Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Digestive System Diseases

Gland and Hormone Related Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Breast Neoplasms

Pancreatic Neoplasms

Stomach Neoplasms

Ovarian Neoplasms

Peritoneal Neoplasms

Breast Diseases

Skin Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Stomach Diseases

Abdominal Neoplasms

Peritoneal Diseases

Pancreatic Cancer

Ovarian Cancer

Stomach Cancer

Antineoplastic Agents

All Drugs and Chemicals

Natriuretic Agents

Trastuzumab

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Furosemide

Immunoglobulins

Immunoglobulins, Intravenous

Immunologic Factors

Antineoplastic Agents, Immunological

In preparation for the study, patients screened and eligible will have a peritoneal catheter placed and the evening prior to the injection of the labeled antibody will receive furosemide. Herceptin will be administered IV followed by a single IP infusion of ²¹²Pb-TCMC-Trastuzumab. Serial sampling of blood, urine, and dosimetry will be performed following treatment to determine the toxicity, pharmacokinetics, immunogenicity, and antitumor effects.

The starting dose level will be 200 μCi/m² of ²¹²Pb-TCMC-Trastuzumab. Three to six patients will be treated at each dose level, and dose escalation will proceed if no more than 1 out of 6 patients in a cohort experiences dose limiting toxicity. Six patients will be treated at the maximum tolerated dose.

²¹²Pb-TCMC-Trastuzumab

trastuzumab

Ruby F Meredith, M.D., Ph.D.

Monoclonal antibodies can transport and deliver radioactive elements capable of releasing sufficient amounts of energy to destroy tumor cells. In this clinical trial, we will study alpha particle radio immunotherapy using lead-212 (²¹²Pb), an isotope with a short path length targeted to malignant cells by the trastuzumab antibody, as a potential treatment for metastatic diseases.

This Phase I trial is designed to determine the toxicity profile of ²¹²Pb-TCMC-Trastuzumab, its dose-limiting toxicities, and its anti-tumor effects in patients with HER-2 positive intraperitoneal cancers.

Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy

Phase I Trial of Intraperitoneal ²¹²Pb-TCMC-Trastuzumab for HER-2 Expressing Malignancy

Adverse events considered dose limiting toxicity:

* Grade 3 elevations of ALP, bilirubin, ALT, or AST lasting ≥7 days
* Grade 3 elevations of serum creatinine within 6 weeks of treatment
* Grade 2 elevations of serum creatinine lasting ≥7 days that occur after 6 weeks
* Grade 3 proteinuria
* Any other Grade 3 or 4 non-hematologic toxicity
* Grade 4 neutropenia lasting ≥7 days or febrile neutropenia of any duration
* Grade 3 thrombocytopenia that fails to recover to ≤ Grade 2 at 6 weeks
* Grade 4 thrombocytopenia lasting ≥7 days or thrombocytopenia accompanied by bleeding

Orano Med LLC

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Anti-Infective Agents

Pharmaceutical Solutions

Antirheumatic Agents

Etoposide

Cytarabine

Rituximab

Melphalan

Lenograstim

Etoposide phosphate

Carmustine

Fotemustine

Infusion of 90Y Ibritumomab Tiuxetan if the patient has less than 25% BM infiltration at the pre-consolidation restaging (0.4 mCi/kg if platelets ≥150,000/mmc, 0.3 mCi/kg if platelets are between 100.000 and 150,000/mmc). Zevalin® will be delivered as per indications and should thus be provided at expenses following regular supplies procedures.

BEAM conditioning regimen (or in alternative FEAM regimen with fotemustine to replace BCNU) and reinfusion of CD34+ cells of ≥ 2x106/Kg CD34+ day 0 (optimal dose to reinfuse 4x106/Kg CD34+). G-CSF 5 mcg/Kg from day 2 until ANC\>1500/mmc. Patients who failed mobilization will directly proceed to rituximab maintenance

Infusion of 90Y Ibritumomab Tiuxetan if the patient has less than 25% BM infiltration at the pre-consolidation restaging (0.4 mCi/kg if platelets ≥150,000/mmc, 0.3 mCi/kg if platelets are between 100.000 and 150,000/mmc).

ZEVALIN

BEAM REGIMEN day -6 Carmustine\* 300 mg/ m2 i.v. in 250ml dextrose 5% solution

from day -5 to day -2 Cytarabine 200 mg/m2 i.v. every 12 hours in 250 ml dextrose 5% solution, 250 ml/hr Etoposide 100 mg/m2 i.v. every 12 hours in 250 ml dextrose 5% solution, 250 ml/hr day -1 Melphalan 140 mg/m2 i.v. in 100ml saline solution in 200 ml/hr

day 0

UReinfusion of autologous stem cells following this rules:

1. Patient collecting ≥6x106 CD34+ cells/kg use \>4x106 CD34+ cells/kg for ASCT and keep \>2x106 CD34+ cells/kg for back up;
2. Patient collecting 4-6x106 CD34+ cells/kg use \>2x106 CD34+ cells/kg for ASCT and keep \>2x106 CD34+ cells/kg for back up;
3. Patient collecting 2-4x106 CD34+ cells/kg use all CD34+ cells for ASCT and keep no back up.

day 2 Filgrastim or Lenograstim 5μg/Kg s.c. until ANC \> 1500/mmc

BEAM

Umberto Vitolo

Marco Ladetto

This is a Phase III, multicenter, open-label, randomized and controlled study to compare the efficacy of a consolidation therapy with RIT versus ASCT in patients with FL in CR or PR after second or third line chemotherapy supplemented with rituximab.

This is a Phase III, multicenter, open-label, randomized and controlled study to compare the efficacy of a consolidation therapy with RIT vs. ASCT in patients with FL in CR or PR after second or third line chemotherapy supplemented with rituximab. Patients with FL will be eligible for screening at the time of relapsed or refractory disease after two or less chemotherapy lines at least one containing rituximab.

This study will be conducted in six steps as follows. Screening Phase, Enrolment and Induction chemotherapy (STEP I) Randomization (STEP II) Stem cell mobilization and collection (STEP III) Consolidation (RIT vs ASCT) (STEP IV) Maintenance (STEP V) Follow-up Phase (STEP VI)

A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)

A Phase III Multicenter,Randomized Study Comparing Consolidation With 90yttrium-Labeled Ibritumomab Tiuxetan (Zevalin®) Radioimmunotherapy Vs Autologous Stem Cell Transplantation (ASCT) in Patients With Relapsed/Refractory Follicular Lymphoma (FL) Aged 18-65 Years

PFS will be defined as the time between the date of randomization and the date of disease progression, relapse or death from any cause.

OS will be defined as the time between the date of randomization and the date of death from any cause.

EFS will be measured from the date of randomization to the date of any treatment failure including death, disease progression or relapse, discontinuation of treatment for any reason (toxicity, patient preference, initiation of new treatment without documented progression).

TFS will be defined as the time between the date of the end of primary treatment until the institution of the next unplanned chemotherapy in randomized population.

PFS will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause.

OS will be defined as the time between the date of enrolment and the date of death from any cause

Proportion of CR according to the Cheson 2007 response criteria at the end of consolidation phase.

ORR at the end of the consolidation phase is defined as Complete Response (CR) or Partial Response according to the Cheson 2007 response criteria.

Incidence of grade 3 or higher Toxicity measured by CTCAE v.4.03 during therapy.

Rate of MR will be defined as the proportion of patients achieving PCR negativity after the consolidation phase and during follow up.

Rate of conversion will be defined as the proportion of patients with baseline PCR-positivity converting to PCR-negativity during treatment.

Rate of molecular relapse will be defined as the proportion of patients with PCR-negativity after treatment converting to PCR-positivity during the first two years of follow-up.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy	NCT01384253	Breast Neoplasm... Peritoneal Neop... Ovarian Neoplas... Pancreatic Neop... Stomach Neoplas...	²¹²Pb-TCMC-Tras... trastuzumab	19 Years -	Orano Med LLC
A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)	NCT01827605	Relapsed Follic...	ZEVALIN BEAM	18 Years - 65 Years	Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for rit

Every month we try and update this database with for rit 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 rit

Every month we try and update this database with for rit 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 rit 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.