Combination Chemotherapy for Neuroblastoma

Recruiting in Palo Alto (17 mi)

Brian H. Kushner, MD - MSK Pediatric ...

Overseen byBrian Kushner, MD

Age: < 65

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 the study is to find out whether N9 is a safe and effective treatment for children with neuroblastoma. N9 includes 3 different combinations of chemotherapy drugs that are given at different times - Cyclophosphamide, topotecan, and vincristine (CTV), Ifosfamide, carboplatin, and etoposide (ICE), Cyclophosphamide, doxorubicin, and vincristine (CDV).

Research Team

Brian Kushner, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for children aged 1 to less than 13 with neuroblastoma, who have had no more than one prior chemo treatment. They must have a certain level of heart function and kidney function, as well as adequate liver function. Children with severe organ dysfunction or inability to follow the study plan cannot participate.

Inclusion Criteria

Signed informed consent indicating awareness of the investigational nature of this treatment

My neuroblastoma diagnosis is confirmed by specific tests and criteria.

I have had only one round of chemotherapy.

See 2 more

Exclusion Criteria

I do not have severe problems with my kidneys, heart, liver, brain, lungs, blood, or stomach.

I am a pre-adolescent, so pregnancy is not applicable.

Inability to comply with protocol requirements

Treatment Details

Interventions

Carboplatin (Alkylating agents)
Cyclophosphamide (Alkylating agents)
Doxorubicin (Anti-tumor antibiotic)
Etoposide (Topoisomerase I inhibitors)
Ifosfamide (Alkylating agents)
Topotecan (Topoisomerase I inhibitors)
Vincristine (Vinca alkaloids)

Trial OverviewThe N9 study tests three combinations of chemotherapy drugs (CTV, ICE, CDV) in cycles to determine their safety and effectiveness against pediatric neuroblastoma. Each drug combo includes agents like Cyclophosphamide and Doxorubicin known for treating cancer.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Participants with newly-diagnosed HR-NeuroblastomaExperimental Treatment8 Interventions

This pilot study of N9 as induction chemotherapy will enroll 30 patients with newly-diagnosed HR-NB. A first cohort of \>1 to 12-year old, and a second cohort of extended age \<19 years old. Both cohorts will be analyzed together.

Carboplatin is already approved in Canada for the following indications: