MIBG + Chemotherapy for Neuroblastoma

Palo Alto (17 mi)

Overseen byBrian Weiss, MD

Age: < 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Children's Oncology Group

No Placebo Group

Trial Summary

What is the purpose of this trial?This pilot clinical trial studies induction therapy followed by iobenguane I 131 and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma undergoing stem cell transplant, radiation therapy, and maintenance therapy with isotretinoin. Radioisotope therapy, such as iobenguane I 131, releases radiation that kills tumor cells. Drugs used in chemotherapy, such as carboplatin, etoposide phosphate, busulfan, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. A peripheral stem cell transplant may be able to replace blood-forming cells that are destroyed by iobenguane I 131 and chemotherapy. Giving radioisotope therapy, chemotherapy, and peripheral stem cell transplant may kill more tumor cells.

Eligibility Criteria

This trial is for children with high-risk neuroblastoma, a type of cancer. Eligible patients are those newly diagnosed with specific stages of the disease, have certain genetic features like MYCN amplification, and meet age requirements. They should not have had much prior treatment except possibly one round of chemotherapy or emergency radiation. Kidney function tests and heart function must be within acceptable ranges.

Inclusion Criteria

I am older than 18 months and my cancer has unfavorable pathology.

I am over 1 year old with a specific type of stage 2 neuroblastoma.

My kidney function tests are within normal range for my age and gender.

My neuroblastoma is newly diagnosed and classified as stage 4.

My cancer shows a specific genetic change and I am over 1 year old.

My child's bilirubin level is less than or equal to 1.0 mg/dL.

My liver enzymes are within normal limits for my age.

My creatinine level is equal to or less than 1.2 mg/dL, and I am between 10 and 13 years old.

My kidney function is within the normal range for my age and gender.

My bilirubin levels are within the normal range for my age.

My cancer shows a high level of MYCN and I am over 1 year old.

My kidney function, based on creatinine levels, is within the normal range.

I am older than 18 months.

My child's bilirubin level is less than or equal to 0.8 mg/dL.

I have been diagnosed with neuroblastoma or ganglioneuroblastoma.

My bilirubin levels are within the required range for my age.

My condition is newly diagnosed stage 3 neuroblastoma.

Exclusion Criteria

I am breastfeeding but agree to stop if I join the trial.

My child is 12-18 months old with stage 4 neuroblastoma but does not qualify due to favorable factors.

Treatment Details

The study tests induction therapy including iobenguane I-131 (a radioactive drug) plus various chemotherapies followed by stem cell transplant and maintenance therapy with isotretinoin. The goal is to see if this combination can better kill tumor cells in these young patients.

1Treatment groups

Experimental Treatment

Group I: Treatment (131I-MIBG, chemotherapy)Experimental Treatment19 Interventions

See Detailed Description.

Busulfan is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Busulfex for: