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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Capecitabine Compared to Endocrine Therapy for the Treatment of Non-luminal A Hormone Receptor-Positive Metastatic Breast Cancer

Breast

This phase II trial compares the effect of capecitabine to endocrine therapy in patients with non-Luminal A hormone receptor-positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). In this study, patients submit a sample of tumor for testing to determine if their breast cancer is considered non-Luminal A. Only patients with non-Luminal A receive study treatment. In the future, doctors hope that this test can assist in picking the best treatment for patients with this type of cancer. Capecitabine is in a class of medications called antimetabolites. It is taken up by tumor cells and breaks down into fluorouracil, a substance that kills tumor cells. Endocrine therapy is treatment that adds, blocks, or removes hormones. To slow or stop the growth of certain cancers (such as prostate and breast cancer), synthetic hormones or other drugs may be given to block the body's natural hormones. Giving capecitabine as compared to endocrine therapy may kill more tumor cells in patients with metastatic breast cancer.
Breast
II
Reid, Sonya
NCT05693766
VICCBRE2256

A Randomized Study Investigating Preoperative Chemotherapy Followed by Surgery versus Surgery Alone in Patients with High Risk Retroperitoneal Sarcoma, STRASS2 Trial

Sarcoma

This phase III trial compares the effect of adding chemotherapy (doxorubicin or epirubicin hydrochloride [epirubicin] with ifosfamide or dacarbazine) before standard surgery versus surgery alone in improving long-term survival in patients with retroperitoneal sarcomas that are able to be removed by surgery (resectable). Chemotherapy drugs, such as doxorubicin, epirubicin, ifosfamide, and dacarbazine, 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. Giving chemotherapy before surgery may make the tumor smaller and easier to remove and may increase patient survival, compared to surgery alone.
Sarcoma
III
Davis, Elizabeth
NCT04031677
VICC-NTSAR23088

First in Human Study of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia

Multiple Cancer Types

This first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess
ziftomenib, a menin-MLL(KMT2A) inhibitor, in patients with relapsed or refractory acute
myeloid leukemia (AML) as part of Phase 1. In Phase 2, assessment of ziftomenib will continue
in patients with NPM1-m AML.
Leukemia, Phase I
I/II
Savona, Michael
NCT04067336
VICCHEMP20122

CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy for Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER)

Multiple Cancer Types

CB010A is a study evaluating safety, emerging efficacy, pharmacokinetics and immunogenicity
of CB-010 in adults with relapsed/refractory B cell non-Hodgkin lymphoma after
lymphodepletion consisting of cyclophosphamide and fludarabine.
Lymphoma, Phase I
I
Oluwole, Olalekan
NCT04637763
VICC-DTCTT23155P

Testing Atezolizumab Alone or Atezolizumab Plus Bevacizumab in People with Advanced Alveolar Soft Part Sarcoma

Sarcoma

This phase II trial studies how well atezolizumab or atezolizumab plus bevacizumab works in treating patients with alveolar soft part sarcoma that has not been treated, has spread from where it started to other places in the body (advanced) and cannot be removed by surgery (unresectable). Atezolizumab works by unblocking the immune system, allowing the immune system cells to recognize and then attack tumor cells. Bevacizumab works by controlling the growth of new blood vessels. Giving atezolizumab alone or atezolizumab with bevacizumab may shrink the cancer.
Sarcoma
II
Davis, Elizabeth
NCT03141684
VICCSAR16155ET-CT

Tiragolumab and Atezolizumab for the Treatment of Relapsed or Refractory SMARCB1 or SMARCA4 Deficient Tumors

Pediatrics

This phase I/II trial studies how well tiragolumab and atezolizumab works when given to children and adults with SMARCB1 or SMARCA4 deficient tumors that that has either come back (relapsed) or does not respond to therapy (refractory). SMARCB1 or SMARCA4 deficiency means that tumor cells are missing the SMARCB1 and SMARCA4 genes, seen with some aggressive cancers that are typically hard to treat. Immunotherapy with monoclonal antibodies, such as tiragolumab and atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Pediatrics
I/II
Borinstein, Scott
NCT05286801
COGPEPN2121

(Peak) A Phase 3 Randomized Trial of CGT9486+Sunitinib vs. Sunitinib in Subjects With Gastrointestinal Stromal Tumors

GIST

This is a Phase 3, open-label, international, multicenter study of CGT9486 in combination
with sunitinib. This is a multi-part study that will enroll approximately 426 patients. Part
1 consists of two evaluations: 1) confirming the dose of an updated formulation of CGT9486 to
be used in subsequent parts in approximately 20 patients who have received at least one prior
line of therapy for GIST and 2) evaluating for drug-drug interactions between CGT9486 and
sunitinib in approximately 18 patients who have received at least two prior tyrosine kinase
inhibitors (TKIs) for GISTs. The second part of the study will enroll approximately 388
patients who are intolerant to, or who failed prior treatment with imatinib only and will
compare the efficacy of CGT9486 plus sunitinib to sunitinib alone with patients being
randomized in a 1:1 manner.
GIST
III
Davis, Elizabeth
NCT05208047
VICCSAR21116

A Study to Evaluate the Efficacy and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis

Hematologic

A Phase 3 study to evaluate the efficacy and safety of birtamimab plus standard of care
compared to placebo plus standard of care in Mayo Stage IV patients with AL amyloidosis.
Hematologic
III
Baljevic, Muhamed
NCT04973137
VICCPCL22109

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

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.
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.
Hematologic, Leukemia, Lymphoma, Myelodysplastic Syndrome
II
Dholaria, Bhagirathbhai
NCT04904588
VICCCTT2171

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