Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.

BAY 43-9006 (Sorafenib)

Giuseppe Giaccone, M.D., Ph.D.

This study will investigate the effects and side effects of BAY 43-9006 in patients with advanced, recurrent, or refractory non-small cell lung cancer (NSCLC). BAY 43-9006 is one of a new class of anticancer agents known as bi-aryl ureas.

Patients 18 years of age and older with NSCLC that has recurred or progressed after one regimen of chemotherapy may be eligible for this study. Candidates are screened with a medical history and physical examination; blood tests; tumor biopsy (see below); chest x-ray; electrocardiogram; and imaging studies, including positron emission tomography-computed tomography (PET-CT, see below) and dynamic, contrast-enhanced MRI (DCE-MRI, see below).

Participants take BAY 43-9006 by mouth twice a day, morning and evening. On the first and 15th days of treatment, patients are admitted to the hospital for pharmacokinetic studies; that is, a test of how the body handles the drug. For the test, blood is collected at intervals (at 15 minutes, 30 minutes, and 1, 2, 4, 6, 8, 12 and 24 hours after ingestion) to determine the drug's level in the bloodstream. Treatment with BAY 43-9006 continues until the study doctor determines that the medication is not beneficial or the patient wishes to withdraw from the study.

In addition to drug therapy, patients undergo the following tests and procedures:

* Physical examination every 4 weeks
* Blood pressure checks once a week during the first 4 weeks
* Blood tests every week
* CT scans or other imaging tests, such as ultrasound or MRI, every 8 weeks to evaluate the tumor's response to treatment. CT is an x-ray test that provides detailed pictures of the inside of the body. It can be done from different angles, providing a 3-dimensional picture of the part of the body being studied and allowing the doctor to see the location, nature, and extent of disease. MRI uses a powerful magnet and radio waves instead of x-rays to produce accurate, detailed pictures of organs and tissues.
* PET-CT approximately every 8 weeks to look at how different parts of the body take up and use glucose (a sugar nutrient). Because rapidly growing cells, such as tumors, use more sugar than normal cells do, this test can be used to detect cancer. For the test, the patient is given an injection of a sugar solution in which a radioactive tracer has been attached to the sugar molecule. A special camera detects the radiation emitted by the solution, and the resulting images show how much sugar is being used in various parts of the body. PET-CT uses the PET scan in combination with standard CT in a machine that does both tests.
* DCE-MRI after 2 weeks of treatment. This test uses MRI with a special non-radioactive dye to examine blood flow in a certain part of the body.
* Tumor biopsy (optional) after 2 weeks of treatment. A biopsy is the surgical removal of a small piece of tissue. The tumor biopsy is done either using a small bore needle under CT guidance or by direct visualization using a laparoscope/thoracoscope. For the needle biopsy, a needle is inserted through the skin and guided by CT into the tumor mass. For the laparoscopy/thoracoscopy, the patient is sedated or asleep and small lighted tubes are inserted into small holes made in the skin. The tumor is located and tissue withdrawn.

Despite advances in systemic chemotherapy, patients with stage IV NSCLC will die from their disease. The median survival of all patients is 8-16 months, with a one year-survival rate of 33%. Chemotherapy is the mainstay of treatment of advanced disease. Based on available data from randomized trials, current treatment recommendations are to treat with one of several effective cisplatin-doublets which have resulted in median survival of 16 to 18 months. Second line chemotherapy is able to improve outcome in patients who have had prior cisplatin therapy. Although these important milestones represent improvements in the care of patients with metastatic NSCLC, outcome has not been able to be further improved by substituting one active drug for another in a platinum-based doublet, treating patients with more than four cycles of chemotherapy or by using cisplatin-based triplets. It is clear that if we are to improve outcome of NSCLC patients, we will need to develop drugs with novel mechanisms of action that perhaps will inhibit major cellular signaling pathways affecting survival, proliferation and angiogenesis. One new compound, BAY 43-9006, was designed to inhibit Raf and is also known to inhibit other kinases including VEGFR2, VEGFR3, PDGFR-beta, Flt3, c-KIT, and p38(1). BAY 43-9006 has shown in vitro activity against NSCLC cell lines NCI-H460 and A549 with tumor growth inhibition of 27% to 68%. In addition, BAY 43-9006 has shown activity in the H460 NSCLC xenograft model. In NSCLC, the proliferation signaling of the Ras/Raf/MEK/ERK pathway is increased due to the frequent (30%) presence of K-ras mutations in the tumor. Mutations in K-ras have been associated with malignant transformation of normal epithelium and constitutive activation of p21 and its downstream effects on cellular proliferation and inhibition of apoptosis. Clinical observations have shown that tumors with K-ras mutations tended to be smaller but more poorly differentiated, and associated with a significantly worse three-year mortality rate. As mentioned above, other pathways significant to the malignant potential of NSCLC, particularly those involved in angiogenesis, may also be affected by BAY 43-9006. The in vitro and in vivo data support the clinical investigation of BAY 43-9006 as an inhibitor of the Ras/Raf/MEK/ERK downstream proliferation effects. The goal of this phase II trial is to determinate if BAY 43-9006 is active in NSCLC, and to measure the BAY 43-9006 biological effects on the Ras/Raf/MEK/ERK pathway. To achieve these goals, patients with relapsed or recurrent NSCLC will be given BAY 43-9006 (four weeks cycle of 400mg PO BID). A series of correlative studies will be done during treatment to measure biological and clinical effects of BAY 43-9006. These studies will include analyses of tissue and blood samples as well as correlative imaging studies.

BAY 43-9006 (Sorafenib) to Treat Relapsed Non-Small Cell Lung Cancer

Phase II Study of Bay 43-9006 (Sorafenib) With Evaluation of RAS Signal Pathway in Patients With Relapsed Non-Small Cell Lung Cancer

Percentage of participants with response rate = CR + PR. Response will be evaluated by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR (complete response) is the disappearance of all target lesions; PR (partial response) is a 30% decrease in the sum of the longest diameter of target lesions; PD (progressive disease) is a 20% increase in the sum of the longest diameter of target lesions; and SD (stable disease) are small changes that do not meet the above criteria. Please see the Protocol Link module for additional information about RECIST if desired.

Time between the first day of treatment to the day of disease progression. Progressive disease is at least a 20% increase in the sum of the longest diameter of target lesions.

Appearance of one or more new lesions and/or unequivocal progressions of existing non-target lesions.

Here are the total number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Time between the first day of treatment to the days of death.

All patients will be genotyped for CYP3A4/5 and 5 polymorphisms.

Difference in placental derived growth factor (PLGF) between day 28 and day 0 of \< 11 pg/ml vs. \> 12 pg/ml.

Serial plasma samples were collected from all patients and cytokine levels were measured. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).

Mutational analysis of these genes was performed on paraffin-imbedded tissue blocks from prior pathologic specimens. Disease control rate was correlated with KRAS mutational status. Disease control rate was defined as complete remission (CR) + partial remission (PR)+ stable disease (SD).

Serum plasma is collected at the beginning of each cycle during the course of the study and analyzed by the enzyme-linked immunosorbent assay (ELISA).

DCE-MRI was used to evaluate changes (e.g. decrease/increase in Ve, Ktrans, Kep value) in vascularity and quality of index lesions to provide early indication of treatment effect before changes in size can be perceived on CT. Changes were reflected in a decrease/increase of Ve, Ktrans, or Kep (Kep, Ve, Ktrans measurements at day 0, day 14 and the difference between the day 14 and the day 0 measurements (day 14-day 0).

Immunohistochemical analysis performed by using state specific antibodies against Raf, methyl ethyl ketone (MEK), extracellular-signal regulated kinase (ERK), and two downstream substrates of ERK, E twenty-six (ETS)-like transcription factor 1 (ELK-1) and p90Ribosomal S6 kinase (p90RSK).

Serial plasma samples were collected from all patients at pretreatment (baseline - day 0), and on days 14, 28, and 54. The concentrations of the cytokines were determined with recombinant standards and expressed as picograms per milliliter (pg/ml).

Extracted DNA was subjected to an initial PCR using a single primer set encompassing codom V600. Pyrosequencing was carried out on a Qiagen PyroMaark Q24 system.

Pharmacoproteomic modulation targets (AKT, p-AKT, ERK 1/2, MEK, Cyclin D, p-ERK 1/2, p-MEK, pMEK, eNOA, p-eNOA, Cleaved PARP, PDGFRbeta, p-PDGFRbeta,Cyclin D, CD31, PARP. Caspase 9, Caspase 3, Cleaved Caspase-9 Cleaved Caspase 3)

Secondary pharmacoproteomic modulation targets (mTOR, EGFR, Src, NFkB, STAT1, TGFa, p38, Jak 1, lkB, IGFR, p-mTOR, p-EGFR, p-Src, p-NFkB, p-STAT1, Phospho-p38, p-Jak1, p-lkB,Pyk2, p-Pyk2, VEGFR-2, GSK3beta, p-GSK3beta, p-bad, p-Bcl-2, PCNA, Fos, Raf, CREB, Rho, avbeta3complex, Bad, CD34, VEGFR-1, bfGF, vWF, Factor VIII, Annexin V, Bcl-2).

National Cancer Institute (NCI)

Giuseppe Giaccone, M.D./National Cancer Institute

Age, Categorical

Age Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Giuseppe Giaccone, M.D., PH.D.

Response Rate

Progression Free Survival

The Number of Participants With Adverse Events

Overall Survival

The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to be more important.

Percent of Participants With Genotyping of CYP3A4/5 and 5 Polymorphisms

PLGF ,< 11 pg/ml

PLGF > 12 pg/ml

Overall Survival Reported Separately for Participants With a Change in PLGF Below 11 pg/ml and Above 12 pg/ml

VEGF

sVEGFRI

PLGF

bFGF

Cytokine Levels

DCR observed in KRAS mutant participants

DCR observed in KRAS wild-type participants

DCR observed in EGFR mutant participants

DCR observed in EGFR wild-type participants

11/34 KRAS positive; 23/34 KRAS negative 5/23 EGFR positive; 18/23 EGFR negative

Correlation of Response to Treatment With KRAS Mutational Status

Overall survival for bFGF day 0<6 pg/ml

Overall survival for bFGF day 0>6 pg/ml

14 patients with day 28 FGF \>6 and 14 patients with FGF \<6.

Overall Survival Associated With Basic Fibroblast Growth Factor (bFGF)

Progression free survival for bFGF day 28<6 pg/ml

Progression free survival for bFGF day 28>6 pg/ml

Progression Free Survival Associated With Basic Fibroblast Growth Factor (bFGF)

percentage of pts with an increase in Ktrans orKep

percentage of pts with an decrease in Ktrans orKep

Percentage of pts with an increase or decrease-Ve

Percentage of Participants With an Increase or Decrease in the Reverse Contrast Transfer Rate (Kep), Forward Contrast Transfer Rate (Ktrans), and Extravascular Fraction (Ve) With the Dynamic Contrast Enhanced Magnetic Resonance Imaging (DCE-MRI)

The analysis for this outcome measure was not performed. Endpoint lost interest when mutation analysis was felt to br more important.

Percent of Participants Who Had Immunohistochemical Analysis Performed for Raf, MEK, ERK, ERK-1 and p90RSK,ERK, E Twenty-six (ETS)-Like Transcription Factor 1 (ELK-1) and p90Ribosomal S6 Kinase (p90RSK).

Percent of Participants Who Had Cytokine Profiling for IL-6 and IL-8

Percentage of Participants With BRAF Mutations

Percent of Pts With Primary Pharmacoproteomic Modulation Targets

Secondary Pharmacoproteomic Modulation Targets

Overall Study

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Recurrence

Glioblastoma

Glioma

Brain Neoplasms

Astrocytoma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antirheumatic Agents

Immunomodulating Agents

Interleukin-4

Adjuvants, Immunologic

Immunologic Factors

Single infusion of MDNA55 via convection enhanced delivery (CED).\*

\*Subjects may be eligible to receive a second administration of MDNA55.

MDNA55 is an engineered circularly permuted interleukin-4 (cpIL-4) genetically fused to the catalytic domain of the pseudomonas exotoxin A (PE).

MDNA55

This is a single-arm, open-label, multicenter study in approximately 52 adults with primary (de novo) GB that has recurred or progressed (first or second recurrence, including this recurrence) after treatment(s) including surgery and radiotherapy with or without chemotherapy and following discontinuation of any previous standard or investigational lines of therapy.

The study drug, MDNA55, is a fusion protein comprising a genetically engineered Interleukin-4 (IL-4) linked to a modified version of the Pseudomonas aeruginosa exotoxin A (PE). MDNA55 binds to the IL-4 receptor (IL4R), over-expressed by cancer cells and non-malignant immunosuppressive cells of the tumor microenvironment (TME), and delivers a potent cell-killing agent, PE.

The study will be conducted at up to 10 clinical sites following institutional review board approval and completed informed consent.

Subjects that meet the study eligibility criteria will undergo surgery associated with study drug administration. MDNA55 will be administered locally by convection-enhanced delivery (CED).

Post-treatment follow-up assessment of safety and efficacy will be performed monthly for the first 6 months and bimonthly thereafter for approximately 1 year after study drug administrations. Subjects will continued to be followed for survival and post-study treatment(s) of GB after study completion or withdrawal.

Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma

An Open-Label Non-Randomized, Multi-Center Phase-2 Study of Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma

Number of Subjects with Serious adverse events with Frequency \>=5%

Incidence of Treatment-Emergent adverse events

Systemic exposure to MDNA55 is not expected following intratumoral infusion and circulating MDNA55 has not been detected in previous clinical studies. To continue to evaluate the potential of systemic exposure, plasma collected at screening (baseline), within 1 hour following infusion end time, \~3 hours following completion of infusion and then (after the \~3 hour sample collection) every 6 hours ± 2 hours until 24 hours and at Day 14. PK data will be presented for the PK population in listing format by subject and sample collection time point. PK parameters would only be analyzed if MDNA55 levels above LLOQ (0.37 ng/mL) were detected.

Number of participants that were ADA Positive and had Neutralizing Antibody

Primary endpoint analysis was based on the ITT population. The null hypothesis was mOS of 8.0 months, based on a clinically-weighted average of published studies of FDA-approved therapies versus the alternative hypothesis of 11.5 months.

ORR, determined by independent central review (per RANO-based criteria) Complete Response - Disappearance of all enhancing measurable and non-measurable disease sustained for at least 4 weeks.

Partial Response - ≥50% decrease in sum of products of perpendicular diameters or ≥65% decrease in total volume of all measurable enhancing lesions compared with baseline, sustained for at least 4 weeks Progressive Disease - At least two sequential scans separated by at ≥4 weeks both exhibiting ≥25% increase in sum of products of perpendicular diameters or ≥40% increase in total volume of enhancing lesions.

Stable Disease - Does not qualify for CR, PR, or PD as defined above

PFS, time from treatment until disease progression (per RANO-based criteria) or death Progressive Disease per RANO - At least two sequential scans separated by at ≥4 weeks both exhibiting ≥25% increase in sum of products of perpendicular diameters or ≥40% increase in total volume of enhancing lesions

Medicenna Therapeutics, Inc.

All patients were included in the in the ITT / Safety Population (N=47) for "MDNA55 (Overall)"; there is one patient that underwent catheter placement but did not receive the study drug; the infusion did not proceed due to catheter misplacement. Therefore, this participant is not included in the individual MDNA55 infusion arms (N=46)

Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. range 1.5 to 9.0 mcg/mL; total dose range 18 to 240 mcg

MDNA55 (Overall)

Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 1.5 mcg/mL

MDNA55 (1.5 mcg/mL)

Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 3.0 mcg/mL

MDNA55 (3.0 mcg/mL)

Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 6.0 mcg/mL

MDNA55 (6.0 mcg/mL)

Single infusion of MDNA55 administered via Convection Enhanced Delivery (CED) Dose conc. 9.0 mcg/mL

MDNA55 (9.0 mcg/mL)

Subjects received a single infusion of MDNA55 (via convection enhanced delivery) at concentrations ranging from 1.5 to 9.0 μg/mL and volumes ranging from 12 to 66 mL (total dose between 18 to 240 mcg)

Age (years)

Age, Customized

American Indian or Alaska Native

Asian

Black or African American

Native Hawaiian or Other Pacific Islander

White

Other

Race/Ethnicity, Customized

Ethnicity

Karnofsky Performance Score (KPS)

o6-methylguanine-DNA-methyltransferase (MGMT) Status

Steroid Use

Biopsy

Diagnostic method of Glioblastoma

Initial Surgery - Total Resection

Initial Surgery - Partial Resection

Initial Surgery - Other

Additional Surgery - Resection

Additional Surgery - Debulking

Additional Surgery - Other

Radiotherapy

Temozolomide

Other Chemotherapy

Investigational

Prior Glioblastoma treatment

Initial diagnosis to 1st relapse

Max tumor diameter at initial diagnosis

1st relapse

2nd relapse

Number of prior relapse

Tumor volume at baseline

Maximum tumor diameter at baseline

Lymphocyte Count

Intent-to-Treat and Safety: ITT and Safety populations were identical and consisted of all subjects who signed an informed consent form and received any amount of study drug.

Rosemina Merchant - Chief Development Officer

All subjects enrolled, received any amount of study drug

MDNA55 (ITT Analysis)

In support of the primary efficacy analysis, evaluation of the primary endpoint was also conducted on the PP population.

MDNA55 (PP Analysis)

Primary endpoint analysis was based on the ITT population. The null hypothesis was mOS of 8.0 months, based on a clinically-weighted average of published studies of FDA-approved therapies.

ITT/Safety population: all subjects who signed an informed consent form and received any amount of study drug.

Per-Protocol Population: all subjects in the ITT Population who had no major protocol violation during the study.

Primary efficacy analysis was not performed for individual dose concentrations.

Overall Survival (OS)

Single infusion of MDNA55 via convection enhanced delivery (CED).\*

\*Subjects may be eligible to receive a second administration of MDNA55.

MDNA55: MDNA55 is an engineered circularly permuted interleukin-4 (cpIL-4) genetically fused to the catalytic domain of the pseudomonas exotoxin A (PE).

Modified Intent-to-Treat Population (mITT): mITT population was used for secondary response analyses and consisted of all subjects who received any amount of study drug, had adequate imaging (at least 1 post-treatment scan), and had sufficient clinical data for ORR analysis.

Objective Response Rate (ORR)

Progression Free Survival (PFS)

Single infusion of MDNA55 via convection enhanced delivery (CED).

MDNA55: MDNA55 is an engineered circularly permuted interleukin-4 (cpIL-4) genetically fused to the catalytic domain of the pseudomonas exotoxin A (PE).

Number of Subjects With Serious Adverse Events

Treatment Emergent Adverse Events

Pharmacokinetic (PK) Population: Subjects who received the highest concentrations (6 μg/mL and 9 μg/mL) were analysed first. If all results were shown to be below lower limit of quantitation (LLOQ) of 0.37 ng/mL, consistent with historical data showing no evidence of systemic exposure with MDNA55, then no further subjects were to be analyzed. All subjects analyzed had levels of MDNA55 that were below lower limit of quantitation (LLOQ) of 0.37 ng/mL

Level of MDNA55 in Peripheral Plasma

ADA positive

Neutralizing Antibody (NAb)

Anti-Drug-Antibody (ADA) Population: ADA population included all subjects who received any dose of study drug and had a pre-treatment baseline blood sample and at least one post-treatment blood sample available for determination of ADA. Neutralizing antibody (NAb) titers were assessed in the ADA population as appropriate and applicable.

ADA Titer / Neutralizing Antibody Analysis

Subjects received a single infusion of MDNA55 (via convection enhanced delivery) at concentrations ranging from 1.5 to 9.0 μg/mL. Total dose administered did not exceed 240 μg (the established maximum tolerated dose \[MTD\]).

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Tailored letter and booklet, enhanced family communication and support brochure

Targeted

Enhanced Tailored

Maria C. Katapodi, PhD

The University of Michigan (UM) Schools of Nursing, Public Health, and Medicine, the Michigan Department of Community Health (MDCH) and the Michigan Cancer Consortium (MCC) are conducting a multidisciplinary academic/practice three-year project to increase appropriate breast cancer screening for young breast cancer survivors and their cancer-free, female relatives at greatest risk for breast cancer. The aims of this project are to: 1) identify and survey 3000 breast cancer survivors reported to the Michigan Cancer Surveillance Program who were diagnosed between the ages of 20-45 years regarding their breast cancer screening utilization; 2) identify and survey the survivors' female relatives regarding their breast cancer screening utilization; and 3) implement two versions (targeted vs. enhanced tailored) of an evidence-based intervention recommended by the Guide to Community Preventive Services to increase breast cancer screening. A follow-up survey will assess the effectiveness of each intervention on a) breast cancer screening utilization; b) perceived barriers and facilitators to screening; c) self-efficacy in utilizing screening services; d) family support related to screening; e) knowledge of the genetics of breast cancer and personal risk factors; and f) satisfaction with the intervention.

The University of Michigan (UM) Schools of Nursing, Public Health, and Medicine, the Michigan Department of Community Health (MDCH) and the Michigan Cancer Consortium (MCC) propose a multidisciplinary academic/practice three-year project to increase appropriate breast cancer screening utilization for young breast cancer survivors (YBCS), and their cancer-free, female relatives at greatest risk for breast cancer (high-risk relatives). The aims of this project are to: 1) identify and survey 3000 breast cancer survivors reported to the Michigan Cancer Surveillance Program who were diagnosed between the ages of 25-45 years regarding their breast cancer screening utilization; 2) identify and survey YBCS' high-risk relatives regarding their breast cancer screening utilization; and 3) implement two versions (targeted vs. enhanced tailored) of an evidence-based intervention recommended by the Guide to Community Preventive Services to increase breast cancer screening. Aim 1, will be accomplished in year 1 by MDCH, UM and MCSP. Following approval by appropriate review boards (MDCH, UM, and MCSP), reporting facilities and physicians of record, 3000 YBCS will be mailed a request to participate in the project and a baseline survey. The baseline survey will obtain information on the YBCS's: a) willingness to participate; b) current breast cancer screening utilization; c) perceived barriers and facilitators to screening and other outcomes related to breast cancer screening; d) identification of high-risk relatives to participate in the study and interest in serving as an advocate for their high-risk relatives to participate. Aim 2, will be accomplished in year 2 by the UM and MDCH. Based on the information provided by YBCS, the MDCH will identify up to two high-risk relatives per YBCS. UM and MDCH will mail YBCS who agree to participate in the study baseline surveys to distribute to their selected high-risk relatives. The baseline survey to high-risk relatives will obtain information on their: a) willingness to participate in the project; b) current breast cancer screening utilization; and c) perceived barriers and facilitators to screening and other outcomes related to breast cancer screening. Aim 3, will be accomplished by UM and MDCH. YBCS and their high-risk relatives will be randomized (as a family unit) to receive two versions of a small media, evidence-based intervention aiming to increase appropriate utilization of breast cancer screening services and other outcomes. In year 2-3, 9 months after YBCS and high-risk female relatives receive the intervention, UM will mail a follow-up survey to YBCS and their high-risk relatives to evaluate the effectiveness of each intervention version on: a) breast cancer screening utilization; b) perceived barriers and facilitators to screening; c) self-efficacy in utilizing screening services; d) family support related to screening; e) knowledge of the genetics of breast cancer and personal risk factors; and f) satisfaction with the intervention. The State of Michigan is considered a national leader in cancer prevention, control, and public health genomics. Key partners have significant prior experience in conducting studies with cancer survivors and their high-risk relatives. This project would greatly enhance state efforts in cancer prevention and control.

Interventions to Increase Screening by Breast Cancer Survivors and Their High Risk Female Relatives

Interventions to Increase Screening Utilization by Breast Cancer Survivors and Their High Risk Female Relatives: Using Cancer Surveillance and the Michigan Genomics Academic-Practice Partnership

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
BAY 43-9006 (Sorafenib) to Treat Relapsed Non-Small Cell Lung Cancer	NCT00098254	Non-Small-Cell ...	BAY 43-9006 (So...	18 Years -	National Institutes of Health Clinical Center (CC)
Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma	NCT02858895	Glioblastoma Grade IV Astroc... Glioblastoma Mu... Grade IV Glioma	MDNA55	18 Years -	Medicenna Therapeutics, Inc.
Interventions to Increase Screening by Breast Cancer Survivors and Their High Risk Female Relatives	NCT01612338	Breast Cancer Breast Cancer i... Breast Cancer i...	Targeted Enhanced Tailor...	20 Years - 64 Years	University of Michigan
Safety and Efficacy Study of ALT-801 to Treat Progressive Metastatic Malignancies	NCT00496860	Progressive Met...	ALT-801	18 Years -	Altor BioScience
Interventions to Increase Screening by Breast Cancer Survivors and Their High Risk Female Relatives	NCT01612338	Breast Cancer Breast Cancer i... Breast Cancer i...	Targeted Enhanced Tailor...	20 Years - 64 Years	University of Michigan
Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma	NCT02858895	Glioblastoma Grade IV Astroc... Glioblastoma Mu... Grade IV Glioma	MDNA55	18 Years -	Medicenna Therapeutics, Inc.
QUILT-2.008: Study of ALT-801 With Cisplatin in Patients With Metastatic Melanoma	NCT01029873	Metastatic Mela...	Cisplatin ALT-801	18 Years -	Altor BioScience
Interventions to Increase Screening by Breast Cancer Survivors and Their High Risk Female Relatives	NCT01612338	Breast Cancer Breast Cancer i... Breast Cancer i...	Targeted Enhanced Tailor...	20 Years - 64 Years	University of Michigan
ATN-161 in Advanced Renal Cell Cancer	NCT00131651	Carcinoma, Rena...	ATN-161	18 Years -	Attenuon

Spots Global Cancer Trial Database for targeted

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

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