Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Evaluation of Patient Reported Outcomes in Patients with Digestive System and Lung Neuroendocrine Cancer, NET-PRO study
Gastrointestinal
Gastrointestinal
This study evaluates the patient reported outcomes in patients with digestive system neuroendocrine cancer and lung neuroendocrine cancer. Patients with neuroendocrine cancer usually have a high symptom burden which may have a negative effect on health-related quality of life (HRQoL). Patient questionnaires gather information describing symptoms and effect on quality of life, cancer type and any treatments received. Studying quality of life in patients receiving treatment for neuroendocrine cancers may help identify the effects of treatment and improve future treatment plans. Information gathered from this study may help researchers understand whether patient's diagnosis, symptoms, and order of cancer treatments have any effect on quality of life.
Gastrointestinal
N/A
Ramirez, Robert
NCT05064150
VICCGI2247
Biomarker Verification in Pediatric Chronic GvHD: ABLE 2.0 / PTCTC GVH 1901 Study
This study will validate a previously developed pediatric prognostic biomarker algorithm
aimed at improving prediction of risk for the later development of chronic graft-versus-host
disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell
transplant.
By developing an early risk stratification of patients into low-, intermediate-, and
high-risk for future cGvHD development (based upon their biomarker profile, before the onset
of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed
based upon an individual's biological risk profile.
This study will also continue research into diagnostic biomarkers of cGvHD, and begin work
into biomarker models that predict clinical response to cGvHD therapies.
aimed at improving prediction of risk for the later development of chronic graft-versus-host
disease (cGvHD) in children and young adults undergoing allogeneic hematopoietic stem cell
transplant.
By developing an early risk stratification of patients into low-, intermediate-, and
high-risk for future cGvHD development (based upon their biomarker profile, before the onset
of cGvHD), pre-emptive therapies aimed at preventing the onset of cGvHD can be developed
based upon an individual's biological risk profile.
This study will also continue research into diagnostic biomarkers of cGvHD, and begin work
into biomarker models that predict clinical response to cGvHD therapies.
Not Available
N/A
Kitko, Carrie
NCT04372524
VICCPED2183
cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
Miscellaneous
Miscellaneous
This is an observational case-control study to train and validate a genome-wide methylome
enrichment platform to detect multiple cancer types and to differentiate amongst cancer
types. The cancers included in this study are brain, breast, bladder, cervical, colorectal,
endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma,
multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers
were selected based on their prevalence and mortality to maximize impact on clinical care.
Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal
residual disease after completion of cancer treatment and to detect relapse prior to clinical
presentation will be evaluated in four cancer types (breast, colorectal, lung, prostate).
These cancers were selected based on the existing clinical landscape and treatment
availability.
enrichment platform to detect multiple cancer types and to differentiate amongst cancer
types. The cancers included in this study are brain, breast, bladder, cervical, colorectal,
endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma,
multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers
were selected based on their prevalence and mortality to maximize impact on clinical care.
Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal
residual disease after completion of cancer treatment and to detect relapse prior to clinical
presentation will be evaluated in four cancer types (breast, colorectal, lung, prostate).
These cancers were selected based on the existing clinical landscape and treatment
availability.
Miscellaneous
N/A
Rini, Brian
NCT05366881
VICCMD21111
A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)
Breast
Breast
This is a Phase III, randomized, open-label, 3-arm, multicenter, international study
assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in
participants with stage I to III TNBC with residual invasive disease in the breast and/or
axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in
participants with stage I to III TNBC with residual invasive disease in the breast and/or
axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
Breast
III
Reid, Sonya
NCT05629585
VICC-DTBRE23074
HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide
Multiple Cancer Types
This is a prospective, multi-center, Phase II study of hematopoietic cell transplantation
(HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral
blood stem cell transplant in adults and bone marrow stem cell transplant in children.
Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be
used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well
this treatment works in patients with hematologic malignancies.
(HCT) using human leukocyte antigen (HLA)-mismatched unrelated donors (MMUD) for peripheral
blood stem cell transplant in adults and bone marrow stem cell transplant in children.
Post-transplant cyclophosphamide (PTCy), tacrolimus and mycophenolate mofetil (MMF) will be
used for for graft versus host disease (GVHD) prophylaxis. This trial will study how well
this treatment works in patients with hematologic malignancies.
Hematologic,
Leukemia,
Lymphoma,
Myelodysplastic Syndrome
II
Dholaria, Bhagirathbhai
NCT04904588
VICCCTT2171
Treosulfan-Based Conditioning Regimen before a Blood or Bone Marrow Transplant for the Treatment of Bone Marrow Failure Diseases (BMT CTN 1904)
Multiple Cancer Types
This phase II trial tests whether treosulfan, fludarabine, and rabbit antithymocyte globulin (rATG) work when given before a blood or bone marrow transplant (conditioning regimen) to cause fewer complications for patients with bone marrow failure diseases. Chemotherapy drugs, such as treosulfan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Fludarabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. rATG is used to decrease the body's immune response and may improve bone marrow function and increase blood cell counts. Adding treosulfan to a conditioning regimen with fludarabine and rATG may result in patients having less severe complications after a blood or bone marrow transplant.
Hematologic,
Pediatrics
II
Connelly, James
NCT04965597
VICCPED2192
Hormonal Therapy after Pertuzumab and Trastuzumab for the Treatment of Hormone Receptor Positive, HER2 Positive Breast Cancer, the ADEPT study
Breast
Breast
This phase II trial studies the effect of hormonal therapy given after (adjuvant) combination pertuzumab/trastuzumab in treating patients with hormone receptor positive, HER2 positive breast cancer. The drugs trastuzumab and pertuzumab are both monoclonal antibodies, which are disease-fighting proteins made by cloned immune cells. Estrogen can cause the growth of breast cancer cells. Hormonal therapy, such as letrozole, anastrozole, exemestane, and tamoxifen, block the use of estrogen by the tumor cells. Giving hormonal therapy after pertuzumab and trastuzumab may kill any remaining tumor cells in patients with breast cancer.
Breast
II
Abramson, Vandana
NCT04569747
VICCBRE2243
Testing Lutetium Lu 177 Dotatate in Patients with Somatostatin Receptor Positive Advanced Bronchial Neuroendocrine Tumors
Lung
Lung
This phase II trial studies the effect of lutetium Lu 177 dotatate compared to the usual treatment (everolimus) in treating patients with somatostatin receptor positive bronchial neuroendocrine tumors that have spread to other places in the body (advanced). Radioactive drugs, such as lutetium Lu 177 dotatate, may carry radiation directly to tumor cells and may reduce harm to normal cells. Lutetium Lu 177 dotatate may be more effective than everolimus in shrinking or stabilizing advanced bronchial neuroendocrine tumors.
Lung
II
Ramirez, Robert
NCT04665739
SWOGTHOA021901
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Multiple Cancer Types
The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab)
taken alone or together with standard chemotherapy for the potential treatment of colorectal
cancer that:
- has spread to other parts of the body (metastatic);
- has a certain type of abnormal gene called "BRAF"; and
- has not received prior treatment.
Participants in this study will receive one of the following study treatments:
- Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home
every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection
into the vein) at the study clinic.
- Encorafenib plus cetuximab with chemotherapy: These participants will receive
encorafenib and cetuximab in the way described in the bullet above. Additionally, they
will receive standard chemotherapy by IV infusion and oral treatment at home.
- Chemotherapy alone: These participants will receive chemotherapy, the standard treatment
for this condition, by IV infusion at the study clinics and oral treatment at home.
The study team will monitor how each participant responds to the study treatment for up to
about 3 years.
taken alone or together with standard chemotherapy for the potential treatment of colorectal
cancer that:
- has spread to other parts of the body (metastatic);
- has a certain type of abnormal gene called "BRAF"; and
- has not received prior treatment.
Participants in this study will receive one of the following study treatments:
- Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home
every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection
into the vein) at the study clinic.
- Encorafenib plus cetuximab with chemotherapy: These participants will receive
encorafenib and cetuximab in the way described in the bullet above. Additionally, they
will receive standard chemotherapy by IV infusion and oral treatment at home.
- Chemotherapy alone: These participants will receive chemotherapy, the standard treatment
for this condition, by IV infusion at the study clinics and oral treatment at home.
The study team will monitor how each participant responds to the study treatment for up to
about 3 years.
Colon,
Rectal
III
Eng, Cathy
NCT04607421
VICCGI2085
Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)
Multiple Cancer Types
The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized
interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy
of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed
acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have
comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of
the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination
therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax)
exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and
venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will
follow the same overall study design as Phase 1 and has two parts, Part A and Part B.
interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy
of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed
acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have
comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of
the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination
therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax)
exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and
venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will
follow the same overall study design as Phase 1 and has two parts, Part A and Part B.
Leukemia,
Phase I
I/II
Savona, Michael
NCT04657081
VICCHEMP20102
