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Non Small Cell Lung CancerPhase 1NCT01124812

131I-L19SIP Radioimmunotherapy Combined With Radiochemotherapy in Patients With Locally-advanced Non Small Cell Lung Cancer (NSCLC)

A Phase 1 study testing 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy in people with Non Small Cell Lung Cancer, run by Philogen S.p.A. at 2 sites in Italy.

Terminated

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

Official record
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Trial summary

The aim of this feasibility study is to determine the therapeutic potential of the L19SIP antibody, labeled with the radionuclide 131I in combination with radiochemotherapy, for the treatment of patients with newly diagnosed, unresectable, locally-advanced NSCLC following the promising results with this agent in… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
What is being tested?
131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesItaly
Study dates
May 2010to Oct 2012
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

  • Histologically or cytologically confirmed unresectable stage III NSCLC
  • Males or females, age ≥ 18 years
  • Measurable lung lesion defined as at least one lesion that can be accurately and serially measured per the modified RECIST criteria.
  • ECOG performance status < 3
  • Life expectancy of at least 12 weeks
  • Patients eligible for concurrent radiochemotherapy (cisplatin/vinorelbine; 60-66 Gy EBRT) at the discretion of the clinical investigator
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  • Absolute neutrophil count > 1.5 x 109/L, hemoglobin > 9.0 g/dL and platelets > 100 x 109/L
  • Total bilirubin ≤ 30 µmol/L (or ≤ 2.0 mg/Dl)
  • ALT and AST ≤ 2.5 x the upper limit of normal (5.0 x ULN for patients with hepatic involvement with tumor
  • Serum creatinine < 1.5 x ULN
  • All toxic effects of prior therapy must have resolved to ≤ Grade 1 unless otherwise specified above
  • Negative serum pregnancy test (for women of child-bearing potential only) at screening

Who cannot join

  • Patients with metastatic disease
  • Patients amenable for surgical resection of lung tumor lesions
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (TA, Tis \& Ti) or any cancer curatively treated < 5 years prior to study entry
  • History of HIV infection or infectious hepatitis B or C
  • Presence of active infections (e.g. requiring antibimicrobial therapy) or other severe concurrent disease, which, in the opinion of the investigator, would place the patient at undue risk or interfere with the study.
  • Inadequately controlled cardiac arrhythmias including atrial fibrillation
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  • Heart insufficiency (> Grade II, New York Heart Association (NYHA) criteria)
  • Uncontrolled hypertension
  • Ischemic peripheral vascular disease (Grade IIb-IV)
  • History of an acute cardiac event such as myocardial infarction, instable angina pectoris during the last 12 months
  • Severe diabetic retinopathy
  • Active autoimmune disease
  • History of organ allograft or stem cell transplantation
  • Recovery from major trauma including surgery within 4 weeks prior to administration of study treatment
  • Breast feeding female
  • Previous in vivo exposure to monoclonal antibodies for biological therapy in the 6 weeks before administration of study treatment
  • Growth factors or immunomodulatory agents within 7 days of the administration of study treatment (131I-L19SIP application).
  • Hyperthyroidism or autonomous thyroid nodule

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Meldola (Fc)

    Meldola

  • University Hospital Pisa

    Pisa, Tuscany, 56126

Other trials in Italy

About this study

Official title: A Prospective Non-randomized Study of 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy in Patients With Inoperable, Locally-advanced (Stage III) NSCLC

The aim of this feasibility study is to determine the therapeutic potential of the L19SIP antibody, labeled with the radionuclide 131I in combination with radiochemotherapy, for the treatment of patients with newly diagnosed, unresectable, locally-advanced NSCLC following the promising results with this agent in previous clinical studies.

The L19SIP antibody is a fully human antibody, capable of preferential localization around tumor blood vessels while sparing normal tissues. The formation of new blood vessels is a rare event in the adult (with the exception of the female reproductive tract), but it is a characteristic pathological feature for most types of aggressive cancer.

Being tested
131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy
Keywords
I131, L19, antibody, monoclonal, NSCLC, lung, tumor targeting, radioimmunotherapy, Patients with newly diagnosed inoperable, locally-advanced (stage III) NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

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

  • 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent ChemotherapyOther

    Lung tumor irradiation with a total dosage of between 60-66 Gy, fractionated in combination with the following concurrent chemotherapy options:

    1. Cohorts 1, 2 \& 3a is composed of cisplatin i.v. 80 mg/m2 on day 1, and vinorelbine i.v. 25 mg/m2 on day 1, 8, 15 for cycle 1 \& 4. For patients with significant comorbidities, the dose of vinorelbine is reduced to 12.5 mg/m2 during cycles 2 \& 3. Treatment cycles will be repeated every 28 days.
    2. Protocol A (suggested for patients with comorbidities: Carboplatin 70 mg/m2, over 30 min iv, (Day 1-5 ) + Vinorelbine 12.5 mg/m2 as a 5-min bolus iv or short iv-infusion (Day 1, 8, 22), repeated on Day 28.
    3. Protocol B (suggested for patients in good clinical condition): Paclitaxel 50 mg/m2 1 hour iv (Day 1, 15, 22, 29, 36, 43, 50) + Carboplatin AUC 2, 30 min iv on (Day 1, 15, 22, 29, 36, 43, 50).
    • Total treatment duration is 8-16 weeks
Study groups in NCT01124812
Study groupRoleWhat they receive
131I-L19SIPExperimental131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy: Treatment dose of 131I-L19SIP RIT is titrated in cohorts of 3 patients.
Receives: Other: 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy

What is being measured

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

  1. Uptake of 131I-L19SIP or 124I-L19SIP

    The selective uptake of 131I-L19SIP or 124I-L19SIP in lung lesions and dosimetric analysis

    Measured: 2 days

  2. Safety and tolerability of 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy

    Safety will be assessed through physical examinations, vital signs, laboratory tests (including serum chemistries, hematology parameters) and the recording of adverse events. All results from these assessments will be coded using CTCAE v.3 and presented descriptively, indicating frequency and percentage of patients with adverse events, and abnormal laboratory tests. These results will be presented by related/unrelated and overall for the study.

    Measured: 13 months

  3. Dose Limiting Toxicities (DLTs) and Maximum Tolerated Dose/Recommended Dose (MTD/RD) for the combination treatment

    Dose limiting toxicities and maximum tolerated dose/recommended dose for the combination treatment

    Measured: 4 weeks

Secondary outcomes (2)

  1. Overall response rate

    Intrapulmonal, extra pulmonal and overall response rate

    Measured: 1 year

  2. Overall survival

    Measured: 1 year

Timeline

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

  1. First posted17 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionAug 2011
  4. Study completionOct 2012

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
Single group
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01124812
Sponsor's protocol ID
PH-L19SIPI131-04/09
Other IDs
2009-017072-24, 2009
Status last verified
Jun 2012
First submitted
12 May 2010
Last updated
26 Oct 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy in people with Non Small Cell Lung Cancer, run by Philogen S.p.A. at 2 sites in Italy.

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 12 inclusion and 18 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 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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. 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?

Uptake of 131I-L19SIP or 124I-L19SIP (time frame: 2 days). The study lists 3 primary outcomes in all. 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 NCT01124812.

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 26 Oct 2012.

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