Trial of an Intratumoral Injections of INXN-3001 in Subjects With Stage III or IV Melanoma

Completed · Phase 1

Conditions studied: Melanoma

In brief

The purpose of this study is to test the safety of an investigational combination drug/immunotherapy for the treatment of Stage III/IV melanoma.

Key facts

Study ID

NCT00815607

Run by

Alaunos Therapeutics

People needed

12

Starts

2009-04-01

Expected to finish

2013-01-01

Last updated by the study team

2013-07-18

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females of all races ≥ 18 years of age and ≤ 75 years of age;
• Unresectable Stage III C (in transit) or Stage IV melanoma (M1a, M1b, M1c with LDH ≤ 2x ULN), arising from primary cutaneous, mucosal, or subungual melanoma of any tumor thickness or from an unknown primary site;
• A minimum of 2-3 accessible nonvisceral lesions (longest diameter ≤3 cm) or palpable tumor-involved lymph nodes (longest diameter ≤5 cm) for intratumoral injections (INXN-3001) and biopsies;
• ECOG performance status of 0 or 1;
• Patients without visible brain metastases as assessed by contrast-enhanced MRI scan within 6 weeks prior to receiving study treatment;
• Adequate baseline hematological and organ function, assessed by laboratory values within 42 days (6 weeks) prior to study entry and prior to repeat treatment cycles with INXN-1001 as follows: hemoglobin ≥ 10 g/L, granulocytes > 2500/mm3, lymphocytes > 1000/ mm3, platelets > 100,000/ mm3, serum creatinine < 1.5 x ULN, AST, ALT, alkaline phosphatase < 2.5 x ULN, LDH ≤ 2 x ULN, serum bilirubin < 1.5 x ULN, absolute neutrophils > 500/ mm3;
• An expected survival of at least approximately 6 months in the opinion of the investigator (as assessed mainly by performance status);
• Females must be post-menopausal or surgically sterile or practice effective contraception; Men who are not surgically sterile and whose partners are not post-menopausal or surgically sterile must practice effective contraception;
• Normal coagulation parameters as measured by PT/PTT;
• Signed, IRB-approved voluntary written informed consent.

You may not qualify if…

• Active, acute viral, bacterial, or fungal infections requiring specific therapy;
• HIV-infection due to concerns about ability to mount an effective immune response;
• Active autoimmune disease requiring steroids (>10 mg prednisolone or comparable) or other immunosuppressive therapy;
• Patients with detectable brain metastases at the time of screening (or within 6 weeks prior to receiving study treatment), as assessed by contrast-enhanced MRI scans;
• Patients with one or more lesion(s) > 3cm (LD) or palpable, tumor-involved lymph node(s) >5 cm (LD);
• Patients with a hemoglobin of < 10 g/L;
• Presence of Stage IV visceral metastases or other distant metastases if LDH >2 x ULN;
• Patients who have previously been treated with INXN-3001 and INXN-1001;
• Recipients of organ allografts;
• Other concurrent, clinically active malignant disease, with the exception of other cancers of the skin;
• Less than 30 days (before the first dose of study medication) have elapsed since the completion of prior chemotherapy, hormonal therapy, radiotherapy, immunotherapy, or any first line therapy;
• Clinically significant cerebrovascular disease;
• History of or concurrent severe cardiac insufficiency (New York Heart Association Class III or IV) or coronary artery disease;
• QTc interval of >470 ms on screening;
• Inability to measure the QT interval due to conduction abnormalities such as Bundle Branch Block (left or right) or persistent cardiac arrhythmia e.g. atrial fibrillation, or cardiac pacemaker;
• Long QT syndrome or family history of sudden cardiac death in young family members;
• Concomitant use of medication known to affect ventricular repolarization;
• Cardiac comorbidity such as a left ventricular ejection fraction <45%, myocardial infarction, persistent angina, or cardiac surgery within 3 months prior to enrollment;
• Uncontrollable hypertension (>150 mm Hg systolic or >100 mm Hg diastolic);
• Acute medical conditions such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk;
• History of or current bleeding or uncorrected clotting disorders;
• Concurrent immunosuppressive therapy such as corticosteroids (>10mg prednisolone or comparable) and cyclosporin A;
• Concurrent investigational treatments, or treatment with any investigational treatment within the past 30 days (prior to the first dose of study medication);
• Concurrent medications that are metabolized by the CYP 3A4 pathway;
• Females who are lactating or pregnant;

Where it is running

• The Angeles Clinic and Research Institute — Santa Monica, California, United States
• Helen F. Graham Cancer Center — Newark, Delaware, United States
• • Nancy N. and J.C. Lewis Cancer Center & Research Pavilion at St. Joseph/Candles — Savannah, Georgia, United States
• Oncology Specialists, S.C. — Park Ridge, Illinois, United States
• Goshen Clinic — Goshen, Indiana, United States
• Billings Clinic — Billings, Montana, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Mary Crowley Cancer Research Centers — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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