All Drugs and Chemicals

Vaccines

Immunomodulating Agents

Intradermal injection of ACIT-1 cellular immunotherapy, a total of 2 doses, 4 weeks apart of either 10e5, 10e6, 10e7 or 3x10e7 cells. For patients with pancreatic or haematological cancer. Treatment will run concurrently with standard chemotherapy.

Intradermal injection of ACIT-1 cellular immunotherapy, a total of 2 doses, 4 weeks apart of either 10e5, 10e6, 10e7 or 3x10e7 cells. For patients with other late stage cancers, not receiving any other standard treatment.

ACIT-1

Daniel H Palmer, MBChB PhD

This study evaluates four different doses of ACIT-1 for safety and for the ability to raise effective anti-cancer immune responses in patients with pancreatic and other cancers. Approximately half of the patients will have pancreatic cancer and the other half will have other cancers.

The immune system has an important role in helping prevent cancer by destroying early cancer cells. When cancer does develop antigen-specific immune (T) cells are still present in the blood but are either not responding or are not effective. Vaccines stimulate these T cells to respond and kill cancer cells.

ACIT-1 is designed to stimulate tumour antigen-specific T cells to respond and kill cancer cells.

Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer

A Phase I Clinical Study to Determine the Optimal Dose for the Safe Immune Restoration and Immune Response of Allogeneic Cell Immunotherapy (ACIT-1) in Adult Cancer Patients

Changes in tumour antigen specific immune responses in the blood compared to baseline

Toxicity based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.

Liverpool University Hospitals NHS Foundation Trust

The Clatterbridge Cancer Centre NHS Foundation Trust

University of Liverpool

Cancer Research UK

National Institute for Health Research, United Kingdom

Cancer Vaccines Charitable Trust

Cancer Vaccines Limited

Behaviors and Mental Disorders

All Conditions

Stress, Psychological

Patients will be required to participate in intervention activities and 5 data collection interviews. Interviews to complete both open-ended interviews and quantitative measures will take approximately 45 minutes. The actual administration of the intervention (viewing of video recordings) will take approximately 30 minutes with all sessions to occur over a 3 week period.

Family caregivers will be required to participate in intervention activities and 5 data collection interviews. Interviews to complete both open-ended interviews and quantitative measures will take approximately 45 minutes. The actual administration of the intervention (viewing of video recordings) will take approximately 30 minutes with all sessions to occur over a 3 week period.

The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. There will be 5 vignettes included in each session with each vignette edited to a real time of 3-4 minutes (each session is 30 minutes). Since the intervention is designed to be self-administered, there will be a video recorded introduction and instructions for use narrated by the PI. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn. The hymns included represent exemplars from the 5 themes prevalent in the PI's previous research

Faith-Based African American Cancer Survivorship Storytelling Intervention

Jill B Hamilton, PhD, RN

The purpose of this research study is to evaluate the feasibility and acceptability of an intervention (viewing of video recordings) designed to reduce psychological distress among African Americans during treatment for cancer. This knowledge will inform a larger test of an intervention.

This study addresses a need to integrate spirituality with cancer care as requested among African Americans. In the PI's research with African Americans, a dominant mental health promoting strategy used in response to a cancer diagnosis is the use of religious stories and songs. African Americans have a strong cultural history of relying on religious stories and songs to overcome oppression and mental suffering encountered in their lived experience. If successful, the findings from this preliminary study will contribute to the evidence that spirituality is important to cancer care and to achieving optimal patient outcomes among this medically underserved population. More importantly, the infusion of spirituality in cancer care has to potential to reduce the high levels of psychological distress experienced among African Americans and FCG's; to enable them to become more engaged in their cancer care and in supportive family relationships; and, ultimately to improve the overall quality of life for African American cancer patients and FCGs. The actual administration of the intervention (viewing of video recordings) will take approximately 30 minutes with all sessions to occur over a 3 week period. The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn.

Faith-Based African American Cancer Survivorship Storytelling

Faith-Based African American Cancer Survivorship Storytelling: A Culturally Relevant Intervention to Alleviate Psychological Stress

Psychological distress for patients and family caregivers (FCGs) will be measured with the Hospital Anxiety and Depression Scale (HADS).

Scoring for the Anxiety and Depression scale of the HADS is (0-21); Normal (0-7); Borderline Abnormal Case (8-10); and Abnormal Case (11-21). Higher score correlates with worse outcome.

Mutuality is measured with the scale "You, Your Family and Friends" that measures the degree of positive relationships among participants and their family and friends. This scale measures the degree to which the caregiver-care receiver relationship was characterized by love, shared values, shared pleasurable activities, and reciprocity. The adapted scale has 12-items with a 5-point response format. A mean of responses with a range of 0 to 5 will be reported. Higher scores are indicative of better outcomes, indicating engagement in positive supportive relationships with family and friends.

National Institute on Minority Health and Health Disparities (NIMHD)

Emory University

Professor

Patients will be required to participate in intervention activities and 5 data collection interviews. Interviews to complete both open-ended interviews and quantitative measures will take approximately 45 minutes. The actual administration of the intervention (viewing of video recordings) will take approximately 30 minutes with all sessions to occur over a 3 week period.

Faith-Based African American Cancer Survivorship Storytelling Intervention: The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. There will be 5 vignettes included in each session with each vignette edited to a real time of 3-4 minutes (each session is 30 minutes). Since the intervention is designed to be self-administered, there will be a video recorded introduction and instructions for use narrated by the PI. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn. The hymns included represent exemplars from the 5 themes prevalent in the PI's previous research

African American Cancer Patients

Family caregivers will be required to participate in intervention activities and 5 data collection interviews. Interviews to complete both open-ended interviews and quantitative measures will take approximately 45 minutes. The actual administration of the intervention (viewing of video recordings) will take approximately 30 minutes with all sessions to occur over a 3 week period.

Faith-Based African American Cancer Survivorship Storytelling Intervention: The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. There will be 5 vignettes included in each session with each vignette edited to a real time of 3-4 minutes (each session is 30 minutes). Since the intervention is designed to be self-administered, there will be a video recorded introduction and instructions for use narrated by the PI. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn. The hymns included represent exemplars from the 5 themes prevalent in the PI's previous research

Family Caregivers

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Jill Hamilton

Baseline

Week 3 post-intervention

African American Cancer Patients and Family Caregivers

Number of participants analyzed include participants that completed the Hospital Anxiety and Depression Scale (HADS) in the study sessions for each time point.

Hospital Anxiety and Depression Scale (HADS) Score

Number of participants analyzed include participants that completed the Supportive Family Relationships (Mutuality) Scale in the study sessions for each time point.

Supportive Family Relationships (Mutuality) Scale Score

Family Caregivers will be required to participate in intervention activities and 5 data collection interviews. Interviews to complete both open-ended interviews and quantitative measures will take approximately 45 minutes. The actual administration of the intervention (viewing of video recordings) will take approximately 30 minutes with all sessions to occur over a 3 week period.

Faith-Based African American Cancer Survivorship Storytelling Intervention: The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. There will be 5 vignettes included in each session with each vignette edited to a real time of 3-4 minutes (each session is 30 minutes). Since the intervention is designed to be self-administered, there will be a video recorded introduction and instructions for use narrated by the PI. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn. The hymns included represent exemplars from the 5 themes prevalent in the PI's previous research

Overall Study

Symptoms and General Pathology

Neoplasms

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Recurrence

Carcinoma

Breast Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Lung Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

Dermatologic Agents

Central Nervous System Depressants

Other Dietary Supplements

Oxaliplatin

Irinotecan

Coal Tar

Benzocaine

Angiogenesis Inducing Agents

Tannic Acid

1st line metastatic/locally advanced

* 2nd line metastatic/locally advanced

1. Triple Negative Breast Cancer (TNBC) A 1st line metastatic/locally advanced B ≥2nd line metastatic/locally advanced

1. Non-small Cell Lung Cancer (NSCLC) A ≥2nd line Stage 3B or 4

1. Epithelial Ovarian Cancer (EOC) A 2nd line platinum-resistant Stage 3 or 4 B 2nd line platinum-sensitive Stage 3 or 4 C ≥3rd line platinum-sensitive Stage 3 or 4

1. Colorectal Cancer (CRC) A 1st line Stage 4 B Recurrent or progressive disease following treatment with both oxaliplatin- and irinotecan-containing regimens

CANscript is a predictive test that supports informed selection of cancer therapeutics for each individual patient. CANscript has the potential to predict the response of the patient under evaluation to either single-agent cancer therapeutics or combination therapeutic regimens. This is accomplished by using fresh tumor tissue from the patient in plates coated with a specific set of tumor matrix proteins (TMP). Further, patient derived autologous ligands are added to the culture. Angiogenic factors are added to maintain tumor vasculature along with autologous immune cells. In essence, CANscript recapitulates the tumor microenvironment.

CANscript

Eric Rowinsky, MD

The purpose of this study is to test the CANscript™ sensitivity assay, which is a new and different assay developed to test the sensitivity of different cancer types to physician selected therapies (both drugs and/or drug combinations) indicated for the stage and type of cancer for treatment. CANscript™ tests how a patients specific tumor reacts to the therapies being considered by the treating physician. CANscript™ test results have been shown to closely correspond with actual clinical results, providing physicians with information that may help him/her develop a more personalized cancer treatment and care plan based on the patients specific condition. The researchers want to see if CANscript™ test results are helpful in selecting the treatments prescribed and provided. There will be about 800 people taking part in this study, across 5 different tumor types. The study is designed to assess the decision impact of the CANscript™ test results in informing physicians in therapy selection.

This is an observational data collection study evaluating how physicians utilize therapeutic sensitivity information ascertained with CANscript, and subsequently describing clinical outcomes (clinical response and survival) resulting from their therapeutic selection.

Potential patients presenting for study enrollment will provide written informed consent and will subsequently be screened per inclusion/ exclusion criteria. Once enrolled, a biopsy \& blood draw will be scheduled to obtain material for CANscript testing. Imaging will also be scheduled if a fresh image (obtained within 14 days of planned treatment initiation) is not available. Prior to submitting a fresh tissue sample for CANscript, the treating physician will select any number of therapies being considered for treatment, and will assign a priority ranking to those therapies (priority #1 through priority #N, with #1 representing their most preferred therapeutic option for the patient, and #N representing the number of their least preferred of the appropriate potential therapies). Prioritized therapies can be either single-agent therapeutics or combination regimens. All ranked therapeutic options must be available for individual patient at the time of selection. The prioritized list of preferred therapies will be sent to the testing laboratory (Mitra Biotech, Inc.) at least 2 days before the biopsy and blood draw are performed. Fresh tumor and blood samples will subsequently be sent to the testing laboratory for receipt within 24 hours of biopsy.

Tumor tissue biopsies and resections embedded formalin fixed paraffin and blood

CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2

CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2: A Prospective, Multicenter, Observational Study Examining the Clinical Utility of CANscriptTM in Routine Clinical Practice

1. A questionnaire will be used to capture the information to be able to summarize the concordance and discordance rates between:

1. Empirically selected therapy (selected by treating physicians prior to knowing the CANscript results for a given patient) and CANscript recommended therapy (i.e., the therapy with the highest CANscript M-score for a given patient).
2. Empirically selected therapy and CANscript results that predict response or non-response.

A baseline Image will be taken prior to therapy initiation, and then as per tratment guidelines throughout and following therapy delivery:

1. To summarize tumor response in terms of objective response rate (ORR), clinical benefit rate (CBR), duration of response (DoR) progression-free survival (PFS), and overall survival (OS) based on imaging (CT, MRI, etc.) and scoring per RECIST 1.1 criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer	NCT03096093	Cancer Neoplasms	ACIT-1	18 Years -	Cancer Vaccines Limited
Faith-Based African American Cancer Survivorship Storytelling	NCT03082612	Cancer	Faith-Based Afr...	18 Years - 89 Years	Emory University
Investigation of a Therapeutic Vaccine (ACIT-1) in Cancer	NCT03096093	Cancer Neoplasms	ACIT-1	18 Years -	Cancer Vaccines Limited
CANscriptTM Clinical Outcomes in a Real-World Setting (ANCERS)-2	NCT03253575	Adult Solid Tum...	CANscript	18 Years -	Mitra RxDx, Inc.

Spots Global Cancer Trial Database for late stage cancer