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Head and Neck Squamous CarcinomaPhase 1NCT04361409

Rituximab Plus Chemotherapy in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

A Phase 1 study testing Rituximab, Cisplatin and Gemcitabine in people with Head and Neck Squamous Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Head and neck squamous cell carcinoma (HNSCC) is an important disease with the incidence of 6th all over the world. In Taiwan it is the fifth of male cancer mortality. Most of the patients were middle age and the impact for economy and society was incredible. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Head and Neck Squamous Carcinoma
What is being tested?
Rituximab, Cisplatin and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteTaiwan
Study dates
May 2013to Jan 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed squamous cell carcinoma of head and neck.
  • Locoregional recurrence and/or metastases after primary curative local treatment and unsuitable for further radiotherapy and surgery; or primary distant metastases at diagnosis.
  • Measurable disease. Defined as presence of at least one lesion as being ≥10 mm in at least one dimension measured with conventional computed tomography (CT) or ≥10 mm in at least one dimension measured with spiral CT scan or magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group performance status ≤2;
  • Age between 20 and 65 years; and life expectancy of at least 12 weeks.
  • Prior treatments with radiation therapy for palliative management of non-target lesion metastatic disease is permitted provided that at least 2 weeks have relapsed since the last fraction of radiation therapy, disease progression has been documented and all treatment related adverse events are ≦ grade 1 at the time of registration.
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  • Negative pregnancy test, Fertile patients must use effective contraception
  • No history of allergic reactions attributed to Rituximab/cisplatin/gemcitabine
  • Patient consent must be obtained

Who cannot join

  • Presence of central nervous system (CNS) metastases;
  • Presence of other malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ prior to entry into the study
  • Presence of bone-only metastasis
  • The organ function measured within 14 days prior to study entry as defined below: White blood cell (WBC) less than 2,000/mm3, absolute neutrophil count (ANC) less than 1,500/mm3, or platelets less than 100,000/mm3; serum bilirubin greater than 1.5 times the upper limit of normal range (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases, or greater than 5 times the ULN in the presence of liver metastases; creatinine clearance ≤60 ml/min (based upon urine collection);
  • Concomitant illness including uncontrolled infection or other active, uncontrolled disease such as congestive heart failure, angina pectoris, respiratory insufficiency, and arrhythmia.
  • Documented hypersensitivity to platinum compounds or compounds of similar chemical or biologic composition
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  • Pregnant or lactating women.
  • Under rituximab treatment or have ever received rituximab within six months.
  • Ongoing other concurrent investigational agents or anticancer therapy

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • China medical University hospital

    Taichung, 404

Other trials in Taiwan

About this study

Official title: A Phase I Pilot Study of B Cell Depletion With Rituximab Following by Chemotherapy With Cisplatin Plus Gemcitabine for Recurrent Unresectable or Metastatic Head and Neck Cancer Squamous Cell Carcinoma Patients.

Head and neck squamous cell carcinoma (HNSCC) is an important disease with the incidence of 6th all over the world. In Taiwan it is the fifth of male cancer mortality. Most of the patients were middle age and the impact for economy and society was incredible. For recurrent or metastatic HNSCC, the average life span was around 4-6 months. Most patients just can receive chemotherapy. However the chemotherapy can't have any survival benefit. Recently a study showed the Cetuximab plus chemotherapy with cisplatin and 5-fluorouracil had survival benefit in the recurrent or metastatic HNSCC. However in Taiwan, the cetuximab can't be given by health insurance for the patients of the situation.

A lot of investigations recently showed the B lymphocytes got involvements in the squamous cell carcinoma carcinogenesis and tumor progression. In addition the B cell will influence the tumor associated macrophages and myeloid derived suppressor cells. Those immune cells could decrease the affect of chemotherapy and radiotherapy. Thus the B cell depletion has the possibility to develop a new treatment policy. Therefore investigators create a pilot clinical trial using Rituximab plus chemotherapy with cisplatin and gemcitabine for recurrent or metastatic HNSCC.

Keywords
head and neck squamous cell carcinoma, Rituximab, recurrent or metastatic
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Mab thera

    375mg/m2 on Day-14 and Day-7

  • CisplatinDrug

    Also called Platinex

    70mg/m2 on Day1

  • GemcitabineDrug

    Also called Gemzar

    1000mg/m2 on Day8

Study groups in NCT04361409
Study groupRoleWhat they receive
Rituximab plus chemotherapyExperimental* Drug:Rituximab * Drug:Cisplatin * Drug:Gemcitabine
Receives: Drug: Rituximab; Drug: Cisplatin; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. feasibility of the combination of Rituximab with Gemcitabin/cisplatin in R/M HNSCC

    Unexpected adverse event. An AE that is not listed in the drug's current labeling, or An AE that is more severe or more specific than indicated in the labeling.

    Measured: One week after Rituximab and chemotherapy administration.

Secondary outcomes (3)

  1. Response rate

    CT scan according to the RECIST 1.1 criteria.

    Measured: through study completion, an average of 1 years

  2. progression survival

    The time from the study registration date to the first day of disease progression at any site or of death by any cause.

    Measured: through study completion, an average of 6 months

  3. Adverse event

    Record adverse event

    Measured: through study completion, an average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study startMay 2013
  3. Primary completionNov 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04361409
Sponsor's protocol ID
CMUH HO-02
Status last verified
Apr 2020
First submitted
21 Aug 2013
Last updated
28 Apr 2020
Results posted
No
Data monitoring committee
No

Publications

  • Hsieh CY, Lien MY, Lin CY, Lo WJ, Hua CH, Chang WC, Chiu CF, Lin CC. Rituximab in combination with gemcitabine plus cisplatin in patients with recurrent and metastatic head and neck squamous cell carcinoma: a phase I trial. BMC Cancer. 2022 Feb 15;22(1):169. doi: 10.1186/s12885-022-09258-0.

    PubMed 35168547

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Rituximab, Cisplatin and Gemcitabine in people with Head and Neck Squamous Carcinoma, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

feasibility of the combination of Rituximab with Gemcitabin/cisplatin in R/M HNSCC (time frame: One week after Rituximab and chemotherapy administration.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04361409, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2020.

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