |
Vorinostat | Zolinza | 131I-MIBG with Vorinostat |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Single-Agent 131I-MIBG | Active Comparator | 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 | Active Comparator | 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. 31I-MIBG, 18 mCi/kg on Day 1 and autologous stem cell infusion on Day 15. | |
131I-MIBG with Vorinostat | Active Comparator | 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. | |
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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 diarhhea.
- 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.
Maximum Eligible Age: | 30 Years |
Minimum Eligible Age: | 2 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective tumor response |
Time Frame: | 43-50 days from study day 1 |
Safety Issue: | |
Description: | To identify the MIBG treatment regimen associated with the highest overall response rate after one course of treatment on the following three arms: single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG. |
Secondary Outcome Measures
Measure: | Delayed engraftment |
Time Frame: | 43-71 days after study day 1. |
Safety Issue: | |
Description: | To compare toxicity profiles associated with occurence of delayed engraftment defined as failure to achieve ANC >= 500/uL by day 43 and platelet count >= 20,000 by day 71 of protocol therapy in absence of progressive bone marrow metastatic disease for each of the following 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG. |
Measure: | Occurence of toxic death |
Time Frame: | Days 43 to 50 after study day 1 |
Safety Issue: | |
Description: | To compare the occurence of toxic deaths for each of the following 131I-MIBG treatment regimens; single-agent 131I-MIBG; Vincristine/Irinotecan/131I-MIBG; or Vorinostat/131I-MIBG. |
Measure: | Grade 3 or greater non-hematologic toxicities |
Time Frame: | day 43 - 50 after study day 1 |
Safety Issue: | |
Description: | 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 |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | New Approaches to Neuroblastoma Therapy Consortium |
Last Updated
January 20, 2021