No Placebo-Only Group

The purpose of this phase II study is to evaluate an investigational monoclonal antibody for the treatment of glucocorticoid-refractory Graft Versus Host Disease (GVHD). Patients diagnosed with GVHD who have not responded satisfactorily to, or are intolerant of, treatment with standard agents will be considered for entry. Patients will be allowed to continue on their other immunosuppressive drugs at stable doses during the trial. The research is being conducted at up to 20 clinical research sites in the US.

Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease

Visilizumab for Graft-versus-Host Disease

This study is evaluating whether an investigational monoclonal antibody can be used to treat patients with glucocorticoid-refractory GVHD.

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

I have had a bone marrow transplant from a donor.

I have symptoms like skin thickening, stiff joints, mouth sores, or diarrhea.

I have moderate to severe graft-versus-host disease.

My condition worsened or didn't improve after therapy, within 100 days post-transplant.

Visilizumab

RATIONALE: Drugs used in chemotherapy, such as pixantrone, cytarabine, methylprednisolone, and cisplatin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed aggressive non-Hodgkin's lymphoma.

Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse

Chemotherapy Combination for Non-Hodgkin's Lymphoma

This study is evaluating whether a combination of drugs can improve the survival of people with aggressive non-Hodgkin's lymphoma.

My cancer worsened only once after responding to chemotherapy.

I have a history of lymphoblastic lymphoma or mantle cell lymphoma.

My condition did not improve after chemotherapy.

My creatinine level is 1.5 mg/dL or lower.

My cancer is only in my bone marrow and does not have a measurable tumor.

My liver function tests are within the required limits.

I am fully active or able to carry out light work.

My lymphoma is aggressive and confirmed by a biopsy.

My heart functions well, with no recent heart attacks or severe irregular heartbeats.

Cisplatin

Cytarabine

Methylprednisolone

Pixantrone

RATIONALE: Vaccines made from a patient's dendritic cells may make the body build an immune response to kill tumor cells. It is not yet known whether combining vaccine therapy with either gp100 antigen or the patient's tumor cells will cause a stronger immune response and kill more tumor cells.

PURPOSE: This randomized phase II trial is studying vaccine therapy and gp100 antigen to see how well they work compared to vaccine therapy and patient's tumor cells in treating patients with stage III or stage IV melanoma.

Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma

Vaccine Therapy for Melanoma

This study is evaluating whether a vaccine made from a patient's dendritic cells can help treat melanoma.

I haven't had melanoma vaccine therapy or immunotherapy in the last 6 weeks.

I have not had chemotherapy for metastatic melanoma.

My melanoma is not located in mucosal or ocular areas.

I am fully active or can carry out light work.

It has been over 6 weeks since my last radiotherapy session.

I don't have an active infection, significant autoimmune or immune deficiency disorder, and I am HIV negative.

I am not currently taking any corticosteroids.

My surgery status is not relevant for this trial.

My cancer cells are gp100 positive and I have the HLA-A201 gene.

My tumor can be surgically removed and is larger than 2 cm.

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

My skin cancer is confirmed as melanoma under a microscope.

My stage III cancer cannot be surgically removed and there's no definitive treatment for it.

Autologous Dendritic Cell-Tumor Fusion Vaccine

gp100 Antigen

Therapeutic Autologous Dendritic Cells

Pivotal Trial

This randomized phase III trial studies oxaliplatin, leucovorin calcium, fluorouracil, and bevacizumab to see how well they work compared to oxaliplatin, leucovorin calcium, and fluorouracil in treating patients who have undergone surgery for stage II colon cancer. Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, 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. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving combination chemotherapy together with bevacizumab is more effective than combination chemotherapy alone in treating colon cancer.

Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Bevacizumab in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer

Chemotherapy +/− Bevacizumab for Stage II Colon Cancer

This study is evaluating whether a combination of chemotherapy and bevacizumab is more effective than chemotherapy alone in treating patients who have undergone surgery for stage II colon cancer.

I have had a condition where my lymphocytes multiply unusually.

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

I have a tumor sample available for specific genetic testing.

I have not had a heart attack or unstable angina in the last year.

I have symptoms related to poor blood flow in my limbs.

I do not have more than one tumor at the same time.

My lab tests for Step 2 were done within the last 2 weeks.

I have not had a stroke or mini-stroke in the last year.

I do not have symptoms from peripheral vascular disease.

My cancer has spread to the mesentery but without clear lymph node involvement.

I have had radiation therapy to my pelvic area before.

I haven't had significant bleeding unrelated to my colon cancer in the last 6 months.

I have a serious or non-healing wound, skin ulcer, or bone fracture.

I am currently experiencing significant nerve pain or tingling.

I have not had any major surgeries or procedures recently.

My tumor is located at least 12 cm from the anal opening, as confirmed by a doctor.

My colon cancer is confirmed to be Stage II adenocarcinoma.

I have hereditary non-polyposis colorectal cancer.

I have never had inflammatory bowel disease.

I have never had cancer spread to distant parts of my abdomen.

My surgery removed all visible cancer without leaving any behind.

I haven't started any treatment for my cancer.

I have not had a complete blockage or tear in my intestines.

I do not have another type of cancer besides the one being treated.

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

I will start treatment between 28 and 60 days after my surgery.

I do not have any health conditions that would prevent me from taking the study drugs.

I have a history of high blood pressure that doesn't meet certain criteria.

Bevacizumab

Fluorouracil

Laboratory Biomarker Analysis

Leucovorin Calcium

Oxaliplatin

All Individual Drugs Already Approved

Approved for 5 Other Conditions

This randomized phase II trial studies how well bortezomib works when given after combination chemotherapy, rituximab, and an autologous stem cell transplant in treating patients with mantle cell lymphoma. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy 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) together with an autologous stem cell transplant may allow more chemotherapy to be given so that more cancer cells are killed. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving bortezomib after combination chemotherapy, monoclonal antibody therapy, and an autologous stem cell transplant may kill any remaining cancer cells or keep the cancer from coming back.

Bortezomib After Combination Chemotherapy, Rituximab, and an Autologous Stem Cell Transplant in Treating Patients With Mantle Cell Lymphoma

Bortezomib for Mantle Cell Lymphoma

This study is evaluating whether bortezomib works better than a placebo when given after combination chemotherapy, rituximab, and an autologous stem cell transplant in treating patients with mantle cell lymphoma.

It has been over 3 weeks since my last chemotherapy session.

My lymphoma has specific markers and I've had the required tests.

My diagnosis was confirmed through blood tests or bone marrow biopsy.

My lymphoma is at any stage, but if it's nodular, it's stage III or IV. I don't have active brain disease.

I have hepatitis B or C but my liver function is relatively normal and I don't have severe liver damage.

I do not have an active cancer other than non-melanoma skin cancer.

I have had no or just one round of chemotherapy or rituximab.

My total bilirubin level is 2.0 mg/dL or less, not due to Gilbert's Disease.

You are not allergic to products derived from mice.

I do not take corticosteroids regularly for any condition.

I have not had radiation therapy for mantle cell lymphoma.

It has been more than 2 weeks since I had major surgery.

Bortezomib

This randomized phase III trial studies the best individual therapy for women who have node-negative, estrogen-receptor positive breast cancer by using a special test (Oncotype DX), and whether hormone therapy alone or hormone therapy together with combination chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25. Estrogen can cause the growth of breast cancer cells. Hormone therapy may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. Drugs used in chemotherapy 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 hormone therapy together with more than one chemotherapy drug (combination chemotherapy) has been shown to reduce the chance of breast cancer recurrence, but the benefit of adding chemotherapy to hormone therapy for women with node-negative, estrogen-receptor positive breast cancer is small. New tests may provide information about which patients are more likely to benefit from chemotherapy.

Hormone Therapy With or Without Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Negative Breast Cancer (The TAILORx Trial)

Hormone Therapy + Chemotherapy for Breast Cancer

This study is evaluating whether hormone therapy alone or hormone therapy together with chemotherapy is better for women who have an Oncotype DX recurrence score of 11-25.

I am receiving treatment for chronic obstructive pulmonary disease.

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

I had an Oncotype DX test, but my recurrence score wasn't between 11-25.

My cancer is positive for estrogen and/or progesterone receptors.

I have heart issues that prevent me from using certain cancer drugs.

I have had surgery that meets the trial's requirements.

I haven't had chemotherapy or radiation for my cancer.

My tumor is between 5 mm and 5 cm, possibly with aggressive features.

My doctor and I agree to start standard chemotherapy and hormonal therapy after surgery.

I have a breast cancer tissue sample ready for testing.

I have been cancer-free from any previous cancers for at least 5 years.

Anastrozole

Combination Chemotherapy

Exemestane

Letrozole

Tamoxifen Citrate

This randomized phase III trial studies chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy 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 more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab also may stop the growth of non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.

Chemotherapy With or Without Bevacizumab in Treating Patients With Stage IB, Stage II, or Stage IIIA Non-small Cell Lung Cancer That Was Removed By Surgery

Chemotherapy + Bevacizumab for Non-Small Cell Lung Cancer

This study is evaluating whether chemotherapy and bevacizumab are more effective than chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery.

Your SGPT (ALT) level in the blood is less than 5 times the upper limit of normal.

I had surgery to remove my lung cancer, which was not a minor procedure, and had specific lymph nodes checked.

Your total bilirubin level must be less than or equal to 1.5 mg/dL.

I haven't had hormone or radiation cancer treatments in the last 5 years.

Your prothrombin time/international normalized ratio (INR) should be 1.5 or less.

My blood clotting time is within the normal range, or if I'm on blood thinners, it's not more than 1.5 times the upper limit.

I am not currently coughing up a significant amount of bright red blood.

I have had heart issues but have been symptom-free for over a year.

You must have a certain amount of a type of white blood cell called neutrophils in your blood.

Women who could become pregnant must take a blood or urine test to make sure they are not pregnant before joining the study.

I haven't had any cancer in the last 5 years, except for cervical in-situ carcinoma or non-melanoma skin cancer that was fully removed.

My blood pressure is under control and below 150/90.

I am on a stable blood thinner regimen or using it for DVT prevention.

I am taking aspirin or NSAIDs daily, but not dipyridamole, ticlopine, clopidogrel, or cilostazol.

I am eligible for pemetrexed/cisplatin therapy.

My lung cancer is not of the squamous cell type.

My kidney function is good, as shown by recent tests.

My blood clotting time is within safe limits while on blood thinners.

Your SGOT (AST) levels are not more than 5 times the upper limit of normal.

I had lung surgery between 6 to 12 weeks ago and have recovered well.

Your kidney function, as measured by a blood test for creatinine, is within a certain range.

I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last month.

I am not expecting to undergo any major surgeries during the study.

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

I have never had a stroke or a mini-stroke.

My urine protein levels are low enough for me to join.

I have never had chemotherapy, except possibly low-dose methotrexate for a non-cancer condition.

I haven't had major surgery, serious injuries, or biopsies recently.

I don't have any serious infections, heart issues, or other conditions that would stop me from following the study's requirements.

You are allergic to Chinese hamster ovary cell products or other similar medicines made from living cells.

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

Docetaxel

Gemcitabine Hydrochloride

Pemetrexed Disodium

Questionnaire Administration

Vinorelbine Tartrate

This randomized phase III trial studies lenalidomide, dexamethasone, and bortezomib to see how well it works compared to dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma. 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, by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the cancer. It is not yet known whether lenalidomide and dexamethasone is more effective with or without bortezomib in treating multiple myeloma.

Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previously Untreated Multiple Myeloma

Lenalidomide + Dexamethasone +/- Bortezomib for Multiple Myeloma

This study is evaluating whether lenalidomide, dexamethasone, and bortezomib is more effective than dexamethasone and lenalidomide alone in treating patients with previously untreated multiple myeloma.

My bone marrow is heavily affected by cancer, with over half of the cells being cancerous.

I do not have severe heart issues, recent heart attack, uncontrolled infections, high blood pressure, or diabetes.

My multiple myeloma does not produce detectable markers, but my serum Freelite levels are high.

I do not have a performance status of 3 due to other health conditions.

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

I have treated any fractures, pneumonia, or blood thickness issues before joining.

I can take aspirin daily or a substitute if I'm allergic.

I have no cancer history, except for certain skin cancers or in situ cervical cancer, and have been cancer-free for 5 years if I had another type.

I agree to participate in genetic testing for my cancer treatment.

I have had a stroke and still experience its effects.

You cannot have hepatitis B, hepatitis C, or HIV.

I haven't had radiation to more than half of my pelvis.

I have never had a stroke that left me with lasting brain damage.

My kidney function is good, with a creatinine clearance over 30 cc/min.

I have not received chemotherapy for my current illness.

I have been recently diagnosed with multiple myeloma and it can be measured.

I have never been treated with bortezomib or lenalidomide.

I do not have severe heart issues, uncontrolled infections, or poorly managed diabetes.

Women able to have children must have a negative pregnancy test within two weeks before starting treatment with lenalidomide.

I've had specific X-rays of my skull, chest, and pelvis within the last 28 days.

Your platelet count is at least 80,000 per microliter.

My hemoglobin level is 9 g/dL or higher, even after treatments like transfusions or EPO.

Your white blood cell count is at least 1000 per microliter.

My multiple myeloma does not show up in standard blood or urine tests.

Dexamethasone

Lenalidomide

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.

Dana Farber Clinical Trials 2022

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