Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01124812
Other study ID # PH-L19SIPI131-04/09
Secondary ID 2009-017072-24
Status Terminated
Phase Phase 1
First received May 12, 2010
Last updated October 25, 2012
Start date May 2010
Est. completion date October 2012

Study information

Verified date June 2012
Source Philogen S.p.A.
Contact n/a
Is FDA regulated No
Health authority Italy: National Institut of Health (Istituto Superiore di Sanità)Italy: Ethics Committee
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date October 2012
Est. primary completion date August 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

- 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Other:
131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy
Lung tumor irradiation with a total dosage of between 60-66 Gy, fractionated in combination with the following concurrent chemotherapy options: 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. 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. 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

Locations

Country Name City State
Italy Irst - Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori - Meldola (Fc) Meldola
Italy University Hospital Pisa Pisa Tuscany

Sponsors (1)

Lead Sponsor Collaborator
Philogen S.p.A.

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Uptake of 131I-L19SIP or 124I-L19SIP The selective uptake of 131I-L19SIP or 124I-L19SIP in lung lesions and dosimetric analysis 2 days No
Primary 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. 13 months Yes
Primary 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 4 weeks No
Secondary Overall response rate Intrapulmonal, extra pulmonal and overall response rate 1 year No
Secondary Overall survival 1 year No
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05707286 - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Completed NCT01945021 - Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC Phase 2
Completed NCT04487457 - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Terminated NCT04022876 - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Phase 1
Recruiting NCT05898763 - TEIPP Immunotherapy in Patients With NSCLC Phase 1/Phase 2
Recruiting NCT05532696 - Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients Phase 1/Phase 2
Completed NCT04311034 - A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer Phase 1/Phase 2
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Terminated NCT03257722 - Pembrolizumab + Idelalisib for Lung Cancer Study Phase 1/Phase 2
Completed NCT00349089 - Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy Phase 2
Completed NCT05116891 - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04571632 - Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors Phase 2
Terminated NCT03599518 - DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer Phase 1
Not yet recruiting NCT06020989 - Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy Phase 2
Withdrawn NCT03982134 - PDR001 + Panobinostat for Melanoma and NSCLC Phase 1
Withdrawn NCT03574649 - QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer Phase 2
Withdrawn NCT02844140 - DE-CT in Lung Cancer Proton Therapy N/A
Completed NCT03780010 - Study of TRC105 + Paclitaxel/Carboplatin and Bevacizumab in Patients With NSCLC Phase 1