Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Musculoskeletal Diseases

Rare Diseases

Carcinoma

Nasopharyngeal Carcinoma

Paranasal Sinus Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Nose Neoplasms

Nose Diseases

Respiratory Tract Diseases

Paranasal Sinus Diseases

Respiratory Tract Neoplasms

Sinus Cancer

Herbal and Botanical

All Drugs and Chemicals

Eucalyptus

Clove

Patients undergo olfactory training by smelling 4 essential oils in vials (rose, lemon, clove, and eucalyptus) over 15 seconds each, twice daily for 12 weeks.

Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.

Physiologic Testing

Quality-of-Life Assessment

Sham Intervention

Therapeutic Procedure

rose essential oil

lemon essential oil

clove essential oil

eucalyptus essential oil

canola oil placebo

Zara Patel

This randomized phase I trial studies how well olfactory training works in improving sense of smell after radiation therapy in patients with paranasal sinus or nasopharyngeal cancer. Olfactory training may improve smell function after radiation therapy in patients with paranasal sinus or nasopharyngeal cancer.

PRIMARY OBJECTIVES:

I. To evaluate the effect of olfactory training on olfactory function in patients with paranasal sinus and nasopharyngeal carcinoma suffering from olfactory loss after radiation.

SECONDARY OBJECTIVES:

I. To evaluate the possible effect of olfactory training on quality of life in patients with paranasal sinus and nasopharyngeal carcinoma suffering from olfactory loss after radiation.

II. To study rate and severity of olfactory dysfunction after radiation therapy in patients with paranasal sinus or nasopharyngeal carcinoma.

III. To evaluate the possible preventive effect of olfactory training on olfactory dysfunction in patients with paranasal sinus and nasopharyngeal carcinoma who will undergo radiation therapy.

OUTLINE: Patients are randomized to 1 of 2 arms. Arm I: Patients undergo olfactory training by smelling 4 essential oils in vials (rose, lemon, clove, and eucalyptus) over 15 seconds each, twice daily for 12 weeks.

Arm II: Patients undergo sham training by smelling canola oil in 4 vials over 15 seconds each, twice daily for 12 weeks.

Olfactory Training in Improving Sense of Smell After Radiation Therapy in Patients With Paranasal Sinus or Nasopharyngeal Cancer

Olfactory Training For Post Radiation Olfactory Loss In Patients With Paranasal Sinus and Nasopharyngeal Carcinoma

T-test or Mann-Whitney U test, where appropriate, will be used for comparing continuous variables, and chi-squared test will be used for comparing categorical variables. Continuous UPSIT score will be summarized using the following statistics: number of subjects, arithmetic mean, standard deviation, median, first quartile, third quartile, minimum, and maximum values. The dependent variable UPSIT score will be either the percent change from baseline or change from baseline in the endpoint. Mixed model repeated measures (MMRM) analysis will be used and the model will included fixed effect terms

Within each subgroup of participants, change in QOD score after olfactory training will be calculated and compared between treatment and control group. Confidence interval (CI) 95% and P value \< 5% will be set as statistical parameters to define if noted difference is significant. Based on previous studies, a change of \>= 1/2 standard deviation of the pre-treatment score would be clinically significant.

T-test or Mann-Whitney U test, where appropriate, will be used for comparing continuous variables, and chi-squared test will be used for comparing categorical variables. Continuous UPSIT score will be summarized using the following statistics: number of subjects, arithmetic mean, standard deviation, median, first quartile, third quartile, minimum, and maximum values. Continuous UPSIT score will be summarized using the following statistics: number of subjects, arithmetic mean, standard deviation, median, first quartile, third quartile, minimum, and maximum values. These statistics will be shown

Stanford University

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Recurrence

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Undergo collection of tissue and blood samples

cytology specimen collection procedure

molecularly targeted therapy, MEK 162 therapy

MEK 162 therapy or molecularly targeted therapy

therapeutic procedure

laboratory biomarker analysis

quality-of-life assessment

Patricia LoRusso, D.O.

This phase II trial studies how well molecularly targeted therapy works in treating patients with melanoma that has spread to other parts of the body. Patients must have received or do not qualify for prior immunotherapy. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells with less harm to normal cells. Molecularly targeted therapy works by treating patients with substances that kill cancer cells by targeting key molecules involved in cancer cell growth.

PRIMARY OBJECTIVES:

I. To determine the difference in best overall response rate (BORR) between patients treated with MEK162 following personalized molecularly guided assignment vs. a historical BORR of 7% in this patient population.

SECONDARY OBJECTIVES:

I. To evaluate the safety of performing individualized drug therapy (including novel agents and commercially-available agents) in the context of a personalized medicine clinical trial.

II. To define the difference in progression free survival (PFS) between patients treated with MEK162 following personalized molecularly guided assignment vs. a historical PFS rate of 2 months in this patient population.

III. To continually assess data in real time so as to iteratively refine and standardize a set of statistical and informatics methodologies for matching treatments to the patient's tumor, based on the molecular profile.

OUTLINE:

Patients undergo collection of tissue and blood samples for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days.

Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic

Stand Up to Cancer Consortium Genomics-Enabled Medicine for Melanoma (G.E.M.M.): Using Molecularly-Guided Therapy for Patients With BRAF Wild-Type (BRAFwt) Metastatic Melanoma

The best overall response rate (BORR) was assessed up to 1 year.

A log rank test will be performed for the comparison between the two groups.

National Cancer Institute (NCI)

Yale University

Patients undergo collection of tissue and blood samples for DNA and RNA analysis via sequencing. Based on the results of the DNA and RNA analysis, patients receive molecularly targeted therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

cytology specimen collection procedure: Undergo collection of tissue and blood samples

MEK 162 therapy or molecularly targeted therapy: molecularly targeted therapy, MEK 162 therapy

therapeutic procedure

laboratory biomarker analysis: Correlative studies

quality-of-life assessment: Ancillary studies

Arm I (Molecularly Targeted Therapy)

30-39

40-49

50-59

60-69

70-79

80-89

Age, Customized

Sex: Female, Male

American Indian or Alaskan Native

Asian or Pacific Islander

Black, not of Hispanic Origin

Hispanic

White, not of Hispanic Origin

Other/

Race/Ethnicity, Customized

United States

Region of Enrollment

Because of the lack of clinical response, it was decided that enrollment should discontinue. Twenty patients who received MEK162 were evaluated for the primary outcome; secondary outcome was not evaluated.

Manuel Avedissian, M.D.

Progressive Disease

Stable Disease

Partial Response

Best Overall Response Rate (BORR)

Given the lack of response in this study and the decision to terminate it early, no data for PFS data were collected or analyzed. In addition, with the study amendment removing the second arm, this analysis would not have been possible to conduct.

Progression-Free Survival (PFS)

Overall Study

Heart and Blood Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Pleural Effusion, Malignant

Pleural Effusion

Pericardial Effusion

Thoracic Neoplasms

Lung Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Pleural Diseases

Pleural Neoplasms

Heart Diseases

Patients receive standard of care treatment based on the discretion of the treating physician.

Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.

targeted therapy

Hossein Borghaei

This randomized clinical trial studies how well genetic sequencing-informed targeted therapy works in treating patients with stage IIIB-IV non-small cell lung cancer. Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of tumor cells that may have less harm to normal cells. Genetic sequencing may help identify these specific types of tumor cells in patients with non-small cell lung cancer.

PRIMARY OBJECTIVES:

I. The three month progression free survival (PFS) of patients treated with targeted agents in the second line setting based on the tumor molecular signature as defined by CancerCode will be 40% vs 20% with standard cytotoxic chemotherapy.

SECONDARY OBJECTIVES:

I. Response rate (RR). II. Overall survival (OS). III. Proportion of Arm-B patients whose second line therapy is changed as a result of physician access to CancerCode-50 results.

IV. Concordance of variants identified when sequencing is performed on samples from the same patient collected at baseline and follow-up time points.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive standard of care therapy based on the discretion of the treating physician.

ARM B: Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 1 year, and then annually thereafter.

Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer

CancerCodeTM Informed, Molecularly Targeted Therapies in Non-small Cell Lung Cancer

The concordance of variants identified when sequencing will be performed on samples from the same patient collected at baseline and follow-up time points will also be measured.

The incidence of non-protocol testing of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.

The response rate of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.

The progression free survival of those patients in Arm A who undergo molecular testing (by any method) at the discretion of the treating physician will be estimated.

A chi-square test (one-sided; alpha = .1) will be used to assess the efficacy of treating patients with targeted agents based in the Cancer-Code-50 in the second line setting. For each patient "success" will be defined as being progression free for at least 3 months following initiation of second line therapy. Progression free survival times will be characterized separately by arm using the method of Kaplan and Meier.

The response rate (with 95% two-sided confidence intervals) will be computed separately by arm. One-sided chi-square or Fisher's exact tests (alpha = .1) will be used to evaluate differences in response rates between arms.

To assess the effect of sequencing on clinical practice and decision making the proportion of Arm B patients whose second line therapy is changed as a result of physician access to CancerCode-50 results will be computed. This comparison will be based on information provided by the treating physician before being exposed to the sequencing results, and information obtained from a from post-treatment chart review.

Fox Chase Cancer Center

There was only one patient enrolled and the study was closed before the patient started treatment.

Patients receive standard of care treatment based on the discretion of the treating physician.

therapeutic procedure: Receive standard of care treatment

laboratory biomarker analysis: Correlative studies

Arm A (Standard of Care Treatment)

Patients undergo collection of tissue and blood samples for analysis via sequencing. Upon disease progression following front-line treatment, patients receive specific targeted therapy based on the mutational status obtained during sequencing.

cytology specimen collection procedure: Undergo collection of tissue and blood samples

targeted therapy: Receive specific targeted therapy

laboratory biomarker analysis: Correlative studies

Arm B (Genetic Sequencing and Targeted Therapy)

Total

Age, Categorical

Age, Continuous

Dr. Hossein Borghaei

Progression Free Survival

Response Rate Defined by RECIST 1.1

Proportion of Arm B Patients Whose Second Line Therapy is Changed as a Result of Physician Access to CancerCode-50 Results

Concordance of Variants (Arm B)

Incidence of Non-protocol Testing (Arm A)

Response Rate Defined by RECIST 1.1 (Arm A)

Progression Free Survival (Arm A)

Patients undergo collection of tissue and blood samples for analysis via next generation sequencing. Patients receive standard of care therapy based on the discretion of the treating physician.

Patients undergo collection of tissue and blood samples for analysis via next generation sequencing. Based on the results of the next generation sequencing, patients receive target-directed therapy.

Anthony Olszanski

This randomized clinical trial studies how well next generation sequence target-directed therapy works in treating patients with cancer. Next generation sequencing is a test that screens for mutations to cancer related genes. Target-directed therapy is a type of treatment that uses drugs or other substances to identify and attack specific types of cancer cells that may have less harm to normal cells. Next generation sequencing may help identify these specific types of cancer cells.

PRIMARY OBJECTIVES:

I. Overall (composite) response rate (ORR).

SECONDARY OBJECTIVES:

I. 4-month progression free survival (PFS). II. Mutation rate. III. Adverse event rate/severity. IV. Overall survival.

TERTIARY OBJECTIVES:

I. Targeted agent rate. II. Available protocol rate. III. Protocol enrollment rate. IV. Disease site influence.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients undergo collection of tissue and blood samples for analysis via next generation sequencing. Patients receive standard of care therapy based on the discretion of the treating physician.

ARM B: Patients undergo collection of tissue and blood samples for analysis via next generation sequencing. Based on the results of the next generation sequencing, patients receive target-directed therapy.

After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.

Next Generation Sequence Target-Directed Therapy in Treating Patients With Cancer

A Prospective Randomized Trial Comparing the Effectiveness of Physician Discretion Guided Therapy Versus Physician Discretion Guided Plus Next-Generation Sequence Directed Therapy

The targeted agent rate will be estimated as the fraction of patients in arm B receiving target-directed therapy. 95% confidence intervals will be determined.

The available protocol rate will be estimated as the fraction of mutations for which a local protocol offers a potential therapeutic. 95% confidence intervals will be determined.

The protocol enrollment rate will be estimated as the fraction of patients in any ongoing trial who participate in this one.

Disease site influence will be characterized by the median OS and 4 month PFS for each disease site allocation.

The overall (composite) response rate will be defined by tumor response rate according to RECIST 1.1 or by tumor marker response for patients without measurable disease defined by RECIST 1.1. Tumor marker response will be quantified as a 50% reduction in the marker of interest, when compared to baseline, without any radiographic evidence of progressive disease.

The percentage of patients progression free and alive will be estimated using the method of Kaplan and Meier. PFS in control will be compared to those in the experimental arm using log-rank tests.

Mutation rate, defined as the percentage of patients with \>= 1 mutation identified will be estimated using the method of Pearson and Clopper as binomial proportions. 95% confidence intervals will be provided for these proportions.

The percentage of patients with "actionable" mutation rate will be estimated using the method of Pearson and Clopper as binomial proportions. 95% confidence intervals will be provided for these proportions.

The rate of adverse events will be estimated using the method of Pearson and Clopper as binomial proportions. 95% confidence intervals will be provided for these proportions. Adverse events will be tabulated according to severity.

OS will be estimated using the method of Kaplan and Meier. OS in control will be compared to those in the experimental arm using log-rank tests.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Olfactory Training in Improving Sense of Smell After Radiation Therapy in Patients With Paranasal Sinus or Nasopharyngeal Cancer	NCT03049358	Stage 0 Nasopha... Stage 0 Paranas... Stage I Nasopha... Stage I Paranas... Stage II Nasoph... Stage II Parana... Stage IIA Nasop... Stage IIB Nasop... Stage III Nasop... Stage III Paran... Stage IV Nasoph... Stage IV Parana... Stage IVA Nasop... Stage IVA Paran... Stage IVB Nasop... Stage IVB Paran... Stage IVC Nasop... Stage IVC Paran...	Physiologic Tes... Quality-of-Life... Sham Interventi... Therapeutic Pro... rose essential ... lemon essential... clove essential... eucalyptus esse... canola oil plac...	19 Years -	Stanford University
Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic	NCT02094872	Recurrent Melan... Stage IIIA Mela... Stage IIIB Mela... Stage IIIC Mela... Stage IV Melano...	cytology specim... MEK 162 therapy... therapeutic pro... laboratory biom... quality-of-life...	18 Years -	Yale University
Genetic Sequencing-Informed Targeted Therapy in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer	NCT02132884	Malignant Peric... Malignant Pleur... Recurrent Non-s... Stage IIIB Non-... Stage IV Non-sm...	cytology specim... therapeutic pro... targeted therap... laboratory biom...	-	Fox Chase Cancer Center
Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic	NCT02094872	Recurrent Melan... Stage IIIA Mela... Stage IIIB Mela... Stage IIIC Mela... Stage IV Melano...	cytology specim... MEK 162 therapy... therapeutic pro... laboratory biom... quality-of-life...	18 Years -	Yale University
Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic	NCT02094872	Recurrent Melan... Stage IIIA Mela... Stage IIIB Mela... Stage IIIC Mela... Stage IV Melano...	cytology specim... MEK 162 therapy... therapeutic pro... laboratory biom... quality-of-life...	18 Years -	Yale University
Next Generation Sequence Target-Directed Therapy in Treating Patients With Cancer	NCT02132845	Malignant Neopl...	cytology specim... targeted therap... therapeutic pro... laboratory biom...	19 Years -	Fox Chase Cancer Center

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