10 Participants Needed

Tolinapant + Radiation for Head and Neck Cancer

NF
NC
Overseen ByNicole C Schmitt, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, tolinapant, combined with radiation therapy for head and neck cancer patients who can't use the standard treatment. Tolinapant may block enzymes that help cancer grow, while radiation kills cancer cells.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does exclude certain medications known to cause QT prolongation (a heart rhythm condition). It's best to discuss your current medications with the trial team to see if any adjustments are needed.

What data supports the effectiveness of the treatment Tolinapant + Radiation for Head and Neck Cancer?

The use of advanced radiation techniques like Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT) in head and neck cancer has been shown to improve tumor targeting while reducing damage to normal tissues, leading to better outcomes with fewer side effects. Additionally, combining radiation with systemic therapies, such as platinum-based chemotherapy, is a standard approach that has proven benefits in treating head and neck cancer.12345

Is the combination of Tolinapant and radiation therapy safe for humans?

Radiation therapy can cause nausea and vomiting in many patients, but these side effects can often be managed with antiemetic drugs (medications that prevent nausea and vomiting). The safety of Tolinapant specifically in combination with radiation therapy is not detailed in the provided research, so further information from clinical trials would be needed to assess its safety.678910

What makes the Tolinapant + Radiation treatment unique for head and neck cancer?

The Tolinapant + Radiation treatment is unique because it combines a novel drug, Tolinapant, with advanced radiation techniques like Intensity-Modulated Radiation Therapy (IMRT) and Image-Guided Radiation Therapy (IGRT), which allow for precise targeting of tumors while sparing healthy tissue. This combination aims to improve tumor control and reduce side effects compared to conventional treatments.411121314

Research Team

NC

Nicole C Schmitt, MD

Principal Investigator

Emory University

Eligibility Criteria

Adults with previously untreated, locally advanced head and neck cancer who cannot receive cisplatin. They must be in good physical condition (ECOG ≀1), have acceptable organ function, no severe hearing loss or neuropathy, and not be pregnant or breastfeeding. Participants need to use effective contraception and cannot have a history of significant mental illness or substance abuse.

Inclusion Criteria

I have a confirmed diagnosis of head and neck cancer that hasn't been treated yet, and I can't receive cisplatin with my radiation.
I cannot receive cisplatin due to my age or other health conditions.
I am 18 years old or older.
See 6 more

Exclusion Criteria

Receiving any other investigational agents or device within 21 days before study drugs
History of allergic reactions to compounds similar to tolinapant
I have had radiation therapy to my head or neck.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tolinapant orally and undergo radiation therapy for a total of 35 fractions over 7 weeks

7 weeks
Weekly visits for radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months
Follow-up visits at 1, 3, 6, 12, and 24 months

Treatment Details

Interventions

  • Radiation Therapy
  • Tolinapant
Trial OverviewThe trial is testing the combination of a new drug called Tolinapant with radiation therapy against head and neck cancers that can't be treated with cisplatin. The goal is to see if this combo is safe and more effective at killing cancer cells than standard treatments.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (tolinapant, radiation therapy)Experimental Treatment2 Interventions
Patients undergo standard of care radiation therapy for a total of 35 fractions over 7 weeks and receive tolinapant PO daily for 7 days during weeks 1, 3, 5, and 7 of radiation therapy in the absence of disease progression or unacceptable toxicity.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

πŸ‡ͺπŸ‡Ί
Approved in European Union as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
πŸ‡ΊπŸ‡Έ
Approved in United States as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
πŸ‡¨πŸ‡¦
Approved in Canada as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
πŸ‡―πŸ‡΅
Approved in Japan as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
πŸ‡¨πŸ‡³
Approved in China as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors
πŸ‡¨πŸ‡­
Approved in Switzerland as Radiation Therapy for:
  • Cancer treatment
  • Palliative care
  • Oropharyngeal cancer
  • Breast cancer
  • Prostate cancer
  • Lung cancer
  • Brain tumors

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Astex Pharmaceuticals, Inc.

Industry Sponsor

Trials
97
Recruited
7,400+

Dr. Harren Jhoti

Astex Pharmaceuticals, Inc.

Chief Executive Officer since 2007

PhD in Biochemistry from Birkbeck College, London

Dr. Harold N. Keer

Astex Pharmaceuticals, Inc.

Chief Medical Officer since 2020

MD

Findings from Research

Induction therapy with docetaxel, cisplatin, and 5-fluorouracil (TPF) before chemoradiotherapy significantly increased the rate of complete radiologic response (CR) in patients with locally advanced squamous cell carcinoma of the head and neck, achieving a CR rate of 50% compared to 21.2% for chemoradiotherapy alone.
Patients receiving TPF followed by chemoradiotherapy also experienced longer median progression-free survival (30.4 months vs. 19.7 months) and overall survival (39.6 months vs. 33.3 months) without an increase in toxic effects, indicating that TPF is both effective and safe.
Concomitant chemoradiotherapy versus induction docetaxel, cisplatin and 5 fluorouracil (TPF) followed by concomitant chemoradiotherapy in locally advanced head and neck cancer: a phase II randomized study.Paccagnella, A., Ghi, MG., Loreggian, L., et al.[2020]
Methotrexate and cisplatin are still the standard chemotherapy agents for patients with recurrent head and neck cancer, but neoadjuvant chemotherapy lacks firm evidence for improving survival, though it may help with organ preservation.
Concomitant chemoradiotherapy has shown proven benefits in randomized trials, and while there are promising results from protracted radiation schedules, these need further confirmation through additional randomized studies.
Chemotherapy and integrated treatment approaches in head and neck cancer.Vokes, EE.[2019]
Recent innovations in radiation therapy for head and neck squamous cell carcinoma focus on intensity-modulated radiation therapy (IMRT), which aims to reduce long-term side effects while effectively targeting tumors.
Emerging technologies such as adaptive treatment, dose painting, and proton therapy are being evaluated for their potential to improve treatment outcomes and minimize toxicity in patients with head and neck cancers.
The management of head and neck tumors with high technology radiation therapy.Mendez, LC., Moraes, FY., Poon, I., et al.[2016]

References

Concomitant chemoradiotherapy versus induction docetaxel, cisplatin and 5 fluorouracil (TPF) followed by concomitant chemoradiotherapy in locally advanced head and neck cancer: a phase II randomized study. [2020]
Chemotherapy and integrated treatment approaches in head and neck cancer. [2019]
The management of head and neck tumors with high technology radiation therapy. [2016]
Current strategies in radiotherapy of head and neck cancer. [2021]
The chemotherapy of head and neck cancer. [2019]
Treatment implications for radiation-induced nausea and vomiting in specific patient groups. [2007]
Randomized phase III trial of postoperative radiochemotherapy +/- amifostine in head and neck cancer. Is there evidence for radioprotection? [2013]
Radiation-induced nausea and vomiting in head and neck cancer: Is it something worth considering in the intensity modulated radiotherapy era? "A narrative review". [2021]
Evolution of antiemetic studies for radiation-induced nausea and vomiting within an outpatient palliative radiotherapy clinic. [2021]
Efficacy of granisetron and aprepitant in a patient who failed ondansetron in the prophylaxis of radiation induced nausea and vomiting: a case report. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Target coverage for head and neck cancers treated with IMRT: review of clinical experiences. [2018]
Early clinical outcomes of helical tomotherapy/intensity-modulated proton therapy combination in nasopharynx cancer. [2021]
[Setup margin for head-and-neck cancer patients receiving 2D-2D and 3D image-guided intensity-modulated radiation therapy]. [2018]
14.United Statespubmed.ncbi.nlm.nih.gov
Dosimetric comparison of intensity modulated radiotherapy and intensity modulated proton therapy in the treatment of recurrent nasopharyngeal carcinoma. [2022]