Isotretinoin +/- Immunotherapy for Neuroblastoma

Recruiting in Palo Alto (17 mi)

+208 other locations

Overseen byAlice L Yu

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.

Research Team

Alice L Yu

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for patients with high-risk neuroblastoma who have completed intensive induction, stem cell transplant, and radiotherapy. Eligible participants must not have had prior anti-GD2 antibody therapy, should be able to perform daily activities at least half of the time (>=50% performance score), expect to live more than 2 months, and have adequate organ function. They must also agree to use birth control if applicable and cannot be breastfeeding.

Inclusion Criteria

My heart's pumping ability is confirmed to be normal by recent tests.

I have high-risk neuroblastoma, or it became high-risk after initial diagnosis.

I completed therapy for my cancer, including intensive treatment and a stem cell transplant.

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Treatment Details

Interventions

Aldesleukin (Cytokine)
Dinutuximab (Monoclonal Antibodies)
Isotretinoin (Retinoid)
Sargramostim (Cytokine)

Trial OverviewThe study tests whether adding dinutuximab (a monoclonal antibody), aldesleukin (stimulates white blood cells), and sargramostim (boosts immune system) to isotretinoin chemotherapy improves outcomes in neuroblastoma post-stem cell transplant compared to isotretinoin alone. It's a phase III trial where some patients are randomly chosen to receive the additional drugs.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm II (sargramostim, dinutuximab, aldesleukin, isotretinoin)Experimental Treatment7 Interventions

Beginning preferably between day 56 and day 85 post-ASCT, but may be delayed up to day 200, patients receive immunotherapy comprising sargramostim SC or IV over 2 hours on days 0-13 during courses 1, 3, and 5 and dinutuximab IV over 10-20 hours on days 3-6 of courses 1-5. Patients also receive aldesleukin IV continuously on days 0-3 and 7-10 during courses 2 and 4. Immunotherapy repeats every 28 days for 5 courses in the absence of disease progression or unacceptable toxicity. Patients also receive isotretinoin as in Arm I beginning on day 11 of immunotherapy.

Group II: Arm I (isotretinoin) (closed to accrual as of 4/16/2009)Active Control4 Interventions

Beginning preferably between day 56 and day 85 post-ASCT, but may be delayed up to day 200, patients receive isotretinoin PO BID for 14 days. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients may cross over to Arm II provided they have not experienced disease progression and have not received any further anti-neuroblastoma therapy following completion of isotretinoin therapy.