Neoplasms

All Conditions

Symptoms and General Pathology

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Carcinoma

Recurrence

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Mouth Neoplasms

Oral Cancer

Laryngeal Cancer

Hypopharyngeal Cancer

Sinus Cancer

Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.

Patients with Advanced Head and Neck Cancer Cancer will receive Antineoplaston therapy (Atengenal + Astugenal).

The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Antineoplaston therapy (Atengenal + Astugenal)

Stanislaw R. Burzynski, MD, PhD

Current therapies for advanced Head and Neck Cancer provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of advanced Head and Neck Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Head and Neck Cancer.

Advanced Head and Neck Cancer patients receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues up to12 months in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with advanced Head and Neck Cancer, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in patients with advanced Head and Neck Cancer.
* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer

Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Head and Neck

Burzynski Research Institute

Antineoplastic Agents

All Drugs and Chemicals

Cisplatin

Cisplatinum 100mg/m2 on days 1, 22 and 43, with conventional RT 70 Gy in 7 weeks

Cisplatinum, 100 mg/m2 on days 1, 22 and 43 with adaptive high dose RT to 84 Gy max on 50% uptake GTV in 7 weeks

i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy

cisplatinum

conventional radiotherapy, 70Gy in 7 weeks

Conventional radiotherapy

adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks

Adaptive radiotherapy

Olga Hamming-Vrieze, MD

This Phase III trial aims to:

Explore the impact of pre-treatment information and radiation dose redistribution on locoregional control in patients with locally advanced SCCHN.

The dose to the primary tumor with margins, based upon PET and CT information, will be inhomogeneously increased to a tumor dose between 70 and 84 Gy with decreasing dose towards the edges of the irradiated area.

To determine the toxicity of combined modality treatment (cisplatin) with standard dose distribution versus combined modality treatment (cisplatin) with adaptive inhomogeneous radiation dose distribution.

Adaptive Radiation Treatment for Head and Neck Cancer

Phase III Randomized Study With Cisplatinum and Conventional or Adaptive High Dose Radiotherapy for Advanced Head and Neck Cancer

Karolinska Institutet

Maastricht Radiation Oncology

Institut Catala de Salut

The Christie NHS Foundation Trust

Gustave Roussy, Cancer Campus, Grand Paris

UMC Utrecht

European Union

The Netherlands Cancer Institute

Apatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Xiaohui He, B.D.

Lin Gui, M.D.

In this study, the investigators try to evaluate the efficacy and safety of apatinib in advanced non-squamous head and neck cancer and to validate the correlative biomarkers.

There is no standard therapy for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer. Apatinib is a novel vascular endothelial growth factor receptor 2 tyrosine kinase inhibitor, which has been approved for the treatment of patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Vascular endothelial growth factor is highly expressed in non-squamous head and neck cancer and its expression correlates with stage, tumour size, vascular invasion, recurrence and metastasis. In this study, the investigators try to evaluate the efficacy and safety of apatinib in advanced non-squamous head and neck cancer and to validate the correlative biomarkers.

Apatinib for Advanced Non-squamous Head and Neck Cancer

The Clinical Study of Apatinib for Patients With Advanced Non-squamous Head and Neck Cancer

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Professor

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Neoplasms, Squamous Cell

Herbal and Botanical

Docetaxel

Taxane

Tubulin Modulators

Antimitotic Agents

Grapefruit Seed Extract

Participants will receive duvelisib by mouth twice daily,dosage per protocol continuously (days 1-21 of a 21-day cycle) with a 7-day lead-in planned prior to the start of taxane therapy.

Docetaxel at via IV will be delivered on day 1 of each 21-day cycle.

Treatment will continue for 24-months or until unacceptable toxicity, progression, or death.

Duvelisib capsules should be swallowed whole with a glass of water (approximately 8 ounces).

Advise patients not to open, break, or chew the capsules. Duvelisib may be administered without regard to meals; however, subjects should avoid grapefruit and grapefruit juice while on duvelisib.

continue for up to 24 months.

Duvelisib

Docetaxel chemotherapy once every 21 days (by intravenous infusion) over about 30- 60 minutes at each visit. This will continue for up to 24 months

Glenn J. Hanna, MD

This trial that is investigating a medication called duvelisib in combination with docetaxel for the treatment of squamous cell carcinoma of the head and neck (SCCHN) that has returned or spread outside the head and neck area.

The names of the study drugs involved in this study are:

* Duvelisib (PI3K inhibitor)
* Docetaxel chemotherapy

This multicenter, phase II open-label, single-arm trial will enroll participants with recurrent or metastatic (R/M), incurable squamous cell carcinoma of the head and neck (SCCHN) who have failed or discontinued PD-1 blockade in the first-line (1L) advanced disease setting, regardless of human papillomavirus (HPV) and smoking status, or PI3K pathway alteration status.

This research study involves the oral (taken by mouth) agent duvelisib with the intravenous (IV) chemotherapy agent docetaxel.

The names of the study drugs involved in this study are:

* Duvelisib (PI3K inhibitor)
* Docetaxel chemotherapy

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

Participants will receive study treatment for up to 2 years and will be followed for 3 years.

It is expected that about 30 people will take part in this research.

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug (duvelisib) to learn whether it works in treating a specific disease. "Investigational" means that the drug is being studied.

The U.S. Food and Drug Administration (FDA) has not approved duvelisib for this specific disease but has approved it for other uses (such as certain types of blood cancers). The FDA has approved docetaxel as a treatment option for head and neck cancer, as well as other cancer types.

Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC

A Phase II Study of Duvelisib Plus Docetaxel in PD-1 Inhibitor Experienced Patients With Incurable Head and Neck Squamous Cell Carcinoma

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Measured with RECIST v 1.1

Overall Survival (OS) is defined as the time from registration to death due to any cause, or censored at date last known alive

Progression-Free Survival (PFS) is defined as the time from registration to the earlier of progression or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation.

The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause. Participants without events reported are censored at the last disease evaluation).

NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Secura Bio, Inc.

Glenn J. Hanna

Sponsor Investigator

Paclitaxel

Albumin-Bound Paclitaxel

rAd-p53 tumor injection combined with radio- and chemo-therapy.

multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10\^12 viral particles (VP) in a 21-days cycle.

rAd-p53

radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.

radiation

Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15

Xia He, MD, PhD

Jianfeng Wu, MD, PhD

The objectives of this study are to investigate the efficacy and safety of rAd-p53 gene combined with radio- and chemo-therapy vs. radio- and chemo- therapy only in treatment of unresectable, locally advanced head and neck cancer. This is a phase 2, open labeled, and active-controlled study.

To evaluate benefits of rAd-p53) gene therapy combined with radio- and chemo-therapy in treatment of unresectable, locally advanced head and neck cancer, total of 60 patients with above condition will be randomly assigned to two groups: the experiment group (EG) and the control group (CG). The EG received multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10\^12 viral particles (VP) in a 21-days cycle. Both EG and CG were given radiotherapy at a total dose of 60 Gy and chemotherapy (Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15). The patients will be treated until disease progression, withdrawal from study, or untolerated adverse events. study endpoints are efficacy (Progression-free survival, overall survival) and safety variables.

P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer

Recombinant Adenoviral Human p53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable, Locally Advanced Head and Neck Cancer - a Open-labeled Randomized Phase 2 Study

Patients will be followed up until progression or death, withdrawal from study, or until data cut-off after 3 years.

Patients will be followed up until death, withdrawal from study, or until data cut-off after 3 years.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer	NCT00003489	Head and Neck C...	Antineoplaston ...	16 Years - 99 Years	Burzynski Research Institute
Adaptive Radiation Treatment for Head and Neck Cancer	NCT01504815	Head and Neck C...	cisplatinum Conventional ra... Adaptive radiot...	18 Years - 70 Years	The Netherlands Cancer Institute
Antineoplaston Therapy in Treating Patients With Advanced Head and Neck Cancer	NCT00003489	Head and Neck C...	Antineoplaston ...	16 Years - 99 Years	Burzynski Research Institute
Adaptive Radiation Treatment for Head and Neck Cancer	NCT01504815	Head and Neck C...	cisplatinum Conventional ra... Adaptive radiot...	18 Years - 70 Years	The Netherlands Cancer Institute
Apatinib for Advanced Non-squamous Head and Neck Cancer	NCT02989259	Head and Neck N...	Apatinib	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Duvelisib Plus Docetaxel In Recurrent/Metastatic HNSCC	NCT05057247	Squamous Cell C... Recurrent Squam... Metastatic Head... Advanced Head a... Advanced Head a...	Duvelisib Docetaxel	18 Years -	Dana-Farber Cancer Institute
P53 Gene Combined With Radio- and Chemo-therapy in Treatment of Unresectable Locally Advanced Head and Neck Cancer	NCT02429037	Advanced Head a...	rAd-p53 radiation Cisplatin	18 Years -	Shenzhen SiBiono GeneTech Co.,Ltd

Spots Global Cancer Trial Database for advanced head and neck cancer