No Placebo-Only Group

Pivotal Trial

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if treatment with cisplatin plus epinephrine is effective for head and neck cancer.

PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of cisplatin plus epinephrine in injectable gel form in treating patients who have recurrent or refractory head and neck cancer.

Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer

Cisplatin + Epinephrine for Head and Neck Cancer

This study is evaluating whether a combination of drugs is more effective than a single drug in treating head and neck cancer.

I do not have an untreated infection at the site where I will receive treatment.

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

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

I have no major history of neck artery disease from plaque buildup, radiation, or surgery.

I have no lingering side effects from previous cancer treatments.

My head or neck cancer has come back or didn't respond after treatment.

I don't have scar tissue from previous radiation without cancer growth.

My cancer can be directly injected without causing bleeding or blockage.

My doctor has identified a main treatment goal for my most problematic tumor.

My largest tumor is chosen for treatment if I have several troublesome ones.

I have chosen a tumor that bothers me the most and a goal to improve my symptoms.

My cancer has not spread to or is threatening major blood vessels.

I don't have a heart rhythm problem that could make treatment risky.

My tumor is small enough for treatment but not for measuring treatment success.

It has been over 28 days since my last cancer treatment or experimental drug use.

My cancer affects the skin, lymph nodes, under the skin, or muscles.

My largest tumor is between 0.5 and 20 cc in size.

Cisplatin

Epinephrine

To determine the rate of response and duration of reponse following therapy with Aroplatin in subjects with advanced colorectal cancer resistant to standard therapies. Secondary objectives are to determine safety and tolerability of the Aroplatin therapy.

A Safety and Effectiveness Study of Aroplatin in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies

Aroplatin for Advanced Colorectal Cancer

This study is evaluating whether a new chemotherapy drug called Aroplatin is safe and effective for people with advanced colorectal cancer.

I have not been treated for cancer in the last 5 years, except for cervical or non-melanoma skin cancer.

I am a woman who can have children and my pregnancy test is negative.

I am not pregnant or breastfeeding and agree to use contraception during the study.

I have been treated with oxaliplatin before.

I have cancer that has spread to my brain.

My colorectal cancer has spread and cannot be removed by surgery.

I do not have any serious infections or illnesses that are not under control.

My cancer did not respond to treatments including 5-FU, leucovorin, capecitabine, or irinotecan.

I am able to care for myself and move around.

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

My heart works well enough for daily activities without severe symptoms.

Aroplatin

This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

Vaccine Therapy for Patients With Stage III Melanoma

Vaccine Therapy for Stage III Melanoma

This study is evaluating whether a vaccine can prevent or slow the recurrence of melanoma.

All visible signs of my disease have been surgically removed.

I am not on medications or therapies that weaken my immune system.

CancerVax™ Vaccine

This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

Vaccine Therapy for Patients With Stage IV Melanoma

Cancer Vaccine for Melanoma

All visible signs of my disease were removed with surgery.

I am not on any treatments that weaken my immune system.

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

PURPOSE: This phase III trial is studying everolimus to see how well it works in treating patients with kidney cancer who have undergone surgery.

S0931, Everolimus in Treating Patients With Kidney Cancer Who Have Undergone Surgery

Everolimus for Kidney Cancer

This study is evaluating whether everolimus is effective in treating patients with kidney cancer.

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

My cholesterol is over 300 mg/dL and my triglycerides are more than 2.5 times the upper limit.

My blood sugar levels are controlled and monitored.

My kidney cancer has spread to small blood vessels but not to distant parts.

I cannot have IV iodine-based or gadolinium contrast due to health reasons.

I have no cancer history, except for certain skin cancers, early-stage cancers in remission, or any cancer I've been free from for 5 years.

I have not received any treatment for kidney cancer before.

I am not currently taking steroids or other drugs that weaken my immune system.

My condition is classified as intermediate high-risk or very high-risk.

I do not have an uncontrolled serious heart rhythm problem.

I have had surgery to remove my kidney and any affected lymph nodes.

My kidney cancer diagnosis was confirmed through lab tests.

Your ANC (absolute neutrophil count) is at least 1,500 per cubic millimeter.

I do not have severe liver disease or cirrhosis.

I haven't taken strong CYP3A4 affecting drugs in the last 14 days.

My stomach and intestines work well and don't have diseases that affect medication absorption.

I can safely receive IV iodine-based contrast or gadolinium.

My cholesterol levels are controlled and will be monitored.

Your platelet count is at least 100,000 per cubic millimeter.

Your bilirubin level in the blood is not more than 1.5 times the upper limit of normal.

Your SGOT and SGPT liver enzyme levels are not more than 2.5 times the upper limit of normal.

My kidney cancer has not spread into the wall of the renal vein.

I registered for the trial within 84 days after my first tumor surgery.

I can carry out all my usual activities without help.

My kidney function, measured by creatinine levels, is within the normal range.

I am allergic to everolimus, sirolimus, temsirolimus, or their ingredients.

I can have MRI scans if I can't have CT scans with contrast.

My cancer can be clear cell or non-clear cell type.

I have a lung condition that is not currently under control.

I haven't had a live vaccine in the last 7 days.

My blood sugar levels are not controlled and are higher than normal.

I am not currently taking any cancer treatments or experimental drugs.

My recent scans show no signs of kidney cancer after surgery.

Everolimus

This randomized phase III trial studies clofarabine to see how well it works compared with daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as clofarabine, daunorubicin hydrochloride, cytarabine, and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which chemotherapy regimen is more effective in treating acute myeloid leukemia.

Clofarabine or Daunorubicin Hydrochloride and Cytarabine Followed By Decitabine or Observation in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Chemotherapy Combinations for Acute Myeloid Leukemia

This study is evaluating whether clofarabine is more effective than daunorubicin hydrochloride and cytarabine when followed by decitabine or observation in treating older patients with newly diagnosed acute myeloid leukemia.

My kidney function is good, with a GFR of 60 ml/min or more.

I may need a spinal tap to check for brain involvement.

I have recovered from any serious infections caused by initial treatments.

I have been newly diagnosed with AML and can undergo intensive chemotherapy.

My leukemia developed from a previous blood disorder.

My white blood cell count is high enough for decitabine treatment.

I finished my last cancer treatment between 28 days and 3 months ago.

My cancer responded well to the initial treatment.

I have recovered from my recent chemotherapy.

I will start maintenance treatment within 60 days after my blood counts recover from my second consolidation cycle.

My blood tests show I am currently in remission.

My kidney function, measured by creatinine, is normal or slightly increased.

I have a matching donor for my treatment.

I have been treated for a blood disorder with specific medications.

I have a weak immune system and may react badly to strong immune treatments.

I use effective birth control methods if I am sexually active.

I have maintained my complete remission status.

I have a history of disorders related to lymphocyte proliferation.

I have provided samples for specific blood and bone marrow tests.

I am in complete remission and fit for further treatment.

My treatment started within 60 days after tests showed my cancer was responding.

I have recovered from serious infections after my second round of intensive cancer treatment.

I am currently being treated for another cancer.

I currently have an infection that isn't under control.

My leukemia is confirmed to be APL by specific genetic tests.

My leukemia has transformed into a more aggressive form.

I have been treated for MDS with specific medications before.

I have had chemotherapy for AML, but only hydroxyurea for high blast count or leukapheresis.

My cancer has spread to my brain or spinal cord.

I haven't had cancer in the last 5 years, except for skin cancer.

My bilirubin and creatinine levels are within normal limits.

I can care for myself but may not be able to do heavy physical work, especially if I'm over 70.

My heart pumps blood effectively, meeting the minimum health standard.

My lung function, specifically for absorbing gases, is above 40% and I don't have lung disease symptoms.

Clofarabine

Cytarabine

Daunorubicin

Decitabine

Approved for 10 Other Conditions

The main purpose of this study is to evaluate the efficacy and safety of ramucirumab or merestinib or placebo plus cisplatin and gemcitabine in participants with advanced or metastatic biliary tract cancer.

A Study of Ramucirumab (LY3009806) or Merestinib (LY2801653) in Advanced or Metastatic Biliary Tract Cancer

Ramucirumab/Merestinib + Chemotherapy for Biliary Tract Cancer

This study is evaluating whether a drug called ramucirumab or a drug called merestinib or a placebo plus cisplatin and gemcitabine can improve survival in people with advanced or metastatic biliary tract cancer.

My cancer is a type of biliary tract cancer that cannot be surgically removed.

I have had cancer or have another cancer besides the one being studied.

I expect to undergo a major surgery during the study.

I do not have severe health issues unrelated to my cancer that could risk my life.

My cancer is a mix of liver and bile duct types.

I have or had brain issues due to liver disease, severe fluid buildup in my abdomen, or serious liver damage.

I have not had a heart attack, stroke, or similar event in the last 6 months.

I have a history of uncontrollable blood clotting disorders.

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

I am either sterile, postmenopausal, or using effective birth control.

I have had liver and kidney issues in the last 6 months.

I am a woman who can have children and I have a negative pregnancy test.

You have had an allergic reaction or sensitivity to any part of the treatment.

My blood pressure is high (≥150/90 mm Hg) despite taking medication.

I have not had a gastrointestinal perforation or fistula in the last 6 months.

I have cancer that has spread to my brain or spinal cord.

I have not had systemic therapy for advanced or metastatic disease.

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

Merestinib

Ramucirumab

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer

Abemaciclib + Tamoxifen for Metastatic Breast Cancer

This study is evaluating whether a drug called abemaciclib can be used to treat breast cancer.

I have a history of fainting, irregular heartbeats, or sudden cardiac arrest.

I have been cancer-free from other types of cancer, except for nonmelanoma skin cancer or in-situ cervical or breast cancer, for at least 3 years.

My breast cancer is hormone receptor positive and HER2 negative.

My condition worsened after hormone therapy.

I do not have an active infection requiring IV antibiotics or a detectable viral infection.

I have been treated with medication targeting CDK4/6 for my cancer.

You have a tumor that can be measured using a specific set of guidelines called RECIST 1.1.

I have a long-term condition that causes ongoing diarrhea.

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

I've had 2 chemotherapy treatments, with 1 or 2 for advanced cancer.

I stopped my previous cancer treatments at least 3 weeks ago and have recovered from their immediate side effects.

Abemaciclib

Tamoxifen

The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

Immunotherapy + Chemotherapy for Esophageal Cancer

This study is evaluating whether a combination of two drugs can improve survival for people with esophageal cancer.

I have tested positive for hepatitis B or C.

I can walk and do light activities like housework or office work.

I have cancer in my brain or spinal cord that shows symptoms or needs treatment.

My cancer is a type of esophageal cancer called squamous cell or adenosquamous carcinoma.

My esophageal cancer is advanced, cannot be surgically removed, or treated with the intent to cure.

I do not have any serious or uncontrolled health issues or active infections.

I agree to provide a sample of my tumor tissue for the study.

Fluorouracil

Ipilimumab

Nivolumab

This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.

Participants who received at least one GM T cell infusion will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

GM T Cell Therapy Long-Term Follow-Up for Cancer

I've had a gene-modified T-cell infusion in a past Celgene study and completed the follow-up.

Gene-modified (GM) T cell therapy