Study on Iobenguane (131-I) and Vorinostat for Treating Recurrent or Progressive High-Risk Neuroblastoma

Sponsor: Jubilant DraxImage Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03561259

Provider View

This clinical trial is testing a combination of Iobenguane (131-I) and Vorinostat to see if it is safe and effective for patients with high-risk neuroblastoma that has returned or is not responding to treatment.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of a treatment combining Iobenguane (131-I) and Vorinostat for patients with high-risk neuroblastoma that has come back or is not responding to previous treatments. The trial involves two treatment courses, with the possibility of a second course if the disease is stable or improving. Participants will be monitored for up to 26 weeks if they receive two treatments, or 16 weeks for one treatment, followed by a 2-year follow-up to check for disease progression and any side effects.

Description

This study, called OPTIMUM, is a Phase II trial that tests the use of Iobenguane (131-I) alone or with Vorinostat in treating neuroblastoma, a type of cancer. It includes patients over 1 year old with high-risk neuroblastoma that has returned or progressed after initial treatment. Participants will receive Iobenguane (131-I) intravenously, and those eligible for combination treatment will also take Vorinostat for 14 days. If the first treatment is successful, a second course may be given after at least 6 weeks. The study lasts up to 26 weeks for two treatments or 16 weeks for one, with a 2-year follow-up to monitor health and disease status.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-risk neuroblastoma that has returned or progressed, and shows up on specific scans.
  • May have had previous Iobenguane (131-I) treatment if it was more than 6 months ago and met certain conditions.
  • All tumors must be visible on specific scans or proven not to be neuroblastoma.
  • Must have enough stored blood stem cells or bone marrow.
  • Males must use contraception and not donate sperm during and after the study.
  • Females of childbearing age must have a negative pregnancy test and use effective birth control.
  • Must be at least 1 year old.
  • Must have a platelet count of at least 50,000/μL without recent transfusions.
  • Must have a minimum oxygen level of 94%.
  • Must have a certain level of white blood cells and liver function.
  • Must have normal thyroid and heart function.
  • Must have a performance status score of at least 50%.
  • Must have recovered from previous treatments.
  • Must have normal blood clotting times.

Exclusion Criteria

  • Recently received antibody-based immunotherapy or not recovered from biological therapy.
  • Had a stem cell transplant less than 12 weeks ago.
  • Had an allogeneic stem cell transplant less than 4 months ago.
  • Received radiation therapy less than 2 weeks ago.
  • History of total body irradiation.
  • Poor kidney function or on dialysis.
  • Pregnant or breastfeeding.
  • Active infections like hepatitis B, C, or HIV.
  • Significant heart, lung, or liver problems.
  • Taking certain medications that affect the heart or blood clotting.

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