23 Participants Needed

Atezolizumab + Chemotherapy for Pediatric Solid Cancers

Recruiting at 6 trial locations
KC
SS
Matthew T Campbell | MD Anderson Cancer ...
Overseen ByMatthew Campbell, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

What is the purpose of this trial?

This trial is a multi-center, non-randomized, open-label Phase I/II study evaluating the feasibility and efficacy of vincristine, irinotecan, temozolomide, and atezolizumab in children with relapsed/refractory solid tumors.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, there are specific washout periods for certain treatments, such as chemotherapy, radiotherapy, and some immunosuppressive medications, before starting the study treatment. It's best to discuss your current medications with the trial team to understand any necessary adjustments.

What data supports the effectiveness of the drug Atezolizumab + Chemotherapy for Pediatric Solid Cancers?

The combination of temozolomide (a component of the treatment) and radiotherapy has been shown to effectively control chemotherapy-induced nausea and vomiting in patients with high-grade glioma, suggesting potential benefits in managing side effects in pediatric solid cancers.12345

Is the combination of Atezolizumab, Irinotecan, Temozolomide, and Vincristine safe for children with solid tumors?

Research shows that the combination of Irinotecan and Temozolomide has been tested in children with solid tumors and found to be generally tolerable, though some patients experienced side effects like diarrhea, low white blood cell counts (neutropenia), and low platelet counts (thrombocytopenia). Vincristine has also been tested in combination with these drugs, and while it can cause side effects, the combination has been used in children with relapsed solid tumors.678910

What makes the drug combination of Atezolizumab, Irinotecan, Temozolomide, and Vincristine unique for pediatric solid cancers?

This drug combination is unique because it includes Atezolizumab, an immunotherapy that helps the immune system fight cancer, alongside a chemotherapy regimen of Irinotecan, Temozolomide, and Vincristine, which have shown effectiveness in treating relapsed or refractory pediatric solid tumors. This combination leverages both the immune system and traditional chemotherapy to target difficult-to-treat cancers.6781112

Research Team

MC

Matthew Campbell, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for children and young adults aged 6 months to 30 years with relapsed or refractory solid tumors, including rhabdomyosarcoma. Participants must have had at least one prior therapy, meet specific health criteria (like organ function tests), agree to use effective contraception if of childbearing potential, and be able to follow the study protocol.

Inclusion Criteria

My neurological condition has been stable for the last week.
Hemoglobin ≥ 90 g/L (9 g/dL)
Serum albumin ≥ 25 g/L (2.5 g/dL)
See 47 more

Exclusion Criteria

You have a history of severe or uncontrolled asthma.
I am on a stable or reducing dose of steroids for my CNS condition, approved by the study lead.
I've had high-dose chemotherapy and stem-cell therapy within the last 3 months.
See 43 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Cohort Treatment

Participants receive vincristine, irinotecan, temozolomide, and atezolizumab to determine feasibility

Up to 2 years
Regular visits as per protocol

RMS Efficacy Cohort Treatment

Participants with rhabdomyosarcoma receive the combination treatment to evaluate efficacy

Up to 2 years
Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

42 days post treatment

Treatment Details

Interventions

  • Atezolizumab
  • Irinotecan
  • Temozolomide
  • Vincristine
Trial OverviewThe VITAS trial is testing a combination of drugs: vincristine, irinotecan, temozolomide, and atezolizumab in pediatric patients. It's an open-label Phase I/II study which means everyone gets the treatment and both safety and effectiveness are being measured.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Rhabdomyosarcoma (RMS) Cohort: Patients with rhabdomyosarcomaExperimental Treatment4 Interventions
Seventeen (17) participants with RMS, including the six participants from the Feasibility Cohort, will be enrolled. At least 8 of the RMS participants must have a tumor that expresses the protein PD-L1. Atezolizumab will be administered in combination with vincristine, irinotecan, and temozolomide for up to 2 years or until the participant experiences disease progression or an unacceptable toxicity.
Group II: Feasibility Cohort: Patients with relapsed or refractory solid tumorsExperimental Treatment4 Interventions
Six (6) participants with relapsed or refractory solid tumor will be enrolled. Atezolizumab will be administered in combination with vincristine, irinotecan, and temozolomide for up to 2 years or until the participant experiences disease progression or an unacceptable toxicity.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Tecentriq for:
  • Melanoma
  • Hepatocellular carcinoma
  • Small cell lung cancer
  • Non-small cell lung cancer
  • Urothelial carcinoma
🇪🇺
Approved in European Union as Tecentriq for:
  • Melanoma
  • Hepatocellular carcinoma
  • Small cell lung cancer
  • Non-small cell lung cancer
  • Urothelial carcinoma

Find a Clinic Near You

Who Is Running the Clinical Trial?

Matthew Campbell

Lead Sponsor

Trials
1
Recruited
20+

University of Texas Southwestern Medical Center

Lead Sponsor

Trials
1,102
Recruited
1,077,000+

Findings from Research

A survey of pediatric oncologists revealed that antiemetics are used 17%, 79%, and 98% of the time for chemotherapy agents associated with mild, moderate, and severe nausea and vomiting, respectively, indicating a strong reliance on antiemetic therapy based on the severity of symptoms.
The choice of antiemetics is primarily influenced by oncologists' personal experiences rather than current literature, which suggests that existing practices may not always align with the best available evidence for managing chemotherapy-induced nausea and vomiting in children.
A survey of antiemetic use in children with cancer.van Hoff, J., Hockenberry-Eaton, MJ., Patterson, K., et al.[2015]
In a study involving 565 pediatric cancer patients undergoing highly emetogenic chemotherapy, palonosetron combined with dexamethasone was found to be highly effective in preventing both acute and delayed chemotherapy-induced nausea and vomiting (CINV).
The 10 μg/kg dose of palonosetron demonstrated superior efficacy in the delayed phase of CINV compared to both the 5 μg/kg palonosetron and ondansetron, with complete response rates of 53.5% versus 39.8% and 32.8%, respectively.
Palonosetron is nonsuperior to ondansetron in acute phase but provides superior antiemetic control in delayed phase for pediatric patients administered highly emetogenic chemotherapy.Tan, J., Wang, S., Liang, X., et al.[2018]
In a study of 30 patients with testicular germ cell tumors undergoing 5-day cisplatin chemotherapy, the combination of palonosetron, aprepitant, and dexamethasone achieved a high complete response rate of 90% for preventing vomiting during the first chemotherapy course.
The antiemetic regimen was well-tolerated, with only mild adverse effects reported, such as hiccups and anorexia, indicating a favorable safety profile for this treatment approach.
Antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor receiving 5-day cisplatin-based combination chemotherapy.Hamada, S., Hinotsu, S., Kawai, K., et al.[2021]

References

A survey of antiemetic use in children with cancer. [2015]
Palonosetron is nonsuperior to ondansetron in acute phase but provides superior antiemetic control in delayed phase for pediatric patients administered highly emetogenic chemotherapy. [2018]
Antiemetic efficacy and safety of a combination of palonosetron, aprepitant, and dexamethasone in patients with testicular germ cell tumor receiving 5-day cisplatin-based combination chemotherapy. [2021]
Palonosetron compared with ondansetron in pediatric cancer patients: multicycle analysis of a randomized Phase III study. [2018]
Combination of Palonosetron, Aprepitant, and Dexamethasone Effectively Controls Chemotherapy-induced Nausea and Vomiting in Patients Treated with Concomitant Temozolomide and Radiotherapy: Results of a Prospective Study. [2018]
Temozolomide and intravenous irinotecan for treatment of advanced Ewing sarcoma. [2018]
Phase I trial of two schedules of vincristine, oral irinotecan, and temozolomide (VOIT) for children with relapsed or refractory solid tumors: a Children's Oncology Group phase I consortium study. [2021]
Phase II study of irinotecan in combination with temozolomide (TEMIRI) in children with recurrent or refractory medulloblastoma: a joint ITCC and SIOPE brain tumor study. [2021]
Phase I. Trial of irinotecan and temozolomide in patients with solid tumors. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Irinotecan in lymphoma, leukemia, and breast, pancreatic, ovarian, and small-cell lung cancers. [2018]
Vincristine, irinotecan, and temozolomide treatment for refractory/relapsed pediatric solid tumors: A single center experience. [2019]
[Irinotecan plus temozolomide in refractory or relapsed pediatric solid tumors]. [2018]