Chemotherapy for Recurrent Solid Cancers in Children

Recruiting at 21 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Children's Oncology Group

Must not be taking: Anticoagulants, CYP3A4 inducers

Disqualifiers: Pregnancy, Interstitial lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 21

Duration: Up to 24 months

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of nanoparticle albumin-bound rapamycin when given together with temozolomide and irinotecan hydrochloride in treating pediatric patients with solid tumors that have come back after treatment and a period of time during which the tumor could not be detected or has not responded to treatment. Nanoparticle albumin-bound rapamycin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as temozolomide and irinotecan hydrochloride, 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. Giving nanoparticle albumin-bound rapamycin, temozolomide, and irinotecan hydrochloride may cause the cancer to stop growing or shrink for a period of time and may lessen the symptoms that are caused by the cancer.

Research Team

Stuart L Cramer

Principal Investigator

COG Phase I Consortium

Eligibility Criteria

This trial is for pediatric patients with solid tumors, including brain and CNS tumors that have returned or didn't respond to treatment. They must have a body surface area of at least 0.2 m^2, measurable disease, no known curative therapy available, stable neurologic deficits if present, and recovered from previous cancer treatments. Pregnant or breastfeeding individuals are excluded.

Inclusion Criteria

My nerve-related side effects from previous treatments are mild.

Patients must have a body surface area (BSA) of >= 0.2 m^2 at the time of study enrollment

My condition cannot be cured with current treatments.

Exclusion Criteria

I am on corticosteroids and meet the specific requirements.

I am taking medication that affects how my body processes drugs.

I have a history of severe depression.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nanoparticle albumin-bound rapamycin IV on days 1 and 8, and temozolomide and irinotecan hydrochloride PO on days 1-5, repeating every 21 days for up to 35 cycles

Up to 24 months

Visits every 21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 24 months

Treatment Details

Interventions

• Irinotecan Hydrochloride
• Nanoparticle Albumin-Bound Rapamycin
• Temozolomide

Trial Overview The trial tests nanoparticle albumin-bound rapamycin combined with chemotherapy drugs temozolomide and irinotecan hydrochloride in children. It aims to find the safest dose that can stop tumor growth by blocking necessary enzymes while killing or preventing cancer cells from dividing and spreading.

Participant Groups

Group I: Treatment (nab-rapamycin, temozolomide, irinotecan) Experimental Treatment 5 Interventions

Patients receive nanoparticle albumin-bound rapamycin IV over 30 minutes on days 1 and 8 beginning on cycle 1. Patients also receive temozolomide PO and irinotecan hydrochloride PO on days 1-5 beginning on cycle 2. Treatment repeats every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.

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

Approved in United States as Camptosar for:

• Colorectal cancer
• Pancreatic cancer

Approved in European Union as Irinotecan for:

• Colorectal cancer
• Pancreatic cancer

Approved in Canada as Camptosar for:

• Colorectal cancer
• Pancreatic cancer

Approved in Japan as Irinotecan for:

• Colorectal cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+