Clinical Trials Search at Vanderbilt-Ingram Cancer Center
Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy versus Standard of Care Chemotherapy Alone for Patients with Unresectable Colorectal Liver Metastases: The PUMP Trial
This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs 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. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.
Not Available
III
Padmanabhan, Sekhar
NCT05863195
VICC-NTGIT23530
Evaluation of Co-formulated Pembrolizumab/Quavonlimab (MK-1308A) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer (CRC) (MK-1308A-008/KEYSTEP-008)
The purpose of this study is to assess the efficacy and safety of co-formulated
pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR
Metastatic Stage IV Colorectal Cancer.
pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR
Metastatic Stage IV Colorectal Cancer.
Not Available
II
Not Available
NCT04895722
VICCGI2145
Testing the Addition of Anti-Cancer Drug, ZEN003694 (ZEN-3694) and PD-1 inhibitor (Pembrolizumab), to Standard Chemotherapy (Nab-Paclitaxel) Treatment in Patients with Advanced Triple-Negative Breast Cancer
Multiple Cancer Types
This phase Ib trial tests the safety and tolerability of ZEN003694 in combination with an immunotherapy drug called pembrolizumab and the usual chemotherapy approach with nab-paclitaxel for the treatment of patients with triple negative-negative breast cancer that has spread to other parts of the body (advanced). Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of paclitaxel which may have fewer side effects and work better than other forms of paclitaxel. Immunotherapy with monoclonal antibodies, such as pembrolizumab may help the body's immune system attach the cancer and may interfere with the ability of tumor cells to grow and spread. ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that over produce BET protein. Combination therapy with ZEN003694 pembrolizumab immunotherapy and nab-paclitaxel chemotherapy may help shrink or stabilize cancer for longer than chemotherapy alone.
Breast,
Phase I
I
Abramson, Vandana
NCT05422794
NCIBREP10525
DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
Breast
Breast
The goal of this trial is to see if active surveillance monitoring and hormonal therapy in
patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast
cancer, can be an effective management of the disease.
Participants will be asked to receive control hormonal therapy or an investigational hormonal
therapy treatment. Participants will be asked to return for evaluation with MRI at three
months and six months. Depending on the evaluation participants will have the option to
continue on the treatment. If the evaluation suggests surgery is recommended, the participant
will discontinue the study treatment and will undergo surgery. In addition to the treatment
and MRI evaluation, participants will be asked to provide blood sample to understand their
immune status, provide saliva sample for genetic testing, provide the study with a portion of
the tissue or slides generated from tissue removed during surgery performed as part of their
standard of care.
patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast
cancer, can be an effective management of the disease.
Participants will be asked to receive control hormonal therapy or an investigational hormonal
therapy treatment. Participants will be asked to return for evaluation with MRI at three
months and six months. Depending on the evaluation participants will have the option to
continue on the treatment. If the evaluation suggests surgery is recommended, the participant
will discontinue the study treatment and will undergo surgery. In addition to the treatment
and MRI evaluation, participants will be asked to provide blood sample to understand their
immune status, provide saliva sample for genetic testing, provide the study with a portion of
the tissue or slides generated from tissue removed during surgery performed as part of their
standard of care.
Breast
II
Meszoely, Ingrid
NCT06075953
VICC-DTBRE23082
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
Breast
Breast
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to
standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with
intermediate-high or high risk for disease recurrence who completed definitive locoregional
therapy (with or without chemotherapy). The planned duration of treatment in either arm
within the study will be 7 years.
standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with
intermediate-high or high risk for disease recurrence who completed definitive locoregional
therapy (with or without chemotherapy). The planned duration of treatment in either arm
within the study will be 7 years.
Breast
III
Reid, Sonya
NCT05952557
VICC-DTBRE23083
Circulating Tumor DNA to Guide Changes in Standard of Care Chemotherapy in Patients with Metastatic Triple Negative Breast Cancer
This phase II trial tests how well evaluating circulating tumor deoxyribonucleic acid (ctDNA) works to guide therapy-change decisions in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic). This study wants to learn if small pieces of DNA associated with a tumor (called circulating tumor DNA, or ctDNA) can be detected in investigational blood tests during the course of standard chemotherapy treatment for breast cancer, and whether information from such investigational ctDNA blood testing could possibly be used as an early indication of chemotherapy treatment failure. It is hoped that additional information from investigational blood testing for ctDNA could help doctors to switch more quickly from a standard chemotherapy treatment that typically has significant side effects and which may not be working, to a different standard treatment regimen against TNBC, called sacituzumab govitecan. Sacituzumab govitecan is a monoclonal antibody, called hRS7, linked to a chemotherapy drug, called irinotecan. hRS7 is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as TROP2 receptors, and delivers irinotecan to kill them. Studying ctDNA may assist doctors to change therapy earlier if needed, and may improve health outcomes in patients with metastatic TNBC.
Not Available
II
Not Available
NCT05770531
VICCBRE2257
Canakinumab for the Prevention of Progression to Cancer in Patients with Clonal Cytopenias of Unknown Significance, IMPACT Study
Leukemia
Leukemia
This phase II trial tests how well canakinumab works to prevent progression to cancer in patients with clonal cytopenias of unknown significance (CCUS). CCUS is a blood condition defined by a decrease in blood cells. Blood cells are composed of either red blood cells, white blood cells, or platelets. In patients with CCUS, blood counts have been low for a long period of time. Patients with CCUS also have a mutation in one of the genes that are responsible for helping blood cells develop. The combination of genetic mutations and low blood cell counts puts patients with CCUS at a higher risk to develop blood cancers in the future. This transformation from low blood cell counts to cancer may be caused by inflammation in the body. Canakinumab is a monoclonal antibody that may block inflammation in the body by targeting a specific antibody called the anti-human interleukin-1beta (IL-1beta).
Leukemia
II
Kishtagari, Ashwin
NCT05641831
VICC-ITHEM23019
Hypofractionated Radiotherapy followed by Surgery for the Treatment of Soft Tissue Sarcomas
Sarcoma
Sarcoma
This phase II trial studies the effect of hypofractionated radiotherapy followed by surgery in treating patients with soft tissue sarcoma. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving hypofractionated radiotherapy followed by surgery may allow patients with sarcomas to be treated in a much more rapid and convenient fashion.
Sarcoma
II
Shinohara, Eric
NCT04506008
VICCSAR2062
Gabapentin plus Ketamine for the Prevention of Acute and Chronic Pain in Patients with Locally Advanced Head and Neck Cancer Undergoing Chemoradiation
Multiple Cancer Types
This phase I/II trial studies the side effects and best dose of a combination of gabapentin and ketamine and to see how well it works to prevent acute and chronic pain in patients receiving chemotherapy and radiation therapy (chemoradiation) for head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced). Gabapentin is a medication that is commonly used to treat nerve related pain. Specifically, it has been used to treat pain involving the mouth, throat and nasal passages in head and neck cancer patients treated with radiation. Ketamine is a type of general anesthetic that blocks pathways to the brain involved with sensing pain. This trial may help doctors determine how patients tolerate the combination of gabapentin and ketamine and to find the correct dosing for ketamine in those taking gabapentin. This will be the basis for a future, larger study to look at how effective this combination is at reducing and/or preventing pain in head and neck cancer patients.
Head/Neck,
Phase I
I/II
Lockney, Natalie
NCT05156060
VICCHNP2173
Heated Intraperitoneal Chemotherapy Followed by Niraparib for Ovarian, Primary Peritoneal and Fallopian Tube Cancer
Ovarian
Ovarian
Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy
(Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4
cycles). Registered patients who progress during neoadjuvant chemotherapy will not be
eligible for iCRS and will be removed from the study.
Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will
be performed in the usual fashion in both arms. Patients will be randomized at the time of
iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter)
to receive HIPEC or no HIPEC. Patients randomized to HIPEC (Arm A) will receive a single dose
of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery
patients will receive standard post-operative platinum-based combination chemotherapy.
Patients randomized to surgery only (Arm B) will receive postoperative standard chemotherapy
after recovery from surgery.
Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy
per institutional standard (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on
Day 1 every 21 days for 2-3 cycles) for a maximum total of 6 cycles of chemotherapy
(neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing until
progression or 36 months (if no evidence of disease).
(Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on Day 1 every 21 days for 3-4
cycles). Registered patients who progress during neoadjuvant chemotherapy will not be
eligible for iCRS and will be removed from the study.
Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will
be performed in the usual fashion in both arms. Patients will be randomized at the time of
iCRS (iCRS must achieve no gross residual disease or no disease >1.0 cm in largest diameter)
to receive HIPEC or no HIPEC. Patients randomized to HIPEC (Arm A) will receive a single dose
of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery
patients will receive standard post-operative platinum-based combination chemotherapy.
Patients randomized to surgery only (Arm B) will receive postoperative standard chemotherapy
after recovery from surgery.
Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy
per institutional standard (Paclitaxel 175 mg/m2 IV over 3 hours and Carboplatin AUC 6 IV on
Day 1 every 21 days for 2-3 cycles) for a maximum total of 6 cycles of chemotherapy
(neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing until
progression or 36 months (if no evidence of disease).
Ovarian
III
Crispens, Marta
NCT05659381
VICC-DTGYN23355
