All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Phase I: Multicentre, open-label, two-step single-arm dose escalation study in sequential cohorts of patients with cancer.

Phase II: Prospective, open-label, single-arm, multicentre study of 131I-L19SIP, given at the RD as determined in phase I.

Dosimetric evaluation with 131I-L19SIP will be performed to assess eligibility for Radioimmunotherapy.

Phase I: Patients eligible for Radioimmunotherapy will receive escalating doses of therapeutic 131I-L19SIP administration (intravenously) at the following dosages (expressed in mCi/m2): 111, 139 and 167.

131I-L19SIP Radioimmunotherapy (RIT)

Giuliano Mariani, Prof

Tim Meyer, Dr

The aim of this Study Protocol is to provide a basis for the clinical development of 131I-L19SIP as an anti-cancer therapeutic agent, following the promising results of a Phase I study.

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 (exception made for the female reproductive cycle), but is a pathological feature of most aggressive types of cancer. The study aims at determining the therapeutic potential of the L19SIP antibody in SIP format, labelled with the radionuclide 131I, for the treatment of patients with different cancer types. The study follows a Phase I study performed with 131I-L19SIP in over 30 patients with cancer, which has shown an excellent tolerability at radioactive doses as high as 150 mCi and therapeutic benefit for some patients enrolled in the study.

Radioimmunotherapy With 131I-L19SIP in Patients With Cancer

A PHASE I/II DOSE FINDING AND EFFICACY STUDY OF THE TUMOUR TARGETING HUMAN 131I-L19SIP MONOCLONAL ANTIBODY IN PATIENTS WITH CANCER

Establishment of the maximum tolerated dose (MTD) and the recommended dose (RD) for the radiolabelled L19SIP monoclonal antibody.

Investigation of the antitumour activity of 131I-L19SIP at the RD, in patients with advanced cancer.

Evaluation of the pharmacokinetics of 131IL19SIP.

Determination of the overall safety profile of the iodinated antibody characterized by type, frequency, severity, timing and relationship to study therapy of adverse events and laboratory abnormalities in the first and following cycles in all patients receiving a therapeutic dose.

Evaluation of the overall Response Rate (ORR) for all patients having received a therapeutic dose.

Evaluation of the progression free survival (PFS) for all patients having received a therapeutic dose.

Evaluation of the survival rate at 6 and 12 months and overall survival time for all patients having received a therapeutic dose.

Philogen S.p.A.

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Vinorelbine

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

131I-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.

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

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

Giovanni Paganelli, Dr

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.

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

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

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.

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

Intrapulmonal, extra pulmonal and overall response rate

Gland and Hormone Related Diseases

Thyroid Neoplasms

Thyroid Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

* Administration of 1.1 GBq of I131 is given after the second intramuscular injections of rhTSH (0.9 mg). A whole body scan (WBS) is performed 2 to 5 days after the administration or I131 with determination of the neck uptake.
* Follow-up consists in:

  * 10 (+/- 2 months) after randomization: neck ultrasound + a serum Tg measurement after rhTSH stimulation
  * 2 years (+/- 2 months) after randomization: serum Tg measurement under LT4 treatment (Tg/LT4)
  * 3 years (+/- 2 months) after randomization: neck ultrasound and a serum Tg/LT4
  * 4 years (+/- 2 months) after randomization: a serum Tg/LT4
  * 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  * 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  * 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
  * 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4

Patients randomized in the follow up group neither received 131I nor rhTSH. Patients will undergo the same followup procedures as patients randomized to the ablation group, except that at 10 months after randomization, Tg will be measured under LT4 treatment and not after rhTSH stimulation.

Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment

rhTSH stimulation

An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.

I131

* 10 (+/- 2 months) after randomization: a neck ultrasound and a serum Tg measurement after rhTSH or LT4 stimulation
* 2 years (+/- 2 months) after randomization: a serum Tg measurement under LT4 treatment (Tg/LT4)
* 3 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
* 4 years (+/- 2 months) after randomization: a serum Tg/LT4
* 5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
* 8 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
* 10 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
* 12 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4

Follow up

Open-label randomized phase III trial, using a non-inferiority comparison design. After randomization,patients will receive either post-operative radioiodine ablation with an activity of 1.1 GBq (30 mCi) after stimulation by rhTSH, and then be followed-up (ablation group) or be followed-up (without postoperative radioiodine ablation) (follow-up group).

The objective is to assess the non-inferiority of the proportion of patients without tumor-related event evaluated at three years after randomisation in the absence of radioiodine ablation (follow-up group) compared to the ablation group, in patients with low-risk differentiated thyroid cancer treated with total thyroidectomy with or without lymph node dissection (pT1am N0 or Nx, pT1b N0 or Nx)

Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

Gustave Roussy, Cancer Campus, Grand Paris

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphosarcoma

Phase I: Multicentre, open-label, two-step singlearm dose escalation study in sequential cohorts of patients with cancer.

Phase II: Prospective, open-label, single-arm, multicentre study of 131I-F16SIP, given at the RD of 55.5 mCi/m2, as determined in phase I.

* Dosimetric evaluation with 131I-F16SIP or 124I-F16SIP will be performed to assess eligibility for Radioimmunotherapy.
* Patients eligible for Radioimmunotherapy will receive 55.5 mCi/m2 as established in the Phase I part of the study. A single dose of 5 to 10 mg of 131I-F16SIP will be administered intravenously (I.V).

131I-F16SIP Radioimmunotherapy (RIT)

Maddalena Sansovini, Dr

The aim of this Study Protocol is to provide a basis for the clinical development of 131I-F16SIP as an anti-cancer therapeutic agent.

The study follows and is greatly motivated by the promising results of a Phase I/II study with a similar investigational drug developed by our Company, 131I-L19SIP, in several Italian centers.

The F16SIP antibody is a fully human antibody, capable of preferential localization around tumour blood vessels while sparing normal tissues. The formation of new blood vessels is a rare event in the adult (exception made for the female reproductive cycle), but is a pathological feature of most aggressive types of cancer. The study aims at determining the therapeutic potential of the F16 antibody in SIP format,labelled with the radionuclide 131I, for the treatment of patients with different cancer types.

A Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer

A Phase I/II Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer

Establishment of the maximum tolerated dose (MTD), a recommended dose (RD) for the phase II part, and the safety of dosimetric and therapeutic administration of escalating dosages of the human radiolabeled antibody 131I-F16SIP.

Investigation of the antitumour activity of 131I-F16SIP at the RD.

Evaluation of the pharmacokinetics of 131I-F16SIP and 124I-F16SIP.

Determination of the overall safety profile of the iodinated antibody characterized by type, frequency, severity, timing and relationship to study therapy of adverse events and laboratory abnormalities in the first and eventual following administrations in all patients receiving a therapeutic dose.

Eudax S.r.l.

Symptoms and General Pathology

Recurrence

Micronutrients

Anti-Infective Agents

Iodine

Cadexomer iodine

Low dose RAI (radioactive iodine I-131, 30mCi) will be given to ablate remnant thyroid tissue.

Diagnostic RAI (radioactive iodine I-123, 2-6mCi) will be given to achieve postRAI scan.

I123

Eun Kyung Lee, M.D.,Ph.D.

The researchers investigated the rate of biochemical remission in patients without radioactive iodine therapy compared to patients with low dose radioactive iodine treatment in differentiated thyroid cancer patients who underwent total thyroidectomy.

Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer

Phase Ⅱ Non-randomized Multicenter Controlled Trial About Effect of Remnant Ablation Therapy on the Recurrence in Low-risk Differentiated Thyroid Cancer Patients

National Cancer Center, Korea

M.D., Ph.D.

Nervous System Diseases

Neoplasm Metastasis

Neoplasms, Second Primary

Brain Neoplasms

Neoplastic Processes

Central Nervous System Neoplasms

Nervous System Neoplasms

Brain Diseases

Central Nervous System Diseases

131I-L19SIP Radioimmunotherapy (RIT) in Combination With Whole Brain Radiation Therapy (WBRT)

* Patients will be treated with WBRT administering a total dosage of 30 Gy in fractions of 3 Gy
* Dosimetric evaluation with 131I-L19SIP or 124I-L19SIP will be performed to assess eligibility for RIT.
* Patients eligible for RIT will receive a therapeutic dose of 131I-L19SIP.
* Total treatment duration is up to 4 weeks

Secondo Lastoria, Dr

Paul Mullholand, Dr

The aim of this Proof of Concept study is to determine the therapeutic potential of the L19SIP antibody, labeled with the radionuclide 131I in combination with external beam radiation, for the treatment of patients with multiple brain metastases 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 (exception made for the female reproductive cycle), but is a pathological feature in most aggressive types of cancer. The presented study follows a Phase I and a subsequent Phase I/II dose finding and efficacy study with the same agent in patients with a variety of cancers where 131I-L19SIP had shown an excellent tolerability and therapeutic benefit for some patients enrolled in the study.

131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiation in Patients With Multiple Brain Metastases From Solid Tumors

A Prospective Non-randomized Study of 131I-L19SIP Radioimmunotherapy (RIT) in Combination With Whole Brain Radiation Therapy (WBRT) in Patients With Multiple Brain Metastases From Solid Tumors

Selective uptake of 131I-L19SIP or 124I-L19SIP in brain lesions

Safety will be assessed through physical examinations, vital signs, laboratory tests (including serum chemistries, hematology parameters) and the recording of adverse events. Treatment emergent adverse events will be summarized by CTCAE version 3 (and if possible by the RTOG/EORTG scale) and worse grade for all treated patients. Laboratory values and change in vital signs will be summarized.

Intracranial, extra cranial and overall response

GPA score will be assessed at the screening visit, during treatment and follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Radioimmunotherapy With 131I-L19SIP in Patients With Cancer	NCT01242943	Patients With C...	131I-L19SIP Rad...	18 Years - 75 Years	Philogen S.p.A.
131I-L19SIP Radioimmunotherapy Combined With Radiochemotherapy in Patients With Locally-advanced Non Small Cell Lung Cancer (NSCLC)	NCT01124812	Non Small Cell ...	131I-L19SIP Rad...	18 Years -	Philogen S.p.A.
Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?	NCT01837745	Low Risk Differ...	rhTSH stimulati... I131 Follow up	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
A Dose Finding and Efficacy Study of the Tumour Targeting Human 131I-F16SIP Monoclonal Antibody in Patients With Cancer	NCT01240720	Cancer	131I-F16SIP Rad...	18 Years -	Philogen S.p.A.
Minimize Radioactive Iodine Ablation Of Remnant Thyroid in Differentiated Thyroid Cancer	NCT02418247	Thyroid Neoplas...	I131 I123	18 Years - 79 Years	National Cancer Center, Korea
131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiation in Patients With Multiple Brain Metastases From Solid Tumors	NCT01125085	Brain Metastase...	131I-L19SIP Rad...	18 Years -	Philogen S.p.A.
Radioimmunotherapy With 131I-L19SIP in Patients With Cancer	NCT01242943	Patients With C...	131I-L19SIP Rad...	18 Years - 75 Years	Philogen S.p.A.

Spots Global Cancer Trial Database for i131

Every month we try and update this database with for i131 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for i131

Every month we try and update this database with for i131 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for i131 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.