Local Metastatic MelanomaPhase 1DRIIMNCT01469455
DNA Repair Inhibitor & Irradiation on Melanoma
A Phase 1 study testing DT01 in people with Local Metastatic Melanoma, run by DNA Therapeutics at 12 sites in France.
Trial summary
Phase I trial will be conducted in patients suffering local metastatic melanoma with relapsed cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the preclinical data package, DNA Therapeutics has considered that the risk-benefit ratio of DT01 supports the initiation of a phase I clinical study in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Local Metastatic Melanoma
- What is being tested?
- DT01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 12 sitesFrance
- Study dates
- Oct 2011to Jul 2015
- 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
- Patients with histologically confirmed metastatic melanoma with relapsed cutaneous tumors, including melanoma-in-transit, who are not eligible for immediate surgery or refractory to conventional treatment;
- Patients with at least two measurable tumors of ≤ 4cm in largest diameter. Treated tumors must not be previously irradiated.
- The consideration of tumor size and number for the 5th and expansion cohorts can be revised based on the observation for the 4 first cohorts, in particular the initial indication of efficacy, after an agreement between Principal Investigators, the DSMB and the Sponsor.
- Normal haematopoietic function as assessed by a complete blood count including differential count.
- i.Absolute neutrophil count ≥ 1.5 x 109/L; ii.Platelet count ≥ 100 x 109/L; iii.Haemoglobin ≥ 10 g/dL (transfusions are permitted);
- No clinically relevant abnormalities in the results of the pre-study laboratory tests:
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- i.Creatinine ≤ 1.5 times UNL (upper normal of the limit) ; ii.Bilirubin ≤ 1.5 times UNL; iii.ASAT (SGOT) ≤ 2.5 times the upper limit of normal if no liver metastasis and ≤ 5 times the upper limit of normal in the presence of liver metastasis ; iv.ALAT (SGPT) ≤ 2.5 times the upper limit of normal if no liver metastasis and ≤ 5 times the upper limit of normal in the presence of liver metastasis;
- Age ≥18 years old;
- The patient is willing and able to comply with the protocol for the duration of the study, including 1 day of hospitalization for PK sample at Day 1 and scheduled follow-up visits and examinations to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Who cannot join
- Presence of any serious concomitant systemic disorders incompatible with the study (e.g. active infection);
- Known or suspected Central Nervous System (CNS) metastases including leptomeningeal metastases (unless the patient has been previously treated and the patient meets the three following criteria: is asymptomatic, has no evidence of active CNS metastases for more than 3 months prior to enrollment, and has no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days);
- Patients with a history of porphyria;
- Patients with active psoriasis;
- Clinically significant hepatic disease (particularly cirrhosis) or renal disease;
- Severe gastrointestinal, neurological and blood disorders;
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- Patients receiving anti-vitamin K therapy within 10 days prior to first dose of study treatment (Low Molecular Weight Heparin (LMWH) therapy is allowed);
- Anticancer therapy (chemotherapy, hormone therapy or immunotherapy) within 4 weeks prior to first dose of study treatment and immunotherapy with Ipilimumab, within 3 months prior to first dose of study treatment ;
- Patients receiving cyclosporin within 10 days prior to first dose of study treatment;
- Patients intended to receive any systemic anticancer therapy within 26 days (±2 days) from the anticipated date of the first administration of DT01
- Pregnant or breast-feeding women, or women of child-bearing potential unless effective methods of contraception are used. Child-bearing potential is defined as:
- i.Has experienced menarche, and ii.Has not undergone successful surgical sterilisation, and iii.Is not post-menopausal (amenorrhea > 12 consecutive months or is on Hormone Replacement Therapy (HRT) with a documented plasma or serum FSH > 35 IU/L. iv.Women using oral, implanted, injectable, mechanical or barrier products for the prevention of pregnancy, or who are practising abstinence, or where the partner is sterile (for example, a vasectomy) should be considered to be of child-bearing potential
- Concomitant participation to another study;
- Hypersensitivity to 4-aminoquinoline compounds (chloroquine) or to any of its derivatives;
- HIV and Hepatitis B or C positive patients;
- Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2
- Retinal or visual field changes attributable to previous chloroquine administration or any other etiology;
- Any reason why, in the Investigator's opinion, the patient should not participate in the study.
- Disease burden judged high, and therefore the patient can not likely benefit from the proposed treatment.
- Significant coagulation abnormalities
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Hôpital Saint-André
Bordeaux, 33075
Hôpital Ambroise Paré
Boulogne-Billancourt, 92104
Centre Oscar Lambret
Lille, 59020
Hôpital de la Timone
Marseille, 13385
Hôpital hôtel-Dieu
Nantes, 44093
CHU de Nice - Archet 2
Nice, 06202
Groupe Hospitalier Cochin - Hôtel Dieu-Broca
Paris, 75006
Institut Curie
Paris, 75248
Hôpital Saint-Louis
Paris, 75475
APHP Hôpital Bichat - Claude Bernard
Paris, 75877
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Hôpital Charles Nicolle
Rouen, 76031
About this study
Official title: An Open Label, Non-randomized, First-in-human, Multi-centre Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Locally Administered DT01 in Combination With Radiotherapy and Concomitant Dose of Chloroquine in Patients With Local Metastatic Melanoma With Relapsed Cutaneous/Subcutaneous Tumors Including Melanoma-in-transit
Phase I trial will be conducted in patients suffering local metastatic melanoma with relapsed cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the preclinical data package, DNA Therapeutics has considered that the risk-benefit ratio of DT01 supports the initiation of a phase I clinical study in this population. The recommended starting dose of DT01 for the first injection to human was based on NOAELs and Maximum Recommended Starting Dose (MRSD) calculations and by considering both local and systemic approaches. It was set at 16 mg (4 mg per injection site, 2 injections per tumor, 2 tumors to be treated). This starting dose will be increased up to 96 mg if no DLT occurred during dose escalation.
DT01 will be locally administered by peritumoral subcutaneous and/or intratumoral injections in combination with hypo-fractionated radiotherapy (RT) (10x 3 Gy) and chloroquine (100 mg oral QD) starting one week before DT01 and RT treatments. DT01 will be administered 3 times a week during two weeks; The study will be an open, non-randomised, multicentre, phase I dose escalation (16, 32, 48, 64 and 96 mg) safety study with a 3+3 design.
The purpose of this study will be to evaluate the safety, tolerance, pharmacokinetics of DT01 in association with palliative radiotherapy and to evaluate pharmacodynamics and the anti-tumor activity of DT01 according to RECIST criteria on day 26, 40 and 54. The duration of response (Time-To-Local Recurrence, TTLR), will be monitored 3, 6, 9 and 12 months after the beginning of the DT01 treatment.
Read the detailed description
According to the WHO, the incidence of melanoma is 199,627 worldwide in 2008, of which the melanoma-in-transit is about 4%. When melanoma spreads, it does so by the lymphatic system which drains to the regional lymph nodes. Uncommonly, melanoma can become trapped in the lymphatic vessels and grow to cause tumor nodules in the skin and subcutaneous tissues between the primary site and the regional lymph node basin. These nodules are termed in-transit metastases and carry an ominous prognosis. The American Joint Committee on Cancer (AJCC) defines such in-transit metastases as any skin or subcutaneous metastases that are more than 2 cm from the primary lesion but are not beyond the regional nodal basin. The 2010 tumor node metastasis (TNM) staging system considers the melanoma-in-transit a N2c stage when they arise in the absence of nodal metastases.
The current treatment options (approved or in late stage development) are:
- Local excision, if there are only a few;
- Isolated limb perfusion (local high dose chemotherapy);
- Systemic chemotherapy (Dacarbazine, Temozolomide, Cis-platine);
- Targeted therapy (B-raf inhibitors: Vemurafenib and Dabrafenib; MEK inhibitor: Trametinib);
- Immunotherapy (Ipilimumab, Nivolumab, Pembrolizumab, OncoVEX GM-CSF, Tumor Infiltrating Lymphocytes and interleukin-2 [IL-2]);
- Radiotherapy;
- Photodynamic therapy;
- Laser vaporization. With rare exceptions, none of these treatments are curative. Immunotherapy results in prolongation of survival although overall response rate remains low (ref: oncovex phase II study).
According to the Sponsor's clinical development strategy and plan, the local metastatic melanoma with relapsed cutaneous/subcutaneous tumors, including melanoma-in-transit, has been chosen as the 1st indication for evaluating safety, tolerance and PK of DT01 in combination with a palliative radiotherapy (10x3 Gy). The presence of multiple cutaneous/subcutaneous tumor should provide an initial clinical evaluation of the safety and skin tolerance of the combined treatment of DT01 and 10x3 Gy irradiation, as well as a preliminary assessment of anti-tumor activity (proof of concept) of DT01 to sensitize and improve the response rate of radiotherapy (estimated about 50% response rate), and to delay local relapse.
Based on the pharmacologically active dose in human melanoma xenografted tumor in mice and the wide safety margin estimated from the toxicology data, the starting dose of 16 mg and the planned dose escalation represent a conservative approach for titration. The dose escalation will provide valuable information about the safety, tolerance and preliminary efficacy data.
- Conditions
- Local Metastatic Melanoma
- Being tested
- DT01
- Keywords
- Local metastatic melanoma, relapsed cutaneous/subcutaneous tumors, melanoma-in-transit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DT01Drug
DT01 starting dose will be 16 mg and it is planned to be increased to 32, 48 mg and 64 mg, or higher.
DT01 will be administered 3 times a week (e.g., Mondays, Wednesdays and Fridays) over 2 weeks (6 administrations of DT01 in total) at least 3 hours prior to the radiotherapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| DT01 | Experimental | Not described Receives: Drug: DT01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability and safety analysis, according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (NCI-CTCAE v4.0) criteria.
Tolerability and safety analysis, according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (NCI-CTCAE v4.0) criteria.
Measured: over a period of 54 days
Secondary outcomes (1)
Profile of pharmacokinetics(PK)
- Cmax The plasma peak concentration
- tmax The time to reach the peak concentration
- AUCt The area under the concentration-time curve from time zero to the last sample with the quantifiable concentration
- AUC∞ The area under the concentration-time curve from time zero to infinity
- t½ The terminal elimination half-life
Measured: pre-dose,1, 2.5, 4.5, 6.5, 9,24h post dose on Day 1, and pre-dose,4.5h post dose on Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Metastatic MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- DNA Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe LE TOURNEAU, MD, Principal investigator, Institut Curie - National CoordinatorMarie-Françoise AVRIL, MD, Principal investigator, Groupe Hospitalier Cochin - Hôtel Dieu-BrocaPhilippe SAIAG, MD, Principal investigator, Hospital Ambroise Paré ParisCéleste LEBBE, MD, Principal investigator, Hôpital Saint-LouisJean-Jacques GROB, MD, Principal investigator, Hôpital de la TimoneBrigitte DRENO, MD, Principal investigator, Hôpital hôtel-DieuCaroline DUTRIAUX, MD, Principal investigator, Hôpital Saint-AndréLaurent MORTIER, MD, Principal investigator, Hôpital Claude-Huriez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01469455
- Sponsor's protocol ID
- DT01-01
- Acronym
- DRIIM
- Status last verified
- Jun 2016
- First submitted
- 24 Oct 2011
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non-randomized, First-in-human, Multi-centre Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Locally Administered DT01 in Combination With Radiotherapy and Concomitant Dose of Chloroquine in Patients With Local Metastatic Melanoma With Relapsed Cutaneous/Subcutaneous Tumors Including Melanoma-in-transit
- ClinicalTrials.gov ID
- NCT01469455
- Acronym / sponsor ID
- DRIIM / DT01-01
- Conditions
- Local Metastatic Melanoma
- Keywords
- Local metastatic melanoma, relapsed cutaneous/subcutaneous tumors, melanoma-in-transit
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- DNA TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I trial will be conducted in patients suffering local metastatic melanoma with relapsed cutaneous/subcutaneous tumors including melanoma-in-transit. Based on the preclinical data package, DNA Therapeutics has considered that the risk-benefit ratio of DT01 supports the initiation of a phase I clinical study in this population. The recommended starting dose of DT01 for the first injection to human was based on NOAELs and Maximum Recommended Starting Dose (MRSD) calculations and by considering both local and systemic approaches. It was set at 16 mg (4 mg per injection site, 2 injections per tumor, 2 tumors to be treated). This starting dose will be increased up to 96 mg if no DLT occurred during dose escalation.
DT01 will be locally administered by peritumoral subcutaneous and/or intratumoral injections in combination with hypo-fractionated radiotherapy (RT) (10x 3 Gy) and chloroquine (100 mg oral QD) starting one week before DT01 and RT treatments. DT01 will be administered 3 times a week during two weeks; The study will be an open, non-randomised, multicentre, phase I dose escalation (16, 32, 48, 64 and 96 mg) safety study with a 3+3 design.
The purpose of this study will be to evaluate the safety, tolerance, pharmacokinetics of DT01 in association with palliative radiotherapy and to evaluate pharmacodynamics and the anti-tumor activity of DT01 according to RECIST criteria on day 26, 40 and 54. The duration of response (Time-To-Local Recurrence, TTLR), will be monitored 3, 6, 9 and 12 months after the beginning of the DT01 treatment.
Detailed description
According to the WHO, the incidence of melanoma is 199,627 worldwide in 2008, of which the melanoma-in-transit is about 4%. When melanoma spreads, it does so by the lymphatic system which drains to the regional lymph nodes. Uncommonly, melanoma can become trapped in the lymphatic vessels and grow to cause tumor nodules in the skin and subcutaneous tissues between the primary site and the regional lymph node basin. These nodules are termed in-transit metastases and carry an ominous prognosis. The American Joint Committee on Cancer (AJCC) defines such in-transit metastases as any skin or subcutaneous metastases that are more than 2 cm from the primary lesion but are not beyond the regional nodal basin. The 2010 tumor node metastasis (TNM) staging system considers the melanoma-in-transit a N2c stage when they arise in the absence of nodal metastases.
The current treatment options (approved or in late stage development) are:
- Local excision, if there are only a few;
- Isolated limb perfusion (local high dose chemotherapy);
- Systemic chemotherapy (Dacarbazine, Temozolomide, Cis-platine);
- Targeted therapy (B-raf inhibitors: Vemurafenib and Dabrafenib; MEK inhibitor: Trametinib);
- Immunotherapy (Ipilimumab, Nivolumab, Pembrolizumab, OncoVEX GM-CSF, Tumor Infiltrating Lymphocytes and interleukin-2 [IL-2]);
- Radiotherapy;
- Photodynamic therapy;
- Laser vaporization. With rare exceptions, none of these treatments are curative. Immunotherapy results in prolongation of survival although overall response rate remains low (ref: oncovex phase II study).
According to the Sponsor's clinical development strategy and plan, the local metastatic melanoma with relapsed cutaneous/subcutaneous tumors, including melanoma-in-transit, has been chosen as the 1st indication for evaluating safety, tolerance and PK of DT01 in combination with a palliative radiotherapy (10x3 Gy). The presence of multiple cutaneous/subcutaneous tumor should provide an initial clinical evaluation of the safety and skin tolerance of the combined treatment of DT01 and 10x3 Gy irradiation, as well as a preliminary assessment of anti-tumor activity (proof of concept) of DT01 to sensitize and improve the response rate of radiotherapy (estimated about 50% response rate), and to delay local relapse.
Based on the pharmacologically active dose in human melanoma xenografted tumor in mice and the wide safety margin estimated from the toxicology data, the starting dose of 16 mg and the planned dose escalation represent a conservative approach for titration. The dose escalation will provide valuable information about the safety, tolerance and preliminary efficacy data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DT01 | Experimental | Drug: DT01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with histologically confirmed metastatic melanoma with relapsed cutaneous tumors, including melanoma-in-transit, who are not eligible for immediate surgery or refractory to conventional treatment;
- Patients with at least two measurable tumors of ≤ 4cm in largest diameter. Treated tumors must not be previously irradiated.
- The consideration of tumor size and number for the 5th and expansion cohorts can be revised based on the observation for the 4 first cohorts, in particular the initial indication of efficacy, after an agreement between Principal Investigators, the DSMB and the Sponsor.
- Normal haematopoietic function as assessed by a complete blood count including differential count.
- i.Absolute neutrophil count ≥ 1.5 x 109/L; ii.Platelet count ≥ 100 x 109/L; iii.Haemoglobin ≥ 10 g/dL (transfusions are permitted);
Key exclusion criteria (20 listed)
- Presence of any serious concomitant systemic disorders incompatible with the study (e.g. active infection);
- Known or suspected Central Nervous System (CNS) metastases including leptomeningeal metastases (unless the patient has been previously treated and the patient meets the three following criteria: is asymptomatic, has no evidence of active CNS metastases for more than 3 months prior to enrollment, and has no requirement for steroids or enzyme-inducing anticonvulsants in the last 14 days);
- Patients with a history of porphyria;
- Patients with active psoriasis;
- Clinically significant hepatic disease (particularly cirrhosis) or renal disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DT01DT01 starting dose will be 16 mg and it is planned to be increased to 32, 48 mg and 64 mg, or higher. DT01 will be administered 3 times a week (e.g., Mondays, Wednesdays and Fridays) over 2 weeks (6 administrations of DT01 in total) at least 3 hours prior to the radiotherapy sessions. | Drug | DT01 |
Primary outcome
Tolerability and safety analysis, according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (NCI-CTCAE v4.0) criteria.
Time frame: over a period of 54 days
Tolerability and safety analysis, according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (NCI-CTCAE v4.0) criteria.
1 secondary outcome
Profile of pharmacokinetics(PK)
Time frame: pre-dose,1, 2.5, 4.5, 6.5, 9,24h post dose on Day 1, and pre-dose,4.5h post dose on Day 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
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Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe LE TOURNEAU, MD principal investigator
Institut Curie - National Coordinator
Marie-Françoise AVRIL, MD principal investigator
Groupe Hospitalier Cochin - Hôtel Dieu-Broca
Philippe SAIAG, MD principal investigator
Hospital Ambroise Paré Paris
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DT01 in people with Local Metastatic Melanoma, run by DNA Therapeutics at 12 sites in France.
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 20 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 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France. 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?
Tolerability and safety analysis, according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4 (NCI-CTCAE v4.0) criteria. (time frame: over a period of 54 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jun 2016.