Pivotal Trial

The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)

Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer

Immunotherapy with DCVax-L for Brain Cancer

This study is evaluating whether a vaccine can improve survival for people with brain cancer.

I stopped taking steroids at least 10 days before my leukapheresis.

My initial treatment was surgery to remove as much of the tumor as possible, followed by radiation and Temodar chemotherapy.

I agree not to receive certain cancer treatments except for temozolomide as per the Stupp Protocol while on DCVax-L.

My tumor sample from surgery is enough for the protein test.

I have enough DCVax-L available for treatment after it was made.

I have been diagnosed with Grade IV brain cancer in one side of my brain.

My bone marrow, liver, and kidneys are working well.

I am between 18 and 70 years old and can legally consent.

My cancer did not worsen after finishing radiation therapy.

DCVax®-L

Approved for 5 Other Conditions

No Placebo-Only Group

Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML.

The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.

Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study

Amonafide vs Daunorubicin for Acute Myeloid Leukemia

This study is evaluating whether a drug called amonafide can be used to treat people with acute myeloid leukemia.

I have been diagnosed with a type of leukemia (AML) that is not the M3 type.

I have an active hepatitis B or C infection, or another active liver disease.

I have not had major surgery or radiation therapy in the last 4 weeks.

I can fully participate in all parts of the clinical trial.

I haven't had chemotherapy for MDS in the last 4 weeks.

My heart's pumping ability is good, confirmed by a test within the last 2 weeks.

My chest X-ray and CT show a lung infection.

I have lasting side effects from previous MDS treatment.

I was treated for a non-blood condition or diagnosed with MDS for 3+ months.

I have been diagnosed with a specific type of leukemia called FAB M3.

My leukemia is affecting my brain or spinal cord.

I have received initial treatment for acute myeloid leukemia.

I can take care of myself but might not be able to do heavy physical work.

My kidney function is within normal limits.

Amonafide

Daunorubicin

This is a nonrandomized study of ruxolitinib in combination with a standard multi-agent chemotherapy regimen for the treatment of B-cell acute lymphoblastic leukemia. Part 1 of the study will optimize the dose of study drug (ruxolitinib) in combination with the chemotherapy regimen. Part 2 will evaluate the efficacy of combination chemotherapy and ruxolitinib at the recommended dose determined in Part 1.

A Phase 2 Study of Ruxolitinib With Chemotherapy in Children With Acute Lymphoblastic Leukemia

Ruxolitinib + Chemotherapy for Leukemia

This study is evaluating whether a drug called ruxolitinib may help treat acute lymphoblastic leukemia.

My kidney function, measured by creatinine clearance, is below 70 mL/min.

I finished a 4-drug treatment and had a test for remaining cancer cells.

I am not able to have children or I agree to use birth control during the study.

I am between 2 and 21 years old and live in Canada.

I was diagnosed between the ages of 1 and 21.

My leukemia is high-risk and was identified as Ph-like at diagnosis.

My cancer has been analyzed for specific gene changes.

My liver enzyme (ALT) levels are five times higher than normal.

I have only received hydroxyurea or steroids before my main cancer treatment.

Ruxolitinib

Investigators are evaluating the feasibility, safety and early efficacy of administering a commercially available dietary supplement containing potato-based resistant starch to subjects undergoing allogeneic SCT (stem cell transplant). The intervention will begin immediately prior to the conditioning phase and continue through day 100. Investigators hypothesize that short term administration of a resistant starch is capable of increasing levels of butyrate within the intestine that will reduce rates of acute GVHD (Graft-Versus-Host Disease).

Dietary Manipulation of the Microbiome-metabolomic Axis for Mitigating GVHD in Allo HCT Patients

Potato-Based Supplement for Bone Marrow Transplant Patients

This study is evaluating whether a dietary supplement may help reduce the severity of graft-versus-host disease following stem cell transplant.

I currently have an active Clostridium difficile infection confirmed by a stool test.

I am at least 18 years old for the initial phase, or over 10 and weigh more than 50 kg for the next phase.

I am able to care for myself but may not be able to do active work.

I am getting a stem cell transplant from a closely related donor.

I have had gastric bypass surgery in the past.

I have a family member who is an HLA match for me.

Bob's Red Mill®

Starch Placebo

This study will be a non-randomized pilot trial using Cyclophosphamide and Sirolimus for the treatment of metastatic differentiated thyroid cancer. Patients will be treated with Sirolimus 4 mg, PO, days 1-28 as well as Cyclophosphamide 100 mg, PO, days 1-5 and 15-19. Cycle length will be 28 days. Patients will be monitored closely for toxicity and undergo imaging to evaluate efficacy once every 2 cycles.

Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer

Cyclophosphamide + Sirolimus for Advanced Thyroid Cancer

This study is evaluating whether a combination of two drugs may help treat thyroid cancer.

I do not have any serious health issues or infections that would stop me from receiving the study treatment.

I am allergic to cyclophosphamide or sirolimus.

I am mentally capable of understanding and following the study's requirements.

I haven't had chemotherapy, radiation, or tyrosine kinase inhibitor treatments in the last 4 weeks.

I have been treated with an mTOR inhibitor before.

I haven't had advanced genetic testing on my cancer.

I am not on strong CYP3A4 or P-glycoprotein inhibitors/inducers, or can stop them a week before starting Cyclophosphamide and Sirolimus.

My stomach or intestines do not work well, affecting how I absorb medicine.

I am not using, or unable to use, birth control or practice abstinence.

My thyroid cancer cannot be cured by surgery or I have chosen not to undergo curative treatment.

My cancer has grown despite treatment, and I have a tumor larger than 10 mm.

My organs and bone marrow are working well.

I am willing and able to follow the study's schedule and procedures.

I am able to get out of my bed or chair and move around.

You are expected to live for at least 12 more weeks.

Iodine-131 treatment did not work for me or I can't receive it.

I have not had 131I therapy in the last 6 months, or 1 month if my post-treatment scan was negative.

I haven't had 131I therapy in the last 6 months, or 4 weeks if my post-treatment scan was negative.

Cyclophosphamide

Sirolimus

This phase Ib/II trial is aimed at studying the combination of a drug named Selinexor (selective inhibitor of nuclear export) in combination with standard therapy for B cell Non-Hodgkin's lymphoma called R-CHOP. The investigators will establish maximum tolerated dose of Selinexor in combination with RCHOP and also study the efficacy of this combination for therapy of B cell Non-Hodgkin's lymphoma. Giving Selinexor plus chemotherapy may work better in treating patients with B cell non-Hodgkin lymphoma.

Selinexor Plus Combination Chemotherapy in Treating Patients With Advanced B Cell Non-Hodgkin Lymphoma

Selinexor + Chemotherapy for Non-Hodgkin's Lymphoma

This study is evaluating whether a drug may help treat Non-Hodgkin's lymphoma.

Your liver enzymes (ALT and AST) are more than 2.5 times the normal level.

If you have HIV, active hepatitis B, or active hepatitis C, you cannot participate.

Your body has too few infection-fighting white blood cells.

Your platelet count is less than 100,000 per cubic millimeter.

Your bilirubin levels in the blood are higher than normal, unless you have Gilbert's syndrome and your bilirubin levels are very high.

Your kidneys are not working well, and this is measured by a formula called the Cockroft and Gault equation.

I am mostly self-sufficient and can carry out daily activities.

I have severe allergies to the drugs used in this study.

I have newly diagnosed DLBCL or low grade B cell NHL, or it's my first relapse after non-anthracycline chemo.

I have a low-grade B cell lymphoma such as follicular, marginal zone, indolent mantle cell lymphoma, or Waldenstrom's macroglobulinemia.

I have not had major surgery within the last 2 weeks.

I have at least one tumor that can be measured, or my cancer is stage 4.

I am using effective birth control methods if I can have children.

It's been 2 weeks since my last chemo or immunotherapy, or 12 weeks since my radio-immunotherapy.

I can swallow tablets and don't have GI issues affecting medication absorption.

I have advanced B-cell NHL and R-CHOP is suitable for me.

I have DLBCL or low grade B cell lymphoma and have only used steroids for a short period.

I have low grade B cell lymphoma and have had one treatment that didn't include anthracycline.

I do not have any severe ongoing illnesses that would interfere with the study.

I have been newly diagnosed with advanced stage diffuse large B cell lymphoma.

You have a strong negative reaction to glucocorticoid medications.

My condition is either double hit or transformed diffuse large B cell lymphoma.

You are expected to live for at least 6 more months.

I have DLBCL and have had chemotherapy or immunotherapy, or I have low grade B cell lymphoma and had more than one chemotherapy or any treatment with anthracyclines.

You are currently taking any other experimental medications.

Principal Investigator

Selinexor

The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself.

A Study to Test Radium-223 With Docetaxel in Patients With Prostate Cancer

Radium-223 + Docetaxel for Prostate Cancer

This study is evaluating whether a radioactive drug may help treat prostate cancer.

I have swelling in my groin, penis, or legs due to cancer.

I haven't taken any experimental cancer treatments or other cancer therapies in the last 4 weeks.

I have severe urinary or rectal symptoms due to my cancer.

Any side effects from my previous treatments are mild.

I have had chemotherapy for prostate cancer after it became resistant to hormonal therapy.

I have undergone four or more cancer treatments for advanced prostate cancer.

I have experienced severe side effects from docetaxel.

I have not had blood transfusions or growth factors in the last 4 weeks.

I haven't taken any medications or supplements that affect PSA levels in the last 4 weeks.

You have a serious illness or medical condition that the doctor thinks would make this study too risky for you.

I have Crohn's disease or ulcerative colitis and have not had my colon removed.

I do not have an active cancer other than non-melanoma skin, non-invasive bladder cancer, or other non-invasive cancers.

I do not have any infections that are not responding to treatment.

My cancer has grown by 20% or more, or I have new cancer spots since starting treatment.

You have been diagnosed with advanced prostate cancer that is getting worse based on certain medical tests.

My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had an orchiectomy.

I have received treatment with medication targeting bones before.

I had external beam radiotherapy in the last 4 weeks.

I may have had docetaxel or abiraterone for my cancer, but it's not counted as a prior treatment line.

I do not have an active HIV, Hepatitis B, or Hepatitis C infection.

My prostate cancer diagnosis was confirmed through lab tests.

I am fully active and can carry on all my pre-disease activities without restriction.

I have at least 3 lung or liver metastases or one larger than 2 cm.

My bone disease has worsened or I have two or more new bone lesions.

My recent tests show my organs are functioning well.

I have spinal cord compression confirmed by symptoms or MRI.

Docetaxel

Radium-223

A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer (EBC)

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

Ribociclib + Endocrine Therapy for Breast Cancer

This study is evaluating whether a drug may help treat breast cancer.

I am still experiencing side effects from my previous cancer treatments.

I have finished all recommended chemotherapy before or after surgery.

I have a digestive issue that affects how my body absorbs medication.

I was diagnosed with invasive breast cancer less than 18 months ago.

I am fully active or restricted in physically strenuous activity but can do light work.

I have finished any recommended additional radiation therapy.

I can safely receive hormone therapy for my condition and will be treated for 5 years.

I have been treated with a CDK4/6 inhibitor.

I am a woman aware of my menopausal status or I am a man.

I have taken medication like tamoxifen or for osteoporosis in the last 2 years and am currently on hormone replacement therapy.

I have received high doses of specific chemotherapy drugs.

My breast cancer has spread beyond the regional lymph nodes or has come back after surgery.

I am not on any cancer treatment except for hormone therapy.

I have another cancer or was treated for one less than 2 years ago.

I am not taking any strong medication or supplements that affect enzyme CYP3A4/5.

My breast cancer is hormone receptor positive.

I have tumor tissue saved from a previous surgery.

My surgery removed the tumor completely and I am in stage II or III.

I am fully active or can carry out light work.

You are allergic to any of the ingredients in ribociclib.

I have not had major surgery or cancer treatment in the last 2 weeks.

I have taken steroids within the last 2 weeks.

I do not have uncontrolled heart problems or abnormal heart rhythms.

Endocrine Therapy

Ribociclib

This is a Phase 2, multicenter, open-label study to provide continued supply of parsaclisib as monotherapy or in combination therapy with itacitinib, ruxolitinib, or ibrutinib to participants from Incyte-sponsored studies of parsaclisib.

Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

Parsaclisib Combinations for B-Cell Cancers

This study is evaluating whether a drug may help treat a type of cancer.

I am willing and able to follow the study's schedule and treatment plans.

I can get parsaclisib alone or with other specific treatments outside a study.

You are willing to prevent pregnancy or becoming a father during the study.

My condition is stable as confirmed by my doctor.

I am benefiting from my current cancer treatment involving parsaclisib alone or with other specific drugs.

Ibrutinib

Itacitinib

Parsaclisib

University Of Michigan Cancer Center Clinical Trials 2022

RATIONALE: The herb ginger may help to reduce or prevent nausea and vomiting in patients receiving chemotherapy for cancer.

PURPOSE: This randomized phase II trial is studying how well ginger works in reducing or preventing nausea and vomiting in patients who are receiving chemotherapy for cancer.

UMCCOP 02-01 Ginger in Treating Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer

OBJECTIVES:

Primary

Compare the prevalence and severity of delayed nausea and vomiting in patients with cancer undergoing chemotherapy treated with lower-dose ginger vs higher-dose ginger vs placebo.

Secondary

Compare the prevalence and severity of acute nausea and vomiting in patients treated with these regimens.
Compare the safety of these regimens in these patients.
Determine whether patients can determine if they are receiving placebo or study drug, and by which variable (e.g., taste, smell, or decrease in nausea and vomiting).

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 3 treatment arms. Patients are stratified according to concurrent antiemetic type (5-HT_3 antagonist vs NK1 antagonist).

Arm I: Patients receive lower-dose oral ginger twice daily.
Arm II: Patients receive higher-dose oral ginger twice daily.
Arm III: Patients receive oral placebo twice daily. In all arms, treatment begins immediately after the chemotherapy treatment and continues for 3 days.

Patients are followed at 1 week.

PROJECTED ACCRUAL: A total of 180 patients (60 per treatment arm) will be accrued for this study.

Phase II Trial Of Encapsulized Ginger As A Treatment For Chemotherapy-Induced Nausea and Vomiting AKA IRB 2003-213

Serious Adverse Events (SAEs) are defined as Grade 4 or 5 (Adverse events will use the descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 2.0.) non-pulmonary toxicities.

All patients enrolled that received at least one scheduled dose.

The purpose of this study is to determine the effectiveness of etanercept in the treatment of patients with sub-acute lung injury following a bone marrow transplant. This study will also examine the toxicity of treatment with etanercept as well as whether there is an improved quality of life in these patients.

Study of Enbrel (Etanercept) for the Treatment Sub-Acute Pulmonary Dysfunction After Allogeneic Stem Cell Transplant

Lung or breathing problems can develop several months to years following a bone marrow transplant. In some cases, these breathing problems develop without any signs of germs or infection in the lungs. The name for this type of breathing problem is called "Sub-Acute Lung Injury". Sub-acute lung injury often develops many months, even years following a bone marrow transplant. It is often characterized by shortness of breath, cough, wheezing and fatigue.

Sub-acute lung injury can either lead to the formation of scar tissue in the lungs (making it difficult to take deep breaths), or it can cause the lungs to get weak (making people feel out of breath easily). Approximately 25 - 50% of patients with sub-acute lung injury may eventually die from the damage in their lungs. Typically, such patients die from infections that develop inside the damaged lungs.

In this study, treatment with an experimental drug called Etanercept will be used. (Enbrel). The physicians feel there is the possibility that Etanercept may help improve breathing. Breathing ability will be assessed prior to treatment as well as during and after treatment so that comparisons can be made.

Soluble Tumor Necrosis Factor Receptor: Enbrel (Etanercept) for the Treatment of Sub-Acute Pulmonary Dysfunction Following Allogeneic Stem Cell Transplantation. A Phase II Study