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KaCrole Higgins was diagnosed with breast cancer in 2020. “In May 2020, I found a lump in my breast. I cried. By June, it was diagnosed as breast cancer, triple positive, stage 1A. While getting this cancer diagnosis was devastating, it also became an opportunity. Suddenly, the cancer gave me clarity. It gave me clarity about what was important, what was good in my life, what was toxic in my life, and what I needed to do.” Click below to read more of KaCrole’s story |
If Landon Ryan had been diagnosed with bilateral retinoblastoma 10, 20 or 30 years ago, she might not be here today with nearly perfect vision.Thanks to recent improvements in the treatment for this rare form of cancer that almost exclusively affects children under the age of 5, the diagnosis had the power to change Landon’s life when she was 11 months old, but not to take it — or her eyesight. Click below to learn more about Landon and her story. https://momentum.vicc.org/2022/04/brighter-outlook/ |
A Multi-Institution Study of TGF Imprinted, Ex Vivo Expanded Universal Donor NK Cell Infusions as Adoptive Immunotherapy in Combination With Gemcitabine and Docetaxel in Patients With Relapsed or Refractory Pediatric Bone and Soft Tissue
Multiple Cancer Types
The purpose of this study is to determine if the addition of infusions of a type of immune cell called a "natural killer", or NK cell to the sarcoma chemotherapy regimen GEM/DOX (gemcitabine and docetaxel) can improve outcomes in people with childhood sarcomas that have relapsed or not responded to prior therapies.
The goals of this study are:
* To determine the safety and efficacy of the addition of adoptive transfer of universal donor, TGF imprinted (TGFi), expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabine/docetaxel (GEM/DOX) for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.
* To identify toxicities related to treatment with GEM/DOX + TGFi expanded NK cells
Participants will receive study drugs that include chemotherapy and NK cells in cycles; each cycle is 21 days long and you can receive up to 8 cycles.
* Gemcitabine (GEM): via IV on Days 1 and 8
* Docetaxel (DOX): via IV on Day 8
* Prophylactic dexamethasone: Day 7-9 to prevent fluid retention and hypersensitivity reaction
* Peg-filgrastim (PEG-GCSF) or biosimilar: Day 9 to help your white blood cell recover and allow more chemotherapy to be given
* TGFi NK cells: via IV on Day 12
The goals of this study are:
* To determine the safety and efficacy of the addition of adoptive transfer of universal donor, TGF imprinted (TGFi), expanded NK cells to the pediatric sarcoma salvage chemotherapeutic regimen gemcitabine/docetaxel (GEM/DOX) for treatment of relapsed and refractory pediatric sarcomas To determine the 6-month progression free survival achieved with this treatment in patients within cohorts of relapsed or refractory osteosarcoma, Ewing sarcoma, rhabdomyosarcoma and non-rhabdomyosarcoma soft tissue sarcoma.
* To identify toxicities related to treatment with GEM/DOX + TGFi expanded NK cells
Participants will receive study drugs that include chemotherapy and NK cells in cycles; each cycle is 21 days long and you can receive up to 8 cycles.
* Gemcitabine (GEM): via IV on Days 1 and 8
* Docetaxel (DOX): via IV on Day 8
* Prophylactic dexamethasone: Day 7-9 to prevent fluid retention and hypersensitivity reaction
* Peg-filgrastim (PEG-GCSF) or biosimilar: Day 9 to help your white blood cell recover and allow more chemotherapy to be given
* TGFi NK cells: via IV on Day 12
Pediatrics,
Sarcoma
I/II
Borinstein, Scott
NCT05634369
VICCPED24617
pBI-11 & TA-HPV (With Pembrolizumab as Treatment for Patients w/Advanced, PD-L1 CPS1, hrHPV+ Oropharyngeal Cancer
This phase II trial tests how well pB1-11 and human papillomavirus tumor antigen (TA-HPV) vaccines in combination with pembrolizumab work in treating patients with oropharyngeal cancer that has come back (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic) and that is PD-L1 and human papillomavirus (HPV) positive. Oropharyngeal cancer is a type of head and neck cancer involving structures in the back of the throat (the oropharynx), such as the non-bony back roof of the mouth (soft palate), sides and back wall of the throat, tonsils, and back third of the tongue. Scientists have found that some strains or types of a virus called HPV can cause oropharyngeal cancer. pBI-11 is a circular deoxyribonucleic acid (DNA) (plasmid) vaccine that promotes antibody, cytotoxic T cell, and protective immune responses. TA-HPV is an investigational recombinant vaccina virus derived from a strain of the vaccina virus which was widely used for smallpox vaccination. Vaccination with this TA-HPV vaccine may stimulate the immune system to mount a cytotoxic T cell response against tumor cells positive for HPV, resulting in decreased tumor growth. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread by inhibiting the PD-1 receptor. These investigational vaccines could cause or enhance an immune response in the body against HPV, during which time the activity of pembrolizumab against oropharyngeal cancer associated with HPV may be strengthened. These drugs in combination may be more effective in increasing the ability of the immune system to fight oropharyngeal cancer than pembrolizumab alone.
Not Available
II
Not Available
NCT05799144
VICCHN2208
Hypofractionated Radiotherapy Followed by Surgical Resection in the Treatment of Soft Tissue Sarcomas
Sarcoma
Sarcoma
The trial will use neoadjuvant hypofractionated radiotherapy followed by surgical resection in the treatment for soft tissue sarcoma. It will allow patients to be treated over a shorter course (5 or 15 days of radiation) compared to the traditional 5 week regimen. It is proposed that this will be possible without increasing the risk of wound complication or local recurrence compared with a traditional 5 week course of pre-operative radiation.
Sarcoma
II
Shinohara, Eric
NCT04506008
VICCSAR2062
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
Multiple Cancer Types
This ComboMATCH patient screening trial is the gateway to a coordinated set of clinical trials to study cancer treatment directed by genetic testing. Patients with solid tumors that have spread to nearby tissue or lymph nodes (locally advanced) or have spread to other places in the body (advanced) and have progressed on at least one line of standard systemic therapy or have no standard treatment that has been shown to prolong overall survival may be candidates for these trials. Genetic tests look at the unique genetic material (genes) of patients' tumor cells. Patients with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation. ComboMATCH is designed to match patients to a treatment that may work to control their tumor and may help doctors plan better treatment for patients with locally advanced or advanced solid tumors.
Breast,
Gastrointestinal,
Gynecologic,
Head/Neck,
Lung,
Melanoma,
Neuro-Oncology,
Sarcoma,
Urologic
II
Choe, Jennifer
NCT05564377
VICC-NTMDT23238
Testing the Addition of an Anti-Cancer Drug, ZEN003694, to the Usual Chemotherapy Treatment (Capecitabine) for Metastatic or Unresectable Cancers
Multiple Cancer Types
This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with the usual treatment with capecitabine in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable) and that it has progressed on previous standard treatment. 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. Capecitabine is in a class of medications called antimetabolites. It is taken up by cancer cells and breaks down into fluorouracil, a substance that kills cancer cells. Giving ZEN003694 in combination with capecitabine may be safe in treating patients with metastatic or unresectable solid tumors.
Colon,
Phase I,
Rectal
I
Heumann, Thatcher
NCT05803382
VICC-NTPHI23420
Testing Nivolumab and Ipilimumab Immunotherapy With or Without the Targeted Drug Cabozantinib in Recurrent, Metastatic, or Incurable Nasopharyngeal Cancer
Head/Neck
Head/Neck
This phase II trial tests how well nivolumab and ipilimumab immunotherapy with or without cabozantinib works in treating patients with nasopharyngeal cancer that has come back (after a period of improvement) (recurrent), has spread from where it first started (primary site) to other places in the body (metastatic), or for which no treatment is currently available (incurable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving immunotherapy with nivolumab and ipilimumab and targeted therapy with cabozantinib may help shrink and stabilize nasopharyngeal cancer.
Head/Neck
II
Choe, Jennifer
NCT05904080
ALLHNA092105
A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
Multiple Cancer Types
This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.
Pediatric Lymphoma,
Pediatrics
III
Smith, Christine
NCT05675410
VICC-NTPED23306
Evaluating the Use of Dual Imaging Techniques for Detection of Disease in Patients With Head and Neck Cancer
Phase I
Phase I
This phase I trial evaluates the safety and effectiveness of using two imaging techniques, indium In 111 panitumumab (111In-panitumumab) with single photon emission computed tomography (SPECT)/computed tomography (CT) and panitumumab-IRDye800 fluorescence imaging during surgery (intraoperative), to detect disease in patients with head and neck cancer. 111In-panitumumab is an imaging agent made of a monoclonal antibody that has been labeled with a radioactive molecule called indium In 111. The agent targets and binds to receptors on tumor cells. This allows the cells to be visualized and assessed with SPECT/CT imaging techniques. SPECT is special type of CT scan in which a small amount of a radioactive drug is injected into a vein and a scanner is used to make detailed images of areas inside the body where the radioactive material is taken up by the cells. CT is an imaging technique for examining structures within the body by scanning them with x-rays and using a computer to construct a series of cross-sectional scans along a single axis. Panitumumab-IRDye800 is an imaging agent composed of panitumumab, a monoclonal antibody, linked to a fluorescent dye called IRDye800. Upon administration, panitumumab-IRDye800 targets and binds to receptors on tumor cells. This allows the tumor cells to be detected using fluorescence imaging during surgery. Adding 111In-panitumumab SPECT/CT imaging to intraoperative panitumumab-IRDye800 fluorescence imaging may be more effective at detecting disease in patients with head and neck cancer.
Phase I
I
Rosenthal, Eben
NCT05945875
VICC-EDHAN23204P
Chemotherapy for the Treatment of Patients With Newly Diagnosed Very Low-Risk and Low Risk Fusion Negative Rhabdomyosarcoma
Pediatrics
Pediatrics
Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.
Pediatrics
III
Borinstein, Scott
NCT05304585
COGARST2032
A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis
Leukemia
Leukemia
This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.
Leukemia
I/II
Kishtagari, Ashwin
NCT04176198
VICC-DTHEM23002P
