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MelanomaPhase 1NCT00815607

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

A Phase 1 study testing INXN-1001 and INXN-3001 in people with Melanoma, run by Alaunos Therapeutics at 8 sites in United States.

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

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Melanoma
What is being tested?
INXN-1001 and INXN-3001
How many people
12 participants
Where
8 sitesUnited States
Study dates
Apr 2009to Jan 2013
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • A Body Mass Index (BMI) greater than or equal to 40 kg/m2; aa. Patients who have a history of hypersensitivity that may relate to any component of the product, e.g. to benzoic acid that might be related to INXN-1001, which contains two benzene rings; bb. Any medical or psychiatric condition which, in the opinion of the investigator, would unacceptably reduce the safety or delivery of the proposed treatment, or would preclude obtaining voluntary informed consent.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Billings Clinic

    Billings, Montana, 59101

  • Mary Crowley Cancer Research Centers

    Dallas, Texas, 75201

  • Goshen Clinic

    Goshen, Indiana, 46526

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Helen F. Graham Cancer Center

    Newark, Delaware, 19713

  • Oncology Specialists, S.C.

    Park Ridge, Illinois, 60068

  • The Angeles Clinic and Research Institute

    Santa Monica, California, 90404

  • • Nancy N. and J.C. Lewis Cancer Center & Research Pavilion at St. Joseph/Candles

    Savannah, Georgia, 31405

Other trials in United States

About this study

Official title: Phase 1b' Open Label, Single Arm, Multicenter Trial to Evaluate the Safety, Tolerance, Response Rate and Immunological Effects of Repeated Intratumoral Injections of Adenoviral Transduced Autologous Dendritic Cells Engineered to Express hIL-12(INXN-3001) in Response to an Oral Activator Ligand in Patients With Unresectable Stage III C or IV Malignant Melanoma

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

Read the detailed description

This study will examine the effects of an oral Activator Ligand administration to modulate the timing of gene expression of human IL-12 by adenovirus-transduced dendritic cells injected into tumors.

Conditions
Melanoma
Being tested
INXN-1001, INXN-3001
Keywords
melanoma, biologic, immunotherapy, cancer
Medical subject headings
Melanoma, Neoplasms

What participants receive

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

  • INXN-1001Drug

    Capsules given once daily for 14 days for 3 treatment cycles.

  • INXN-3001Biological

    Intratumoral injection

What is being measured

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

  1. Physical examinations, vital signs, serum chemistry, urinalysis, hematology, adverse events, and objective response rate, as assessed by diagnostic CT scans

    Measured: throughout the study

Secondary outcomes (1)

  1. PK of oral Activator Ligand, Immunologic responses, particularly frequency of CTLs and Tregs and hIL-12 and other cytokine levels in injected target tumor(s) and in peripheral blood, Efficacy.

    Measured: throughout the study

Timeline

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

  1. First posted30 Dec 2008 (estimated)
  2. Study startApr 2009
  3. Primary completionJan 2013
  4. Study completionJan 2013

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00815607
Sponsor's protocol ID
RTS-M101B'
Other IDs
NIH OBA 0710-881
Status last verified
Jul 2013
First submitted
19 Dec 2008
Last updated
18 Jul 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing INXN-1001 and INXN-3001 in people with Melanoma, run by Alaunos Therapeutics at 8 sites in United States.

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 10 inclusion and 26 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 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. 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?

Physical examinations, vital signs, serum chemistry, urinalysis, hematology, adverse events, and objective response rate, as assessed by diagnostic CT scans (time frame: throughout the study). 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 NCT00815607.

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 18 Jul 2013.

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