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Clinical Trials Search at Vanderbilt-Ingram Cancer Center



Standard Chemotherapy in Treating Young Patients with Medulloblastoma or Other Central Nervous System Embryonal Tumors

Neuroblastoma (Pediatrics)

This phase IV trial studies how well standard chemotherapy works in treating young patients with medulloblastoma or other central nervous system embryonal tumors. Drugs used in standard chemotherapy 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.
Neuroblastoma (Pediatrics)
IV
Esbenshade, Adam
NCT02875314
VICCPED1751

LCH-IV, International Collaborative Treatment Protocol for Children and Adolescents With Langerhans Cell Histiocytosis

Multiple Cancer Types

The LCH-IV is an international, multicenter, prospective clinical study for pediatric
Langerhans Cell Histiocytosis LCH (age < 18 years).
Miscellaneous, Pediatrics
III
Pastakia, Devang
NCT02205762
VICCPED2231

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

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

Inotuzumab Ozogamicin and Post-Induction Chemotherapy in Treating Patients with High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and B-LLy

Multiple Cancer Types

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy.

The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.
Pediatric Leukemia, Pediatrics
III
Friedman, Debra
NCT03959085
COGAALL1732

Genetics of Appendix Cancer: The GAP Study

Colon

Colon
N/A
Holowatyj, Andreana
NCT05734430
VICCGI2280

Preserving Fertility After Colorectal Cancer: The PREFACE Study

Multiple Cancer Types

Colon, Rectal
N/A
Holowatyj, Andreana
NCT05239338
VICCGI2186

Enhanced Recovery After Surgery for Pain Management in Patients with Extremity Soft Tissue Sarcoma

Sarcoma

This clinical trial studies the effect of the ERAS pain management method in managing pain after surgery in patients with extremity soft tissue sarcoma. Enhanced Recovery After Surgery, or ERAS, is a pain management method that places emphasis on managing risk factors (things like smoking, nutrition and fitness), using multiple types of pain control, and early movement, with the goal of improving patient outcomes. ERAS has been shown to reduce the length of time some patients stay in the hospital, reduce complications from surgery, and even lower costs of some surgeries. ERAS is designed may help cut down on the use of these narcotics in managing the pain of surgery patients. The purpose of this trial is to demonstrate that ERAS is safe and effective for patients having surgery to treat their sarcoma. Specifically, this study will look at using a non-narcotic pain management program that includes other methods of managing the pain of sarcoma surgery patients.
Sarcoma
N/A
Lawrenz, Joshua
NCT04461171
VICCSAR2020

A Study to See if Memantine Protects the Brain during Radiation Therapy Treatment for Primary Central Nervous System Tumors

Multiple Cancer Types

This phase III trial compares memantine to usual treatment in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary central nervous system tumors.
Neuro-Oncology, Pediatrics
III
Esbenshade, Adam
NCT04939597
COGACCL2031

Treatment Response and Biomarker-Guided Steroid Taper for Children with GVHD

Multiple Cancer Types

This phase II trial studies the treatment response for patients with acute graft-versus-host disease (GVHD). GVHD occurs when donor immune cells attack the healthy tissue of a bone marrow or stem cell transplant patient. The standard treatment for GVHD is to lower the activity of the donor cells by using steroid medications such as prednisone. But steroid treatment may cause many complications and the risk of these complications increases with higher doses of steroids and longer treatment. It is important to find ways to decrease the steroid treatment in patients who do not need long courses. Researchers are doing this study to find out how many subjects respond well to lower steroid dosing based on a blood test (GVHD biomarker) and if they develop fewer complications.
Miscellaneous, Pediatrics
II
Kitko, Carrie
NCT05090384
VICCPED2213

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