Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Melanoma, Cutaneous Malignant

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patients receive indocyanine green and fluorescein sodium injection IV and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy.

Diagnostic Microscopy

Fluorescein Sodium Injection

Laboratory Biomarker Analysis

Undergo standard of care sentinel node biopsy

Sentinel Lymph Node Biopsy

Joseph Skitzki

This pilot clinical trial studies intravital microscopy in identifying tumor vessels in patients with stage IB-IIIC melanoma undergoing sentinel lymph node biopsy. By examining sentinel lymph nodes through intravital microscopy before they are removed, doctors may learn specific information regarding how melanoma may spread to lymph nodes and other sites of the body.

PRIMARY OBJECTIVES:

I. To determine the feasibility of intravital microscopy in characterizing the microvasculature of the sentinel lymph node (SLN) in melanoma patients requiring SLN biopsy.

SECONDARY OBJECTIVES:

I. To identify vascular blood flow parameters and flow kinetics associated with the sentinel lymph node vasculature and define the utility of using commonly used fluorescent agents during human intravital microscopy and correlate with clinical outcomes (time to recurrence, survival), as a potential basis for a novel prognostic tool and/or microstaging technique.

TERTIARY OBJECTIVES:

I. To determine the relationship between live microscopically-recorded images and pathology slides in terms of vessel density and vessel diameter.

OUTLINE:

Patients receive indocyanine green and fluorescein sodium injection intravenously (IV) and then undergo intravital microscopic observation over 15-20 minutes during standard of care sentinel node biopsy.

After completion of study treatment, patients are followed up at 3 weeks and then every 6 months for 5 years or every 3 months for 2 years and every 6 months for another 2 years.

Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy

Intravital Microscopy (IVM) During Sentinel Lymph Node (SLN) Biopsy for Melanoma

The relationship between the live microscopically-recorded images and the pathology slides in terms of vessel density and vessel diameter will be determined. Correlations between microscopic observations (vessel diameter, density, blood flow velocity, vessel hierarchy tissue penetration of fluorescein/indocyanine green) with pathologic node positivity and clinical outcomes (time to recurrence, survival) will be analyzed.

The visualization method will be deemed successful in patients with tumor vessel identification, measurement of tumor vessel diameters, determining vessel density, and visualizing fluorescein/indocyanine green within the tumor vessels.

Sample sentinel lymph node characteristics obtained from the intervention will be characterized using descriptive statistics (means, medians) and 95% confidence intervals.

Assessed using Kaplan Meier and Proportional Hazards methods. Collected through routine follow-up processes.

Assessed using Logistic Regression. Collected through routine follow-up processes.

Roswell Park Cancer Institute

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Interferons

Interferon-alpha

Interferon alpha-2

Antiviral Agents

Immunologic Factors

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b

Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

laboratory biomarker analysis

William Carson, MD

This pilot clinical trial studies recombinant interferon alfa-2b in treating patients with melanoma. Recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma

PRIMARY OBJECTIVES:

I. To determine whether selection of the optimal IFN-alpha-2b (recombinant interferon alfa-2b) dose can be made using signal transduction data.

SECONDARY OBJECTIVES:

I. To determine the tolerability of adjuvant IFN-alpha-2b administered at an optimized dose in terms of the toxicities that are observed and the ability of patients to receive a full year of therapy.

II. The transcription of a panel of IFN-alpha-induced genes previously identified by microarray analysis will be determined by Real-Time reverse transcriptase-polymerase chain reaction (RT PCR) in order that the correlation between signal transducer and activator of transcription 1 (STAT1) phosphorylation and IFN-alpha gene regulation can be evaluated.

III. Microarray analysis of patient peripheral blood mononuclear cells (PBMCs) will be used to evaluate the effect of dose-reduction on IFN-alpha gene expression.

IV. In order to define the clinical role of tumor sensitivity to IFN-alpha, patient tumor biopsies taken prior to the administration of IFN-alpha will be systematically evaluated for cellular levels of janus kinase (Jak)-STAT signaling intermediates.

OUTLINE:

Patients receive recombinant interferon alfa-2b subcutaneously (SC) thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3-6 months for 2 years.

Recombinant Interferon Alfa-2b in Treating Patients With Melanoma

Pilot Study of IFN-alpha-2b Dose Reduction With Dose Optimization

Mean and 95% confidence interval will be summarized for phospho-STAT1 at a lower dose and the standard dose. The phospho-STAT1 will also be compared between the dose levels.

Determine the tolerability of adjuvant IFN-α-2b administered at an optimized dose in terms of the toxicities that are observed and the ability of patients to receive a full year of therapy.

Levels of p-STAT1 in PBMCs were analyzed just prior to IFN-a-2b administration to determine levels that remained stable or increased over the course of dose reduction.

Evaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 10MU/m2

Evaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 4MU/m2

Evaluated using microarray analysis of patient PBMCs. Compared between doses using the Wilcoxon signed rank test.

Define the clinical role of tumor sensitivity to IFN-α, patient tumor biopsies taken prior to the administration of IFN-α will be systematically evaluated for cellular levels of Jak-STAT signaling intermediates.

Schering-Plough

William Carson

Principal Investigator

Patients receive recombinant interferon alfa-2b SC thrice weekly. Treatment continues for 11 months in the absence of disease progression or unacceptable toxicity.

recombinant interferon alfa-2b: Given SC

laboratory biomarker analysis: Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.

Treatment (Interferon Therapy)

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Dose I (10 MU/m2)

Dose II (4 MU/m2)

Level of Activated STAT1(Phospho-STAT1)

Number of Patients With Adverse Events

Percentage of Patients With Correlation Between STAT1 Phosphorylation and Interferon Alfa Gene Regulation

SOCS1-1 hour post 10MU-

OAS1-1 hour post 10MU-

CXCL10-1 hour post 10MU

CD69-1 hour post 10MU

Effect of Dose-reduction on Expression of Interferon Alfa Stimulated Genes

SOCS1-1 hour post 4MU

OAS1-1 hour post 4MU

CXCL10-1 hour post 4MU

CD69-1 hour post 4MU

Effect of Dose-reduction on Interferon Alfa Gene Expression

SOCS1- 4 hour post-10MU

OAS1-4 hour post -10MU

CXCL10-4 hour post- 10MU

CD69-4 hour post- 10MU

Effect of Dose-reduction on Interferon Alfa Gene Expression Through Marker CD69

SOCS1-4 hour post 4MU-

OAS1-4 hour post 4MU

CXCL10-4 hour post 4MU

CD69-4 hour post 4MU

Effect of Dose-reduction on Interferon Alfa Gene Expression at Dose Level 4MU

Data was not collected and analyzed for outcome measure

Clinical Role of Tumor Sensitivity to Recombinant Interferon Alfa-2b Using Cellular Levels of Jak-STAT Signaling Intermediates

Overall Study

Symptoms and General Pathology

Recurrence

Vaccines

Monatide (IMS 3015)

Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine with Montanide ISA 51 VG or Montanide ISA 51 SC on day 1 and between days 25-30. After 6 months, patients free of disease receive booster injections every 6 months for 3 years in the absence of unacceptable toxicity or disease progression.

gp100:209-217(210M) Peptide Vaccine

HPV 16 E7:12-20 Peptide Vaccine

Walter Urba

This pilot clinical trial studies booster vaccination in preventing disease recurrence in previously vaccinated patients with melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and prevent or delay the recurrence of cancer.

PRIMARY OBJECTIVES:

I. To assess the toxicity of booster vaccination with the gp100 (gp100:209-217(210M) peptide vaccine) and human papilloma virus (HPV) peptides in Montanide ISA 51 or Montanide ISA 51 VG administered \>= 12 months after the last immunization.

II. To measure the T-cell response to the modified gp100: 209-217 (210M) peptide and the unmodified native gp100 peptide following booster vaccination \>= 12 months after the last immunization.

III. To measure the T-cell response to the control human leukocyte antigen (HLA)-A2 restricted clusters of differentiation (CD)8 epitope of papilloma virus HPV16E7:12-20 following booster vaccination \>= 12 months after the last immunization.

IV. To perform detailed studies of the memory T cells persisting \>= 12 months after immunization.

OUTLINE:

Patients receive gp100:209-217(210M) peptide vaccine and HPV 16 E7:12-20 peptide vaccine with Montanide ISA 51 VG or Montanide ISA 51 subcutaneously (SC) on day 1 and between days 25-30. After 6 months, patients free of disease receive booster injections every 6 months for 3 years in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed up at 6 months, every 6 months for 5 years, and then annually thereafter.

Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery

A Pilot Study to Assess the Immunologic Response to Booster Vaccination With a Modified gp100 Melanoma Peptide (209-2M) Vaccine in Previously Vaccinated HLA-A2.1+ Patients With Melanoma

Characterized using three different in vitro assays. Fresh and cryopreserved peripheral blood mononuclear cells (PBMC) will be analyzed for gp100 peptide-specific CD8+ T cells using a fluorescinated, modified gp100, peptide-specific, A2-restricted tetramer binding assay and the interferon (IFN) gamma specific enzyme-linked immunosorbent spot (ELISPOT) and cytokine flow cytometry (CFC) assays.

Differences in immune parameters will be graphically depicted by means of density plots, frequency histograms, box and whisker-plots, dot-plots, trellis graphics (where appropriate) and other plots and graphs. Analyses of continuous variables will be performed first on the original frequency data. Goodness of fit statistics will be employed to determine whether assumptions underlying test statistics (e.g., normality) are satisfied. If assumptions for the test procedures are violated, then rank-transformed or arcsin-transformed data will be used. Probability tests will be two-sided.

National Cancer Institute (NCI)

Disease Progression

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

Propranolol

Adrenergic beta-Antagonists

Adrenergic Agents

Adrenergic Antagonists

Neurotransmitter Agents

113 patients will be enrolled in the placebo group with respect to randomization.

Placebo group will be prescribed placebo pills in the same packaging as propranolol treated group.

The frequency and duration of the treatment is the same as propranolol arm. The placebo group will have the same cardiology consultation as propranolol treated group to ensure the respect of blindness.

drug: 'Propranolol hydrochloride' 338 patients will be enrolled in the "Propranolol" Group and treated with propranolol.

The dosage will be determined by the cardiologist as the maximum tolerated dose to a maximum of 160mg/day.

One long acting pill a day until an evidence of disease progression or the end of the study.

This intervention apply to Propranolol group

Propranolol hydrochloride

We use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study.

Placebo pill

Frédérique-Anne Le Gal, MD/PhD

Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to an earlier detection of the primary tumour and a better prognosis, but melanoma remains an aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies compared groups of patients diagnosed with primary melanoma and treated with betablockers for another indication to patients who never received betablockers. In these three studies, the outcome of the disease is significantly better for people under betablocker treatment with a decreased rate of recurrence and a better 5 years survival rate. Here we want to investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for patients suffering from a primary melanoma with a high risk of recurrence.

Efficacy of Propranolol Treatment to Prevent Melanoma Progression

Phase 2 Prospective Study of the Efficacy of Propranolol on Malignant Melanoma Progression. A Randomized Placebo-controlled,Single Blind Trial

The efficacy of propranolol treatment will be tested in one interim analysis when the last patient enrolled have reached one year of follow up and one final analysis when the last patient enrolled have reached three years of follow up. The primary endpoint of the study will be the progression of the disease.

We will measure the efficacy of a propranolol treatment on the risk of progression of the disease.

We will investigate the microRNA profile in the serum of patients of both groups during the whole study to identify biomarkers specific for recurrence.

We investigate the impact of propranolol treatment on the 5 years survival.

University Hospital, Geneva

Associate Physician, PD, MD/PhD

Patients access ITW and complete each module over 30-40 minutes. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.

Patients receive usual care and are then offered ITW. All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.

Internet-Based Intervention

Questionnaire Administration

Survey Administration

Elliot Coups

This clinical trial studies how well an interactive tailored website works in promoting sun protection and skin self-check behaviors in patients with stage 0-III melanoma. An internet-based program may help individuals to perform skin self-checks and engage in sun protection behaviors.

PRIMARY OBJECTIVES:

I. To evaluate the impact of the interactive tailored website (ITW) versus usual care on skin self-examination (SSE) and sun protection behaviors among individuals diagnosed with melanoma.

SECONDARY OBJECTIVES:

I. To examine mediators of the impact of the intervention. The effects of the intervention on SSE and sun protection behaviors will be mediated by melanoma knowledge, self-efficacy for SSE and sun protection behaviors, perceived benefits of SSE and sun protection behaviors, perceived barriers to SSE and sun protection behaviors, and perceived controllability of melanoma.

TERTIARY OBJECTIVES:

I. To examine moderators of the impact of the intervention. To evaluate whether ITW effects are moderated by the following factors: time since diagnosis, disease stage, age, sex, income, education, Internet experience, distress about melanoma, worry about recurrence, and evaluation and usage of the ITW.

OUTLINE:

Phase I: Patients review draft website content materials in a semi-structured format and provide feedback via open- and closed-ended questions for the development, testing, and finalization of ITW.

Phase II: Patients are randomized into 1 of 2 arms.

ARM I: Patients access ITW and complete each module over 30-40 minutes.

ARM II: Patients receive usual care and are then offered ITW.

All patients in Phase II complete surveys over 20-40 minutes at 8, 24, and 48 weeks.

Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma

Internet Intervention for Sun Protection and Skin Self-check Behaviors

Level of distress (from 1 = not at all distressed to 10 = extremely distressed)

Mean rating of four questions regarding worry about melanoma recurrence

Mean rating of four questions regarding perceived risk of melanoma recurrence

Number of times indoor tanned in the past year

Whether a new or recurrent skin cancer was diagnosed

Ineligibility rate and reasons, recruitment rate and reasons for refusal, differences in sociodemographic factors between study decliners and those recruited, dropout rate and reasons.

Receipt of a physician skin examination and the reason for the visit

Perceived Internet Impact and Effectiveness Questionnaire was used. This 20-item survey was used to measure the degree to which MSS helped the participant learn how to be prepared to conduct SSE and engage in sun protection behaviors as well as feel in control of his/her health and feel less worried about melanoma. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent greater effectiveness of the program.

Number of visits to the website, the number of monthly skin self-checks completed, the number of updates to the sun-safe action plan, and starting/completing the remaining sections of the website (Introduction; Getting Ready to Do a Skin Self-Check; Practice Sun-Safe Behaviors).

Internet Evaluation and Perceived Utility Questionnaire and the Internet Adherence Questionnaire was used. This 15-item survey assessed the program characteristics, including usefulness, convenience, ease of use, worry about privacy, ease of navigation, and satisfaction with the program. A Likert scale was used for each question (1=not at all, 2=slightly, 3=somewhat, 4=mostly, 5=very). The scores from each question were averaged to compute the total scale score for each participant. The total scores for each participant were also averaged to find the overall average across MSS participants. Higher values represent higher scores in terms of utility and evaluation of the program.

Participants rated how often they engaged in four behaviors when outside on a sunny day: wearing sun screen with an Sun Protection Factor ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade. Items were rated on a five-point Likert scale (1=never, 2= rarely, 3= sometimes, 4= often, 5=always). In this case, higher values are associated with more protection behaviors. Subscales were averaged to compute the total index score.

Defined as thoroughly examining each area of the body during the most recent skin self-check in the last 2 months.

Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 4 months

Defined as thoroughly examining each area of the body during the most recent skin self-check in the past 6 months

Total number of SSEs performed (regardless of their thoroughness)

Total number of body areas examined during the most recent SSE in the last 2 months

Use of a mirror, having someone else help, or using a body mole map during the most recent SSE

Frequency (from 1 = never to 5 = always) of wearing sunscreen with an SPF ≥ 30, wearing a long-sleeved shirt, wearing a wide-brimmed hat, and staying in the shade

Frequency (from 1 = never to 5 = always) of wearing long pants

Frequency (from 1 = never to 5 = always) of wearing sunglasses

Frequency (from 1 = never to 5 = always) of spending time in the sun in order to get a tan

University of Virginia

Rutgers, The State University of New Jersey

Professor and Associate Director of Population Science

Adverse events were not monitored/assessed. There is no risk for participating in this study and, therefore, zero participants are at risk of facing an adverse event.

Of 485 enrolled individuals, 224 were randomized to MSS.

These individuals access MSS content and complete the three educational Cores. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.

mySmartSkin

Of the 485 enrolled individuals, 217 were randomized to the UC condition.

These participants received the usual clinical follow-up care. Individuals completed surveys at baseline, 8 weeks, 24 weeks and 48 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intravital Microscopy in Identifying Tumor Vessels in Patients With Stage IB-IIIC Melanoma Undergoing Sentinel Lymph Node Biopsy	NCT02857374	Stage IB Skin M... Stage IIA Skin ... Stage IIB Skin ... Stage IIC Skin ... Stage IIIA Skin... Stage IIIB Skin... Stage IIIC Skin...	Diagnostic Micr... Fluorescein Sod... Laboratory Biom... Sentinel Lymph ...	18 Years -	Roswell Park Cancer Institute
Recombinant Interferon Alfa-2b in Treating Patients With Melanoma	NCT01460875	Stage IA Skin M... Stage IB Skin M... Stage IIA Skin ... Stage IIB Skin ... Stage IIC Skin ... Stage IIIA Skin... Stage IIIB Skin... Stage IIIC Skin... Stage IV Skin M...	recombinant int... laboratory biom...	12 Years -	Ohio State University Comprehensive Cancer Center
Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery	NCT01989559	Recurrent Melan... Stage IA Skin M... Stage IB Skin M... Stage IIA Skin ... Stage IIB Skin ... Stage IIC Skin ... Stage IIIA Skin... Stage IIIB Skin... Stage IIIC Skin... Stage IV Skin M...	gp100:209-217(2... HPV 16 E7:12-20... Laboratory Biom...	-	National Cancer Institute (NCI)
Booster Vaccination in Preventing Disease Recurrence in Previously Vaccinated Patients With Melanoma That Has Been Removed By Surgery	NCT01989559	Recurrent Melan... Stage IA Skin M... Stage IB Skin M... Stage IIA Skin ... Stage IIB Skin ... Stage IIC Skin ... Stage IIIA Skin... Stage IIIB Skin... Stage IIIC Skin... Stage IV Skin M...	gp100:209-217(2... HPV 16 E7:12-20... Laboratory Biom...	-	National Cancer Institute (NCI)
Efficacy of Propranolol Treatment to Prevent Melanoma Progression	NCT01988831	Stages III Skin... Stages II Skin ... Stage IB Skin M...	Propranolol hyd... Placebo pill	18 Years -	University Hospital, Geneva
Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma	NCT03028948	Stage 0 Skin Me... Stage I Skin Me... Stage IA Skin M... Stage IB Skin M... Stage II Skin M... Stage IIA Skin ... Stage IIB Skin ... Stage IIC Skin ... Stage III Skin ... Stage IIIA Skin... Stage IIIB Skin... Stage IIIC Skin...	Internet-Based ... Questionnaire A... Survey Administ...	18 Years -	Rutgers, The State University of New Jersey

Spots Global Cancer Trial Database for stage ib skin melanoma