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Head and Neck CancerPhase 1DERANONCT04252248

Decitabine Treatment in HPV-Induced Anogenital and Head and Neck Cancer Patients After Radiotherapy or as Novel Late Salvage

A Phase 1 study testing Dacogen in people with Head and Neck Cancer and Anogenital Cancer, run by University Hospital Heidelberg at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Open-label, single-center phase I study to evaluate first signs of efficacy and to confirm the safety and tolerability of a decitabine safe-dose treatment in two strata of patients with HPV induced anogenital and head and neck cancers (Stratum 1: patients with high rist for disease recurrence; Stratum 2: patients with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer, Anogenital Cancer
What is being tested?
Dacogen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteGermany
Study dates
11 Oct 2019to 15 Jun 2021
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Patients meeting all of the following criteria will be considered for admission to the trial: Patients with an HPV-induced (will be assumed if both HPV DNA and immunohistochemical overexpression of p16INK4a is detected in tumor tissue) cancer of the
  • anus
  • vulva
  • vagina
  • uterine
  • cervix
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  • penis or
  • oropharynx/oral cavity and
  • Stratum 1: Patients having received standard, definitive chemoradiotherapy according to current national guidelines with curative intent and being at high risk for disease recurrence (patients are considered at high risk if they display a positive nodal status of their cancer (anogenital HPV-induced tumor) or if the tumor is locally advanced and/or if they display a positive nodal status with extracapsular extension (head and neck HPV-induced tumor). Study therapy (as additional therapy to standard chemoradiation) will start after a time interval of 6-8 weeks after finishing chemoradiotherapy.
  • Stratum 2: Patients with non-curative and progressive disease having received all standard, national approved systemic therapies (according to current, national guidelines with regard to the specific tumor entity), and/or presently not eligible for a respective therapy, and/or refused respective therapy. Study treatment thereby represents a potential palliative, "last-line" systemic therapy option (late salvage).
  • Ability of patient to understand character and individual consequences of the clinical trial
  • Postmenopausal or evidence of non-childbearing status. For women of childbearing potential: negative urine pregnancy test at baseline and highly effective forms of contraception (see 6.5) in place thereafter as well as confirmed negative urine pregnancy test prior to treatment on day 1 of every cycle and at end of treatment period Evidence of childbearing potential is defined as:
  • Fertile, following menarche and until becoming post-menopausal unless permanently sterile Postmenopausal or evidence of non-childbearing status is defined as: o Amenorrheic for 1 year or more without an alternative medical cause following cessation of exogenous hormonal treatments PLUS Follicle stimulating hormone (FSH) levels in the postmenopausal range in women not using hormonal contraception or hormonal replacement therapy
  • Surgical sterilisation (bilateral oophorectomy, hysterectomy or bilateral salpingectomy) A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
  • Female patients of child bearing potential and male patients with partners of child bearing potential, who are sexually active, must agree to the use of highly effective forms of contraception. This should be started from the signing of the informed consent and continue throughout period of taking study treatment and for 6 months (female study participants)/ 3 months (male study participants) after last dose of study drug.
  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study (must be given before enrolment in the trial)
  • Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Who cannot join

  • Patients presenting with any of the following criteria will not be included in the trial:
  • Age <18 years
  • Grade 3 neutropenia with Neutrophiles < 1/nl, thrombocytopenia with thrombocytes < 50/nl and/ or anemia with Hgb <8.0 g/dL
  • Active infections requiring anti-infective treatment
  • Bleeding disorders (e.g. Hemophilia, von Willebrandt disease, congestive deficiency of any coagulation factor (e.g. factor V, X), Immune thrombocytopenia (ITP) thrombocytopathies (e.g. Bernard-Soulier-syndrome drug induced bleeding disorders
  • Insulin-dependent and unregulated diabetes
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  • Grade 3/4 renal failure with a GFR < 60 ml/min
  • Liver cirrhosis Child C • History of cardiac diseases
  • Pregnancy and/ or lactation • History of treatment with DNA Methyltransferase Inhibitors (DNMTs)
  • Participation in other clinical trials involving another investigational agent within 4 weeks prior to first treatment of this study
  • ECOG performance status >2
  • History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
  • History of other malignancies (except basal cell carcinoma) in the past 5 years No patient will be allowed to enroll in this trial more than once.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • UKHD, Klinik für RadioOnkologie und Strahlentherapie

    Heidelberg, 69120

Other trials in Germany

About this study

Official title: Decitabine Treatment in HPV-Induced Anogenital and Head and Neck Cancer Patients After Radiotherapy or as Novel Late Salvage (DERANO)

Open-label, single-center phase I study to evaluate first signs of efficacy and to confirm the safety and tolerability of a decitabine safe-dose treatment in two strata of patients with HPV induced anogenital and head and neck cancers (Stratum 1: patients with high rist for disease recurrence; Stratum 2: patients with failure of standard therapy). The study is expected to enroll 18 patients overall (9 patients in each stratum).

The duration of the trial for each patient is expected to be 6 months (two 28 day cycles of study treatment plus four months of additional follow-up). The overall duration of the trial is expected to be approximately 42 months.

Being tested
Dacogen
Medical subject headings
Head and Neck Neoplasms

What participants receive

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

  • DacogenDrug

    Intravenous (i.v.) infusion of 20 mg/m2 over 1 hour repeated daily for 5 days starting on day 1. Single repetition of cycle on day 29.

Study groups in NCT04252248
Study groupRoleWhat they receive
Stratum 1ExperimentalPatients having received standard, definitive chemoradiotherapy according to current, national guidelines with curative intent and being at high risk for disease recurrence (patients are considered at high risk if they display a positive nodal status of their cancer (anogenital HPV-induced tumor) or if the tumor is locally advanced and/or if they display a positive nodal status with extracapsular extension (head and neck HPV-induced tumor). Study therapy (as additional therapy to standard chemoradiation) will start after a time interval of 6-8 weeks after finishing chemoradiotherapy
Receives: Drug: Dacogen
Stratum 2ExperimentalPatients with non-curative and progressive disease having received all standard, national approved systemic therapies (according to current, national guidelines with regard to the specific tumor entity), and/or presently not eligible for a respective therapy, and/or refused respective therapy. Study treatment thereby represents a potential palliative, "last-line" systemic therapy option (late salvage).
Receives: Drug: Dacogen

What is being measured

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

  1. Incidence of dose limiting toxicities (DLT)

    The primary objective of the study is to evaluate the safety and tolerability of decitabine treatment in two strata of patients with HPV-induced anogenital and head and neck cancer. Primary endpoint is the incidence of dose limiting toxicities (DLT) during the first two cycles of study treatment (up to day 56). DLT will be assessed and managed independently for both strata.

    Measured: 56 days

Secondary outcomes (7)

  1. Overall Response Rate

    The Overall Response Rate (or Objective Response Rate) is defined as the proportion of patients achieving a complete (CR) or partial (PR) response in their overall response assessment according to RECIST v1.1 measured at the 6 months staging vs baseline.

    Measured: 6 months

  2. Disease Control Rate (DCR)

    The Disease Control Rate (DCR) is defined as the proportion of patients achieving stable disease or a better outcome (CR, PR, SD) in their overall response assessment according to RECIST v1.1 measured at the 6 months staging vs baseline.

    Measured: 6 months

  3. Quality of Life

    Quality-of-Life (QoL) will be assessed by the EORTC Quality of Life Core Questionnaire (QLQ30), supplemented by information on self-assessed concomitant diseases and demographics. QoL will be assessed at baseline, and at week 3, 5, 8 and 24 (EOS)

    Measured: week 3, 5, 8 and 24

  4. Overall Survival (OS)

    OS is defined as the time from admission to the study until death from any cause. Patients who are alive at the end of the study are censored on the day of last contact.

    Measured: from admission until Last Patient Last Visit (LPLV), assessed ≥ 6 months

  5. Progression-free Survival (PFS)

    PFS is defined as the time from admission to the study until progression of disease or death from any cause, whichever occurs first. Patients who are alive and did not have progression of disease at the end of the study are censored on the day of last contact.

    Measured: from admission until Last Patient Last Visit (LPLV), assessed ≥ 6 months

  6. Overall Response Rate

    The ORR-3m is defined as the proportion of patients achieving a complete (CR) or partial (PR) response in their overall response assessment according to RECIST v1.1 measured at the 3 months staging vs baseline.

    Measured: 3 months

  7. Disease Control Rate

    The DCR-3m is defined as the proportion of patients achieving stable disease or a better outcome (CR, PR, SD) in their overall response assessment according to RECIST v1.1 measured at the 3 months staging vs baseline.

    Measured: 3 months

Timeline

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

  1. First posted5 Feb 2020
  2. Study start11 Oct 2019
  3. Primary completion15 Jun 2021
  4. Study completion15 Jun 2021

Why it stopped: Organizational reasons

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04252248
Sponsor's protocol ID
NCT-2014-0250
Acronym
DERANO
Status last verified
Sep 2021
First submitted
28 Jan 2020
Last updated
6 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dacogen in people with Head and Neck Cancer and Anogenital Cancer, run by University Hospital Heidelberg at 1 site in Germany.

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 17 inclusion and 13 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: stopped early, as of the sponsor's last update on 6 Oct 2021. 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 Germany. 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 was stopped early (reason given: Organizational reasons). Results are not available in the source record.

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?

Incidence of dose limiting toxicities (DLT) (time frame: 56 days). 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 NCT04252248.

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 6 Oct 2021.

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