Status:
COMPLETED
DNA Repair Inhibitor & Irradiation on Melanoma
Lead Sponsor:
DNA Therapeutics
Conditions:
Local Metastatic Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 Th...
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 th...
Eligibility Criteria
Inclusion
- 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:
- 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examinations to any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
Exclusion
- 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;
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT01469455
Start Date
October 1 2011
End Date
July 1 2015
Last Update
June 17 2016
Active Locations (12)
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1
Hôpital Saint-André
Bordeaux, France, 33075
2
Hôpital Ambroise Paré
Boulogne-Billancourt, France, 92104
3
Centre Oscar Lambret
Lille, France, 59020
4
Hôpital de la Timone
Marseille, France, 13385