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
Study of Lurbinectedin in Combination With Doxorubicin Versus Doxorubicin Alone as First-line Treatment in Participants With Metastatic Leiomyosarcoma
Sarcoma
Sarcoma
The primary objective of this phase IIb/III study is to evaluate whether the combination of
lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma
(LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when
compared to doxorubicin administered as a single agent.
lurbinectedin plus doxorubicin given as first line treatment for metastatic leiomyosarcoma
(LMS) prolongs the progression-free survival (PFS) by Independent Review Committee (IRC) when
compared to doxorubicin administered as a single agent.
Sarcoma
II/III
Davis, Elizabeth
NCT06088290
VICC-DTSAR23232
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
This phase II ComboMATCH treatment trial compares the effect of neratinib to the combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors. Neratinib and palbociclib are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of tumor cells. Giving neratinib and palbociclib in combination may shrink or stabilize cancers that over-express a specific biomarker called HER2.
Not Available
II
Choe, Jennifer
NCT06126276
ECOGMDEAY191-N5
A Study Using a New Drug, Nivolumab, in Combination with Chemotherapy Drugs to Treat a Type of Cancer Called Nasopharyngeal Carcinoma (NPC)
This phase II trial tests how well nivolumab in combination with chemotherapy drugs along with radiation therapy works in treating patients with nasopharyngeal cancer. 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 gemcitabine and cisplatin, 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. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Researchers want to find out what effects, good and/or bad, adding nivolumab to chemotherapy has on patients with newly diagnosed NPC. In addition, they want to find out if children with NPC may be treated with less radiation therapy and whether this decreases the side effects of therapy.
Not Available
II
Not Available
NCT06064097
VICC-NTPED24105
Durvalumab with Gemcitabine and Cisplatin for the Treatment of High Risk Resectable Liver Cancer Before Surgery
This phase II trial tests how well giving durvalumab with standard chemotherapy, gemcitabine and cisplatin, before surgery works in treating patients with high risk liver cancer (cholangiocarcinoma) that can be removed by surgery (resectable). Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as gemcitabine and cisplatin, 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 durvalumab with gemcitabine and cisplatin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed in patients with high risk resectable cholangiocarcinoma.
Not Available
II
Heumann, Thatcher
NCT06050252
ETCGI10608
P-CD19CD20-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With B Cell Malignancies
Lymphoma
Lymphoma
Phase 1 study comprised of open-label, dose escalation and expansion cohort study of
P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with
relapsed/refractory B cell malignancies
P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with
relapsed/refractory B cell malignancies
Lymphoma
I
Dholaria, Bhagirathbhai
NCT06014762
VICC-DTCTT23163P
A Study to Evaluate the Safety and Tolerability of TOS-358 in Adults With Select Solid Tumors
Multiple Cancer Types
The goal of this clinical trial is to evaluate the safety of TOS-358 in adults with select
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
solid tumors who meet study enrollment criteria. The main questions it aims to answer are:
1. what is the maximum tolerated dose and recommended dose for phase 2?
2. how safe and tolerable is TOS-358 at different dose levels when taken orally once or
twice per day?
Breast,
Cervical,
Gastrointestinal,
Gynecologic,
Head/Neck,
Lung,
Phase I,
Urologic
I
Berlin, Jordan
NCT05683418
VICC-DTPHI23103
A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
This study is being done to find out if tucatinib with other cancer drugs works better than
standard of care to treat participants with HER2 positive colorectal cancer. This study will
also test what side effects happen when participants take this combination of drugs. A side
effect is anything a drug does to the body besides treating your disease.
Participants in this study have colorectal cancer that has spread through the body
(metastatic) and/or cannot be removed with surgery (unresectable).
Participants will be assigned randomly to the tucatinib group or standard of care group. The
tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group
will get either:
- mFOLFOX6 alone,
- mFOLFOX6 with bevacizumab, or
- mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs
given in this study are used to treat this type of cancer.
standard of care to treat participants with HER2 positive colorectal cancer. This study will
also test what side effects happen when participants take this combination of drugs. A side
effect is anything a drug does to the body besides treating your disease.
Participants in this study have colorectal cancer that has spread through the body
(metastatic) and/or cannot be removed with surgery (unresectable).
Participants will be assigned randomly to the tucatinib group or standard of care group. The
tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group
will get either:
- mFOLFOX6 alone,
- mFOLFOX6 with bevacizumab, or
- mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs
given in this study are used to treat this type of cancer.
Not Available
III
Not Available
NCT05253651
VICC-DTGIT23052
A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor
Multiple Cancer Types
The primary objective of this study is to assess the safety and tolerability and to determine
the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).
the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s).
Gynecologic,
Liver,
Phase I
I
Crispens, Marta
NCT04008797
VICC-DTPHI23106
