Chemoimmunotherapy for Neuroblastoma

Recruiting in Palo Alto (17 mi)

Overseen byShakeel Modak, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out whether an experimental drug called Hu3F8 can be given with the chemotherapy drugs irinotecan and temozolomide and another drug called GM-CSF. The investigators want to find out if this combination is safe and what effect it has on the participant and the disease.

Eligibility Criteria

This trial is for children and adults with high-risk neuroblastoma, a type of cancer. Participants must have specific stages of the disease, measurable or evaluable disease after prior therapy, and cannot be in complete remission. They can't join if they have severe organ damage, low blood counts, allergies to mouse proteins, active infections or are pregnant/breastfeeding.

Inclusion Criteria

My neuroblastoma is considered high-risk based on its stage and genetic features.

My neuroblastoma diagnosis is confirmed by tissue tests or bone marrow and urine tests.

I have had specific previous treatments under certain conditions.

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Exclusion Criteria

My major organs are functioning well, with no severe issues.

I do not have a severe infection that is threatening my life.

ANC < 500/uL

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Treatment Details

Interventions

GM-CSF (Cytokine)
Hu3F8 (Monoclonal Antibodies)
Irinotecan (Topoisomerase I inhibitors)
Temozolomide (Alkylating agents)

Trial OverviewThe study tests an experimental drug called Hu3F8 combined with chemotherapy drugs irinotecan and temozolomide plus GM-CSF to see if this mix is safe and effective against neuroblastoma.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Hu3F8, Irinotecan/Temozolomide and Sargramostim (HITS)Experimental Treatment4 Interventions

Each cycle consists of four doses of hu3F8, five doses each of irinotecan and temozolomide and five doses of GM-CSF.