No Placebo-Only Group

Pivotal Trial

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. It is not yet known which regimen of chemotherapy combined with vaccine therapy is more effective for non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.

Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma

Chemotherapy + Vaccine Therapy for Non-Hodgkin's Lymphoma

This study is evaluating whether a combination of chemotherapy and a vaccine is more effective than chemotherapy alone.

I have not taken corticosteroids for lymphoma.

I can take care of myself and perform daily activities.

I haven't taken corticosteroids or immunosuppressants for other conditions in the last year.

I have not received antibody therapy for my lymphoma.

I have not had chemotherapy for lymphoma.

I have used corticosteroids or optical solutions before my CT scan.

My lymphoma is at an advanced stage and confirmed by a biopsy.

I've had radiation for lymphoma at no more than 2 sites.

I have at least one tumor that can be measured on scans, besides the one biopsied.

My cancer has not spread to my brain or spinal cord.

I haven't had any cancer in the last 5 years, except for certain skin cancers or cervical pre-cancer.

Chemotherapy

Sargramostim

Vaccine Therapy

The purpose of this study is to evaluate the ability of patients treated with Rituxan® plus FavId™ and GM-CSF to mount an immune response (humoral and/or cellular) to KLH and their idiotype.

Rituxan Plus FavId (Idiotype Vaccine) for Low-grade Non-Hodgkin's Lymphoma

Rituxan + Idiotype Vaccine for Non-Hodgkin's Lymphoma

This study is evaluating whether patients treated with Rituxan® plus FavId™ and GM-CSF can mount an immune response to KLH and their idiotype.

I have not taken Fludarabine in the last 9 months.

I am able to care for myself and perform daily activities.

I am currently on medication that suppresses my immune system.

I have a serious illness that is not cancer.

My tumor can be or has been biopsied recently.

I have received a specific vaccine for my cancer before.

I have a history of lymphoma in my brain or its coverings.

My cancer did not respond or has returned after chemotherapy.

My condition worsened after initially responding to Rituxan treatment.

I have not received any treatment for my condition.

I have undergone more than 2 treatment cycles.

My condition did not improve after Rituxan treatment.

I have been in remission from another cancer for over 2 years.

My cancer can be measured after a lymph node biopsy.

My lymphoma is a low-grade type according to WHO classification.

FavId

Rituxan

The objectives of this multi-center, randomized, controlled trial are to evaluate the safety and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating factor (GM-CSF) versus best supportive care or palliative chemotherapy.

PANVAC™-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen

PANVAC™-VF Vaccine for Pancreatic Cancer

This study is evaluating whether a new cancer treatment is safe and effective.

I have received immunotherapy for my cancer.

I haven't taken any corticosteroid pills or injections in the last 28 days.

I am fully active or can carry out light work.

My cancer did not respond to a gemcitabine treatment within the last 3 months.

I have not had radiation therapy in the last 28 days.

My cancer has spread to other parts of my body.

I am over 18 and have been vaccinated against smallpox.

Granulocyte-macrophage colony-stimulating factor (GM-CSF)

PANVAC™-VF Vaccine

RATIONALE: Vaccines made from peptides may make the body build an effective immune response to kill tumor cells.

PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.

Vaccine Therapy in Treating Patients With Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

Vaccine Therapy for Lung Cancer

This study is evaluating whether a vaccine made from peptides can help treat lung cancer.

My brain metastases have been stable for 2 months and I don't need steroids or seizure meds.

My kidney function, measured by creatinine, is within normal limits.

I am HLA-A2 negative and can only join the observation group.

My lung cancer is at an advanced stage (IIIB, IV) or has come back.

My tumor is small, less than 125 cubic centimeters.

I don't have HIV, active autoimmune diseases, or allergies to the study vaccine.

My liver functions are within the required range and I don't have hepatitis B or C.

I haven't had certain cancer treatments recently and am not in another study.

RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. Vaccines made from a person's cancer cells may help the body build an effective immune response to kill cancer cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with vaccine therapy and GM-CSF may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with vaccine therapy and GM-CSF works in treating patients with indolent B-cell non-Hodgkin's lymphoma.

Rituximab, Vaccine Therapy, and GM-CSF in Treating Patients With Non-Hodgkin's Lymphoma

Rituximab + Vaccine Therapy + GM-CSF for Lymphoma

This study is evaluating whether a combination of rituximab, vaccine therapy, and GM-CSF is more effective than rituximab, vaccine therapy, and GM-CSF alone in treating patients with indolent B-cell non-Hodgkin's lymphoma

I will use birth control during and for 30 days after the study.

My lymphoma has not spread to my brain or spinal cord.

My tumor can be biopsied or there's biopsy material available for a specific vaccine preparation.

My lymphoma is not of a specific type (mantle cell, marginal zone, MALT-type, small lymphocytic, or grade 3 follicular).

I have not received any cancer treatments before.

My lymphoma is a low-grade type known as Grade 1 or 2 follicular.

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

I have not had any other cancer in the last 5 years.

I don't have any health or mental conditions that would stop me from following the study's requirements.

GM-CSF

Rituximab

All Individual Drugs Already Approved

Approved for 5 Other Conditions

The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.

Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Chemotherapy + Midostaurin for Acute Myeloid Leukemia

This study is evaluating whether midostaurin is better than chemotherapy alone for people with acute myeloid leukemia.

I developed AML as a result of treatment for another cancer.

I haven't had chemotherapy for leukemia or myelodysplasia, except in emergencies.

I am a woman who can have children and am not using two forms of birth control.

I am a man and will use a latex condom during sex while on treatment and for 12 weeks after.

I have been diagnosed with AML, not including type M3.

Cytarabine

Daunorubicin

Midostaurin

This is a global, multicenter, open-label safety extension study. Participants receiving single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study.

A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies

Trastuzumab Emtansine Safety for Cancer

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

I do not have any severe, uncontrolled illnesses.

I have not had major surgery or a serious injury in the last 28 days.

I am willing to use effective birth control during and after the study.

My cancer has worsened despite being on trastuzumab emtansine.

I was in a control group for a previous study and my condition worsened, now I can start a new treatment.

My doctor believes I could benefit from more trastuzumab emtansine treatment.

I will use condoms if my partner is pregnant.

I have not taken any experimental cancer treatments since my last study drug dose.

I haven't had serious heart issues like heart failure or a heart attack in the last 6 months.

I have completed or am continuing trastuzumab emtansine treatment within the last 6 weeks.

I have severe trouble breathing or need oxygen all the time.

Pertuzumab

Trastuzumab

Trastuzumab Emtansine

The primary purpose of this study is to measure the response rate in participants with the myeloproliferative neoplasms (MPNs), polycythemia vera (PV), essential thrombocythemia (ET), or myelofibrosis (MF) when treated with LY2784544, including those who have demonstrated an intolerance to, failure of primary response to, or have demonstrated disease progression while on ruxolitinib.

A Study of LY2784544 in Participants With Myeloproliferative Neoplasms

LY2784544 for Blood Cancer

This study is evaluating whether a drug called LY2784544 can help people with myeloproliferative neoplasms.

LY2784544

Approved for 60 Other Conditions

This phase II trial studies how well carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant works in treating patients with newly diagnosed multiple myeloma. Carfilzomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from diving. Giving carfilzomib, lenalidomide, and dexamethasone before and after stem cell transplant may kill more cancer cells

Carfilzomib, Lenalidomide, and Dexamethasone Before and After Stem Cell Transplant in Treating Patients With Newly Diagnosed Multiple Myeloma

Carfilzomib + Lenalidomide + Dexamethasone with Stem Cell Transplant for Multiple Myeloma

You have had an allergic reaction to mannitol in the past.

You are expected to live for more than 3 months.

I have Waldenstrom's macroglobulinemia or IgM myeloma.

I haven't had cancer in the last 3 years, except for certain skin, thyroid, cervix, or low-grade prostate cancers.

I do not have severe nerve pain or damage.

I haven't been in a drug study within the last 3 weeks or 5 half-lives of the drug.

I have not had major surgery in the last 3 weeks.

My blood pressure or diabetes is not well-managed.

I have not needed antibiotics or antivirals for an infection in the last two weeks.

I need procedures to remove excess fluid from my chest or abdomen.

I have been newly diagnosed with myeloma and need chemotherapy.

I've been treated for myeloma or related conditions but haven't exceeded the specified medication limits.

I haven't had radiotherapy to multiple sites or immunotherapy within the last 4 weeks.

You currently have hepatitis A, B, or C infection.

I am willing and able to undergo a stem cell transplant.

My multiple myeloma shows low or no protein markers before treatment.

I cannot take certain medications like aspirin or warfarin due to allergies or past reactions.

I cannot undergo certain hydration treatments due to existing heart, lung, or kidney conditions.

I have or might have amyloidosis in an organ.

I can take care of myself and am up and about more than half of my waking hours.

I agree to use a condom during the study and for 28 days after, even if I've had a vasectomy.

I can take aspirin or other medications to prevent blood clots.

Your bilirubin levels are within the normal range.

Your AST and ALT levels in your blood should be less than 2.5 times the upper limit of normal.

My platelet count is at least 75, without transfusions for 2 weeks.

I agree to regular pregnancy tests if I can have children.

Your kidneys work well enough to filter at least 50 milliliters of waste from your blood every minute.

Your body has enough white blood cells called neutrophils.

I haven't had a heart attack in the last 6 months and don't have severe heart issues.

Your hemoglobin level is at least 8 grams per deciliter.

If you are able to have children, you need to have 2 negative pregnancy tests before starting lenalidomide.

I cannot afford or my insurance does not cover lenalidomide.

You have a disease that can be measured before starting treatment.

Autologous Hematopoietic Stem Cell Transplantation

Carfilzomib

Dexamethasone

Lenalidomide

This study evaluates the safety of abemaciclib in combination therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, LY3023414 plus fulvestrant, pertuzumab plus trastuzumab with loperamide, or ongoing endocrine therapy) for breast cancer that has spread to other parts of the body.

A Study of LY2835219 (Abemaciclib) in Combination With Therapies for Breast Cancer That Has Spread

Abemaciclib Combination Therapy for Advanced Breast Cancer

This study is evaluating whether abemaciclib is safe when used in combination with other drugs.

I have been treated with a nonsteroidal aromatase inhibitor for my metastatic disease and may currently be on exemestane.

My cancer progressed despite treatment with CDK4/6 inhibitors and hormone therapy.

I have brain metastases treated with radiotherapy or had neurological changes within the last 14 days.

Your recent heart test showed certain abnormal results like irregular heartbeats, signs of heart problems, or a prolonged QT interval.

I have cancer that has spread to my brain and haven't had brain radiation.

I have not had a heart attack or severe heart issues in the last 6 months.

I have type 1 diabetes, had gestational diabetes, or my type 2 diabetes is well-controlled with pills.

My breast cancer is HER2 positive and has spread to other parts.

I have not had hormone therapy for my cancer, except for letrozole.

I have not had hormone therapy for my metastatic disease, except for anastrozole.

I have been treated with a nonsteroidal aromatase inhibitor for my metastatic disease.

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

I am willing to have tumor biopsies before and after the study treatment.

I stopped all breast cancer treatments 21 days ago, except for hair loss or nerve issues.

I have been treated with a nonsteroidal aromatase inhibitor for my cancer and may currently be on exemestane or exemestane + everolimus.

For parts G, H, and I, you have a disease that can be measured using a specific set of guidelines.

I've had chemotherapy for metastatic disease and my heart function is normal.

I've had chemotherapy for my metastatic disease and my heart function is normal.

My cancer can be measured or evaluated, especially in the bones.

My blood, liver, and kidney functions are all within normal ranges.

My breast cancer has spread, is worsening quickly, and is affecting my organs.

You have received certain types of medication before, depending on the part of the study.

I am post-menopausal or pre-menopausal using ovarian suppression treatment.

I may have had hormone therapy for my cancer and could be on tamoxifen now.

I have had chemotherapy for cancer that has spread, but may also have had it as part of initial treatment.

Abemaciclib

Anastrozole

Endocrine therapy

Everolimus

Exemestane

Fulvestrant

Letrozole

Loperamide

Tamoxifen

This randomized, active controlled, multicenter phase III open-label study is designed to evaluate the efficacy and safety of alectinib compared with crizotinib treatment in participants with treatment-naive anaplastic lymphoma kinase-positive (ALK-positive) advanced non-small cell lung cancer (NSCLC). Participants will be randomized in a 1:1 ratio to receive either alectinib, 600 milligrams (mg) orally twice daily (BID), or crizotinib, 250 mg orally BID. Participants will receive treatment until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study is expected to last approximately 144 months.

A Study Comparing Alectinib With Crizotinib in Treatment-Naive Anaplastic Lymphoma Kinase-Positive Advanced Non-Small Cell Lung Cancer Participants

Alectinib vs Crizotinib for Non-Small Cell Lung Cancer

This study is evaluating whether a new drug called alectinib is better than crizotinib for treating people with advanced non-small cell lung cancer.

Sarah Cannon Cancer Center Clinical Trials 2022

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