MIBG + Chemotherapy for Neuroblastoma

Recruiting in Palo Alto (17 mi)

+33 other locations

Overseen byBrian D Weiss

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.

Research Team

Brian D Weiss

Principal Investigator

Children's Oncology Group

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

Shortening fraction >= 27% by echocardiogram or

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.

See 22 more

Exclusion Criteria

I haven't had high-dose radiation to my kidneys or liver.

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

Females of childbearing potential must have a negative pregnancy test; patients of childbearing potential must agree to use an effective birth control method

See 1 more

Treatment Details

Interventions

Busulfan (Chemotherapy)
Cyclophosphamide (Chemotherapy)
Etoposide Phosphate (Chemotherapy)
Iobenguane I-131 (Radioisotope Therapy)
Isotretinoin (Retinoid)
Melphalan (Chemotherapy)

Trial OverviewThe 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.

Participant Groups

1Treatment groups

Experimental Treatment

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

See Detailed Description.

Busulfan is already approved in Canada, Japan for the following indications: