Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

All Drugs and Chemicals

Antineoplastic Agents

Antirheumatic Agents

Micronutrients

Anti-Infective Agents

Antibodies

Rituximab

Immunoglobulins

Iodine

Cadexomer iodine

Tositumomab I-131

Immunoglobulins, Intravenous

Immunologic Factors

Anti-Infective Agents, Local

Trace Elements

Patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of Anti-B1 Antibody (35 mg) containing 5 mCi of Iodine-131 (dosimetric dose). Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Patients will then receive an infusion of unlabeled Anti-B1 Antibody (450 mg) followed by an infusion of 35 mg Anti-B1 Antibody containing a patient-specific dose of Iodine-131 calculated to deliver a 75 cGy total body radiation dose (therapeutic dose). Patients who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy; obese patients will be dosed based upon 137% of their lean body mass. Patients will be treated with a thyroid blocking agent 24 hours prior to the dosimetric dose and continuing for 14 days following the therapeutic dose.

Anti-B1 Antibody and Iodine-131 Anti-B1 Antibody (Tositumomab and Iodine I 131 Tositumomab)

GSK Clinical Trials

This is a single-arm, open-label, multicenter study of Iodine I-131 Anti B1 Antibody (Tositumomab and Iodine I 131 Tositumomab) for treatment of non-Hodgkin's lymphoma (NHL) who were previously treated with rituximab antibody. Patients must have been treated with at least 4 doses of rituximab and have progressed during or following rituximab therapy.

Patients will undergo two dosing phases of study. In the first phase, termed the "dosimetric dose", patients will receive an infusion of unlabeled Anti-B1 Antibody (450 mg) over 70 minutes immediately followed by a 30-minute infusion of Anti-B1 Antibody (35 mg) which has been radiolabeled with 5 mCi of Iodine-131. Whole body gamma camera scans will be obtained on Day 0; Day 2, 3, or 4; and Day 6 or 7 following the dosimetric dose. Using the dosimetric data from three imaging timepoints, a patient-specific dose of Iodine-131 will be calculated to deliver the desired total body dose of radiotherapy. In the second phase, termed the "therapeutic dose", patients will receive a 70-minute infusion of unlabeled Anti-B1 Antibody (450 mg) immediately followed by a 30-minute infusion of 35 mg Anti-B1 Antibody labeled with a patient-specific dose of Iodine-131 to deliver a whole body dose of 75 cGy to patients with no hematologic risk factors. Patients who have platelet counts of 100,001-149,999 cells/mm3 will receive 65 cGy and patients who are obese will be dosed based upon 137% of their lean body mass. Patients will be treated with either saturated solution potassium iodide (SSKI), Lugol's solution, or potassium iodide tablets starting at least 24 hours prior to the first infusion of the Iodine-131 Anti-B1 Antibody (i.e., dosimetric dose) and continuing for 14 days following the last infusion of Iodine-131 Anti-B1 Antibody (i.e., therapeutic dose).

The endpoints of the study are to determine the response rate, complete response rate, duration of response, and time to progression or death, based on both a Masked Independent Randomized Radiographic and Oncologic Review (MIRROR) panel and the Investigators, and the Investigators' assessment of safety and survival of survival of Iodine-131 Anti-B1 Antibody therapy in NHL patients who have previously been treated with rituximab.

Study of Iodine-131 Anti-B1 Antibody for Patients With Non Hodgkin's Lymphoma Who Have Previously Received Rituximab

Phase II Study of Iodine-131 Anti-B1 Antibody for Non Hodgkin's Lymphoma Patients Who Have Previously Received Rituximab

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Responses had to be confirmed by 2 separate evaluations occurring \>=4 weeks apart. Par. with confirmed response include those with Complete Response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease), Clinical Complete Response (CCR: complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present), or Partial Response (PR: \>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions).

CR is defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease.

CCR is defined as the complete resolution of all disease-related symptoms; residual foci, thought to be residual scar tissue, are present. Generally, an unchanging lesion =\<2 centimeters (cm) in diameter by radiographic evaluation or =\<1 cm in diameter by physical examination can be considered scar tissue. The extent of disease must be unchanged or decreased upon follow-up evaluations. If the extent of disease was unchanged or if further decreases occurred for 6 months or longer, the participant was reclassified as having a CR.

Confirmed PR is defined as a \>=50 percent reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions, with no new lesions.

Response duration is defined as the time from the first documented response until disease progression.

Response duration is defined as the time from the first documented response until disease progression. Disease progression is defined as a \>=25% increase from the nadir value of the sum of the products of the longest perpendicular diameters of all measureable lesions or the appearance of any new lesion. Individual lesions must be \>2 centimeters (cm) in diameter by radiographic evaluation or \>1 cm in diameter by physical examination.

Response duration is defined as the time from the first documented response until progressive disease.

Response corresponds to the best response evaluation (ordered by CR, CCR, and PR) and does not require subsequent confirmation. Participants with CR, CCR, or PR are considered to be responders. A prior response to rituximab refers to a CR, CCR, or PR after rituximab treatment before enrollment into Study BEX104507.

Duration of response is defined as the time from the first documented response to disease progression.

Progression-free survival is defined as the time from treatment start to the first documented occurrence of disease progression or death.

Progression-free survival or time to progression is defined as the time from the dosimetric dose to the first documented occurrence of disease progression or death.

Overall survival is defined as the time from the treatment start date to the date of death from any cause.

An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The Investigator assessed whether the adverse event was possibly or probably related to study drug. In addition, all laboratory-derived hematologic toxicities were assumed to be possibly or probably related to study drug.

An infection is the colonization of a host organism by a parasite species. Infecting parasites seek to use the host's resources to reproduce, often resulting in disease. Specimen samples of the body fluid are cultured for testing whether the infectious organism is present and grown in the culture media to assess the growth pattern of the organisms present in the specimen. The culture results could be positive or negative. The positive culture results indicate that the tested participant has the infection under investigation, in which case therapeutic treatment with anti-infective is required.

Anti-infectives are capable of acting against infection, by inhibiting the spread of an infectious agent or by killing the infectious agent outright. Anti-infective is a general term that encompasses antibacterials, antibiotics, antifungals, antiprotozoans, and antivirals.

An SAE is any event occurring at any dose that results in any of the following: death, a life-threatening adverse drug experience (ADE; at immediate risk of death from the experience as it occurred), inpatient hospitalization/prolongation of existing hospitalization, a persistent/significant disability/incapacity, or a congenital anomaly/birth defect. Medical events that may not result in death, be life-threatening, or require hospitalization may be considered to be a serious ADEs when based upon appropriate medical judgment. Relatedness was based on the investigator's medical judgement.

Nadir is defined as the lowest laboratory value recorded following the administration of the study medication. Time to recovery to baseline in hematologic laboratory evaluations is the time required for recovery from nadir values to baseline values.

Nadir is defined as the lowest laboratory value recorded following the administration of study medication. ANC is a measure of the number of neutrophil granulocytes present in the blood. Neutrophils are a type of white blood cell that fights against infection.

Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Hemoglobin is the iron-containing oxygen-transport metalloprotein in the red blood cells.

Nadir is defined as the lowest laboratory value recorded following the administration of study medication. Platelets and WBCs are types of blood cells.

Adverse events were graded using the Common Toxicity Criteria from the Cancer Therapy Evaluation Program, Division of Cancer Therapy, National Cancer Institute. Grades: 0 = No adverse event or within normal limits; 1 = Mild adverse event; 2 = Moderate adverse event; 3 = Severe and undesirable adverse event; 4 = Life-threatening or disabling adverse event; 5 = Death related to adverse event.

GlaxoSmithKline

Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray \[cGy\] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.

TST and Iodine I 131 TST

Baseline characteristics are summarized for the Intent-to-Treat (ITT) Population, comprised of all participants who were enrolled into the study and received at least one dose of study drug.

Age, Continuous

Sex: Female, Male

White

Hispanic

Asian

Black

Race/Ethnicity, Customized

GSK Response Center

Intent-to-Treat (ITT) Exposed Population: all participants who were enrolled into the study and received at least one dose of study drug. Only those participants evaluable for confirmed response were analyzed.

Number of Participants (Par.) With Confirmed Response as Assessed by the Investigator

ITT Exposed Population. Only those participants evaluable for confirmed response were analyzed.

Number of Participants With Confirmed Complete Response (CR) as Assessed by the Investigator

ITT Exposed Population. Only those participants evaluable for CR + CCR were analyzed.

Number of Participants With Confirmed Complete Response Plus Clinical Complete Response (CR + CCR) as Assessed by the Investigator

ITT Exposed Population. Only those participants evaluable for confirmed PR were analyzed.

Number of Participants With Confirmed Partial Response (PR) as Assessed by the Investigator

ITT Exposed Population. Only those participants with confirmed response and those who experienced progressive disease were analyzed.

Duration of Response for All Confirmed Responders (CR, CCR, or PR) as Assessed by the Investigator

ITT Exposed Population. Only those participants with confirmed CR and those who experienced progressive disease were analyzed.

Duration of Response for Confirmed CR as Assessed by the Investigator

ITT Exposed Population. Only those participants with confirmed CR + CCR response and those who experienced progressive disease were analyzed.

Duration of Response for CR and CCR as Assessed by the Investigator

ITT Exposed Population. Only those participants with confirmed PR and those who experienced progressive disease were analyzed.

Duration of Response for All Confirmed Partial Responders as Assessed by the Investigator

Responders with prior response to Rituximab; n=16

Responders w/o prior response to Rituximab; n=24

Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated.

Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Responders in This Study

Responders with prior response to Rituximab; n=12

Responders w/o prior response to Rituximab; n=16

Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with a response were analyzed.

Duration of Response for All Participants Classified as Responders With or Without a Prior Response to Rituximab

Number of Participants With or Without (w/o) a Prior Response to Rituximab (Before Entry Into This Study) Who Were Classified as Having a Complete Response (CR) in This Study

Responders with prior response to Rituximab; n=5

Responders w/o prior response to Rituximab; n=4

Subset of ITT Exposed Population. Only those participants who had received rituximab prior to entry into this study were evaluated. Only those participants with confirmed response were analyzed.

Duration of Response for All Participants With CR With or Without a Prior Response to Rituximab

Progression-free Survival for Participants With or Without a Prior Response to Rituximab

All responders, n=30

CR + CCR, n=15

PR, n=11

ITT Exposed Population. Only those participants who experienced progression were evaluated.

Time to Progression of Disease or Death in All Responders, Participants With CR + CCR, and Participants With PR as Assessed by the Investigator

Absolute Neutrophil Count (ANC) <1000 cells/cm^3

White Blood Cells (WBC) <2000 cells/cm^3

Platelets <50000 cells/cm^3

Hemoglobin <8.0 grams/deciliter (g/dL)

Pyrexia

Fatigue

Chills

Edema Peripheral

Asthenia

Malaise

Arthralgia

Myalgia

Nausea

Vomiting

Anaemia

Thrombocytopenia

Neutropenia

Pruritus

Rash

Epistaxis

Productive Cough

Decreased Appetite

Upper Respiratory Tract Infection

Myelodysplastic Syndrome/ Acute Myeloid Leukemia

Headache

Number of Participants With the Indicated Adverse Events (AE) Possibly or Probably Related to Study Drug and Experienced by at Least 5% of Participants

Any Infection; n=40

No Infection; n=40

Meningitis; n=22

Pyelonephritis; n=22

Sepsis; n=22

Pneumonia; n=22

Endocarditis/ Pericarditis; n=22

Peritonitis; n=22

Other Infections; n=22

Number of Participants With the Indicated Type of Infection

Anti-infective Administered

Anti-infective Not Administered

ITT Exposed Population. Only those participants who had infection during the study and during the follow-up period were analyzed.

Number of Participants With an Infection for Which Anti-infectives Were Administered

Myelodysplastic syndrome/Acute myeloid leukemia

Malignant hepatobiliary neoplasm

Squamous cell carcinoma

Tumor lysis syndrome

Anemia

ITT Exposed Population. All participants who experienced any SAE were analyzed.

Number of Participants With Serious Adverse Events (SAE) Related to Study Drug

Time to nadir ANC, n=40

Time to nadir hemoglobin, n=40

Time to nadir platelets, n=40

Time to nadir WBC count, n=40

Time to recovery to baseline ANC, n=32

Time to recovery to baseline hemoglobin, n=29

Time to recovery to baseline platelets, n=29

Time to recovery to baseline WBC count, n=28

Time to Nadir and Time to Recovery to Baseline in Hematologic Laboratory Evaluations

Nadir Values for ANC, a Hematologic Parameter

Nadir Values for Hemoglobin, a Hematologic Parameter

Platelets (10000 cells/microliter)

WBC count (1000 cells/microliter)

Nadir Values for Hematologic Parameters Platelets and WBC Count

Hemoglobin

Platelets

WBC count

Number of Participants With the Indicated Grade 3 or Grade 4 Hematologic Toxicities

ANC, n=16

Hemoglobin, n=5

Platelets, n=10

WBC count, n=15

ITT Exposed Population. All participants with Grade 3 or Grade 4 hematologic toxicities were analyzed.

Duration of the Indicated Grade 3 or Grade 4 Hematologic Toxicities

ITT Exposed Population. Only those participants who died during the study and during the follow-up period were analyzed.

Overall Survival

Dosimetric and Therapeutic Treatment

Long-Term Follow-Up

Pheochromocytoma

Paraganglioma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Paragangliomas 1

Neuroendocrine Tumor

Neuroepithelioma

Radiopharmaceuticals

3-Iodobenzylguanidine

Enzyme Inhibitors

Dosing of Ultratrace iobenguane I 131 began at 6.0 mCi/kg and escalated in 1.0 mCi/kg increments in order to establish the MTD. The MTD is the dose immediately below the level at which escalation stops due to dose-limiting toxicity (DLT). An additional 3 patients are to be treated at the MTD, for a total of 6.

Phase I: Dose escalation protocol Phase II: Treatment schedule at therapeutic dose

Ultratrace Iobenguane (MIBG) I 131

Molecular Insight Pharmaceuticals

The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.

This was originally designed as a phase 1/2 study. The phase 1 patients received a small dose of study drug to see if the tumors absorb the drug. If the patient's tumors absorbed the drug, then the patient received one therapeutic dose. In the phase 1 portion, the study employed a 3 + 3 dose escalation design. Enrollment in the phase 1 portion was to be completed once researches believed that they found the highest dose that they could give patients without causing unacceptable toxicity. This dose is called the maximum tolerated dose (MTD). Following discussions with the Food and Drug Administration (FDA) that occurred during the dose escalation stage of the study, the protocol was amended to conclude the trial upon the identification of the MTD. The Phase 2 safety/ efficacy stage of the study was conducted with modifications of the primary endpoint as Protocol MIP IB12B, with Special Protocol Assessment Agreement with the FDA in March 2009.

Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

A Phase I Study Evaluating the Maximum Tolerated Dose, Dosimetry, Safety, and Efficacy of Ultratrace Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

Although no primary efficacy endpoint was defined for this study, the MTD of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma (a safety rather than an efficacy parameter) is the primary objective.

Molecular Insight Pharmaceuticals, Inc.

Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Iodine-131 Anti-B1 Antibody for Patients With Non Hodgkin's Lymphoma Who Have Previously Received Rituximab	NCT00996593	Lymphoma, Non-H...	Anti-B1 Antibod...	18 Years -	GlaxoSmithKline
Study of Iodine-131 Anti-B1 Antibody for Patients With Non Hodgkin's Lymphoma Who Have Previously Received Rituximab	NCT00996593	Lymphoma, Non-H...	Anti-B1 Antibod...	18 Years -	GlaxoSmithKline
Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma	NCT00458952	Pheochromocytom... Paraganglioma	Ultratrace Iobe...	18 Years -	Molecular Insight Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for i 131

Every month we try and update this database with for i 131 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 i 131

Every month we try and update this database with for i 131 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 i 131 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.