Pivotal Trial

No Placebo-Only Group

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.

PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.

High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma

High-Dose Interferon Alfa for Melanoma

This study is evaluating whether interferon alfa can improve survival for people with melanoma.

My skin cancer is at Stage II with a thickness of 1.5-4.0 mm.

My lymph nodes do not show signs of cancer, either by clinical exam or biopsy.

My cancer is stage III with a tumor thicker than 4mm or has spread to one lymph node.

Interferon alfa-2b

Approved for 10 Other Conditions

All Individual Drugs Already Approved

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma.

PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.

Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation, Radiation Therapy, and/or Surgery in Treating Patients With Ewing's Sarcoma

Combination Chemotherapy for Ewing's Sarcoma

This study is evaluating whether a combination of chemotherapy and radiation therapy is more effective than chemotherapy alone in treating Ewing's sarcoma.

My cancer is a type of Ewing's sarcoma or related.

My disease is either operable, was operated on, needs or doesn’t need immediate radiotherapy, has spread to lungs/pleura or beyond, and it’s been less than 45 days since my definitive biopsy.

My kidney function is normal, with a filtration rate of 60 mL/min or more.

My heart functions normally, with good pumping ability.

I don't have any health or social issues that would stop me from joining the study.

Autologous Hematopoietic Stem Cell Transplantation

Busulfan

Conventional Surgery

Dactinomycin

Doxorubicin Hydrochloride

Etoposide

Ifosfamide

Melphalan

Radiation Therapy

Vincristine Sulfate

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer.

PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.

S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer

Chemotherapy for Breast Cancer

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

I have had surgery to remove breast cancer and affected lymph nodes.

I haven't had cancer in the past 5 years, except for certain skin cancers or early-stage cervical or breast cancer.

My cancer is at an early or mid-stage and can be operated on.

I know my cancer's estrogen and progesterone receptor status.

My tumor is smaller than 1 cm and doesn't meet certain criteria.

I have breast cancer in both breasts, diagnosed within a month of each other, and the more advanced tumor meets the study criteria.

My breast cancer is confirmed and not spread beyond stage III.

My tumor is larger than 2 cm or larger than 1 cm with specific features.

My cancer has not spread to my lymph nodes and my tumor is at least 1 cm with high-risk features or larger than 2 cm.

My cancer has not spread to nearby tissues.

My breast cancer has not spread to underarm or breast nodes.

My breast cancer has spread to my lymph nodes.

Cyclophosphamide

Paclitaxel

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen-deprivation therapy is more effective for prostate cancer.

PURPOSE: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer.

Prostate Radiation Therapy or Short-Term Androgen Deprivation Therapy and Pelvic Lymph Node Radiation Therapy With or Without Prostate Radiation Therapy in Treating Patients With a Rising Prostate Specific Antigen (PSA) After Surgery for Prostate Cancer

Radiation Therapy + Androgen Deprivation for Prostate Cancer

This study is evaluating whether radiation therapy is more effective than short-term androgen deprivation therapy for prostate cancer.

I have a lump in the prostate area that might indicate cancer has returned.

I received chemotherapy before or after my prostate surgery.

I have not had certain cancer treatments like cryosurgery or radiation in the pelvic area recently.

My cancer has not spread to distant parts of my body.

My prostate cancer was treated with surgery and either no lymph nodes were affected or their status is unknown.

My PSA levels are between 0.1 and 2.0 ng/mL after my prostate surgery.

My testosterone levels are within the normal range.

My cancer has not spread to my pelvic lymph nodes or any enlarged nodes have tested negative.

I am undergoing or have undergone hormone therapy for cancer.

LHRH agonist

Pelvic Lymph Node Radiation Therapy

Prostate Radiation Therapy

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

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma.

PURPOSE: This randomized phase III trial is studying radiation therapy so see how well it works when given together with or without temozolomide in treating patients with low-grade glioma.

Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma

Radiation Therapy + Temozolomide for Brain Tumor

This study is evaluating whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma.

I do not have any health conditions that would shorten my life to less than 5 years.

I haven't had treatments like radiation or chemotherapy for my brain tumor.

I have not had radiation therapy to my head that affected my brain.

It has been over 2 weeks since my last brain surgery.

I had surgery and need an MRI afterwards.

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

Your hematocrit level is equal to or greater than 30%.

Your bilirubin levels in the blood are not more than 2 times the normal limit.

Your liver enzymes (AST and ALT) should not be more than three times the upper limit of normal.

Your creatinine level in the blood is not more than 2 times the upper limit of normal.

You can have an MRI with and without a special dye.

My brain tumor is not one of the less aggressive types.

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

I don't have any health conditions that make cancer treatment riskier.

I have severe symptoms like headaches, seizures, or trouble thinking due to my condition.

My MRI shows my tumor is growing or I am 40 years or older.

I do not have any infections that aren't responding to treatment.

I can provide a tumor sample for testing.

I am under 40, have a low-grade brain tumor causing only seizures controlled by medication, and my tumor has not grown.

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

You have a certain level of white blood cells in your body.

Your white blood cell count is equal to or greater than 3,000 per cubic millimeter.

I had surgery to remove a tumor and no cancer can be seen after.

My brain tumor is a confirmed low-grade glioma.

You have to have a test that shows you are not pregnant.

3-dimensional conformal radiation therapy

Intensity-modulated radiation therapy

Temozolomide

The objective of the PORTICO pivotal IDE trial is to evaluate the safety and effectiveness of the St Jude Medical (SJM) Portico Transcatheter Heart Valve and Delivery Systems (Portico) in the treatment of severe symptomatic aortic stenosis via transfemoral and alternative delivery methods in high risk and extreme risk patients.

Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial

Portico Valve for Aortic Stenosis

This study is evaluating whether a new heart valve may help treat aortic stenosis.

I have a history of heart bypass surgery that may affect treatment access.

I have a heart valve implant or severe heart valve issues.

I have severe heart failure requiring medication or mechanical support.

My heart's pumping ability is severely reduced.

I have a heart condition that hasn't been treated but needs surgery.

My blood vessels in the hip area are not severely blocked or twisted, making it safe for certain medical procedures.

Doctors agree surgery is too risky for me due to high chances of death or serious harm.

I have severe aortic valve stenosis confirmed by an echo test within the last 60 days.

I have symptoms of aortic stenosis and my activity is somewhat to severely limited.

I'm sorry, but it seems like the criterion you provided is incomplete. Can you please provide more context or information so that I can accurately summarize the criterion for you?

My blood vessel near the shoulder is less than 6.7 inches from a specific point.

The procedure requires using a different tube to reach the blood vessel.

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

My heart valve is thickened and near the artery openings.

My aorta is heavily calcified, making certain heart procedures complicated.

You have very low levels of white blood cells, red blood cells, or platelets in your blood.

I have a thickened heart muscle, with or without blockage.

You are allergic to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix), or have a sensitivity to contrast dye that cannot be managed with medication.

I have had a stroke or a mini-stroke in the last 6 months.

I have severe kidney problems or am on long-term dialysis.

I do not have major aortic disease like large aneurysms or severe artery twists.

The angle of the right subclavian or right axillary vein is more than 30 degrees.

I have had a heart or blood vessel procedure in the last 30 days.

I have a history of bleeding or clotting disorders.

My aortic root angle is over 70°, and I am a transfemoral patient.

The distance between two specific parts in the body is less than 6 cm (2.4 inches).

The blood vessel in your arm is too narrow for the medical equipment needed for the study.

You have other health issues that make surgery too risky, with a high chance of not surviving the operation.

The angle of the left subclavian or left axillary artery is more than 70 degrees.

My aortic valve is either congenital unicuspid, bicuspid, or non-calcified.

You had a heart attack within the last 30 days.

You have signs of a mass, blood clot, or infection in your heart detected by an ultrasound.

Your doctor thinks you might not live for more than a year because of other health problems not related to your heart.

I need medication or a device to help my heart pump blood.

You have a previously implanted RIMA graft that would make it difficult to access for this study.

The distance between two specific points in the body is less than 2.8 inches.

I have severe aortic valve disease with more leakage than narrowing.

Your aortic annulus (a part of your heart) is between 19-27mm in size, as measured by a special x-ray scan called a computerized tomography (CT) within the last 12 months before you agree to join the study. If you can't have a CT scan, a 3D echo and non-contrast CT of chest and abdomen/pelvis may be accepted, but it needs approval from the subject selection committee.

Your aortic annulus does not have calcium deposits.

My heart's aortic opening is either smaller than 19 mm or larger than 27 mm.

I haven't had a stomach ulcer or upper GI bleeding in the last 3 months.

I have a condition that makes heart access through the chest difficult.

My arteries near the shoulder are very narrow or twisted.

Portico Re-sheathable Transcatheter Aortic Valve System

RATIONALE: Currently, adjuvant endocrine therapy often follows a "one-size-fits- all" approach, with most premenopausal women receiving tamoxifen, and most postmenopausal receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive lobular carcinoma are treated no differently than patients with invasive ductal carcinoma based on the void of information specific to patients with this tumor type. Identification of a biological signal of tamoxifen and/or AI-resistance and/or fulvestrant-sensitivity in ILC patients would have dramatic implications for the future management of this breast cancer subtype.

PURPOSE: To study whether fulvestrant is more effective than anastrozole or tamoxifen in reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in expression of ER and ER-regulated genes. Differential Ki67 effect in this study will serve as a surrogate for outcome of ILC patients on endocrine therapy.

Primary Objective:

To determine the change from baseline to post-treatment Ki67 values in ER-positive, HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given orally daily), or tamoxifen (20mg given orally daily).

Endocrine Response in Women With Invasive Lobular Breast Cancer

Endocrine Therapy for Breast Cancer

I have used hormone, chemo, radiation, or new treatments for my current breast cancer.

My organs and bone marrow are working well.

I do not have active hepatitis or severe liver disease.

I will have a biopsy of my breast tumor before starting the study treatment.

I can take care of myself and perform daily activities.

I have a history of bleeding easily or very low platelet counts.

I am allergic to tamoxifen, anastrozole, fulvestrant, or their ingredients.

I stopped using hormone-based contraceptives or therapy over 30 days ago.

I have a history of blood clots or uterine cancer that makes tamoxifen unsafe for me.

I have gone through menopause completely.

I do not have any uncontrolled illnesses that could affect my participation.

My breast cancer is invasive, not spread widely, hormone-sensitive, HER2-negative, and at least 1cm big.

M.D.

Anastrozole

Fulvestrant

Tamoxifen

The purpose of this study is to evaluate the efficacy and safety of imetelstat in transfusion-dependent participants with low or intermediate-1 risk myelodysplastic syndrome (MDS) that is relapsed/refractory to erythropoiesis-stimulating agent (ESA) treatment in Part 1 of the study and to compare the efficacy, in terms of red blood cell (RBC) transfusion independence (TI), of imetelstat to placebo in transfusion-dependent participants with low or intermediate-1 risk MDS that is relapsed/refractory to ESA treatment in Part 2 of the study.

An Extension Phase has been included to allow continued treatment for those subjects who are benefitting from imetelstat and to continue to evaluate the long-term safety, overall survival (OS), and disease progression, including progression to acute myeloid leukemia (AML) in transfusion-dependent participants with low or immediate-1 risk MDS that is relapsed/refractory to ESA treatment.

Study to Evaluate Imetelstat (GRN163L) in Subjects With International Prognostic Scoring System (IPSS) Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)

Imetelstat for Myelodysplastic Syndrome

This study is evaluating whether a drug called imetelstat may help treat myelodysplastic syndrome.

I haven't taken high-dose steroids or growth factors in the last 4 weeks.

I haven't taken any cancer or immune system treatments in the last 4 weeks.

You are allergic to imetelstat or any of its ingredients.

Your heart rate is either too slow (less than 50 beats per minute) or too fast (more than 100 beats per minute) when you are not active or exercising.

My family has a history of long QT syndrome.

I haven't had serious heart issues or strokes in the last year.

I have been diagnosed with MDS or MDS/MPN-RS-T by a bone marrow test in the last 12 weeks.

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

I have not used any experimental drugs or devices in the last 30 days.

I have previously been treated with drugs like azacitidine or lenalidomide.

My family has a history of sudden heart-related deaths that may be genetic.

I have had chest surgery that may affect my heart's electrical signals.

My blood pressure is controlled and does not exceed 160/100 mmHg.

My MDS is classified as low or intermediate-1 risk.

I have been treated with imetelstat before.

I needed at least 4 blood transfusions in the last 2 months due to low hemoglobin.

I have a history of a serious type of heart block.

I am not on medications that affect heart rhythm.

I have a history of significant heart rhythm problems.

UAB Clinical Trials 2022

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