No Placebo-Only Group

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of gemcitabine and trastuzumab in treating patients who have metastatic cancer of the pancreas that overexpresses HER2/neu.

Gemcitabine and Monoclonal Antibody Therapy in Treating Patients With Metastatic Cancer of the Pancreas

Gemcitabine + Monoclonal Antibody for Pancreatic Cancer

This study is evaluating whether a combination of chemotherapy and a monoclonal antibody can be more effective than chemotherapy alone in treating patients with pancreatic cancer.

I have had a condition where my lymphocytes grow abnormally.

My pancreatic cancer is advanced and tests show high levels of HER2.

My cancer has spread, but the original tumor can be measured while the spread cannot.

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

My tests show high HER2 levels in my blood, but there wasn't enough tissue to test.

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

Gemcitabine

Trastuzumab

OBJECTIVES:

I. Evaluate the efficacy and toxicity of glucocerebrosidase enzyme therapy in patients with Gaucher disease.

Phase II Study of Glucocerebrosidase in Patients With Gaucher Disease

Enzyme Therapy for Gaucher Disease

This study is evaluating whether a new enzyme therapy can help people with Gaucher disease.

I have Gaucher disease confirmed by a specific test.

I have at least 3 organ systems affected by my condition.

Glucocerebrosidase

Pivotal Trial

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known if chemotherapy is more effective with or without monoclonal antibody therapy for acute myelogenous leukemia.

PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without monoclonal antibody therapy in treating patients who have refractory or relapsed acute myelogenous leukemia.

Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia

Combination Chemotherapy + Monoclonal Antibody for Acute Myeloid Leukemia

This study is evaluating whether chemotherapy with or without monoclonal antibodies is more effective for treating people with acute myelogenous leukemia.

I will use effective birth control during and for 1 month after the study.

I have a serious infection that isn't getting better with treatment.

I have been diagnosed with acute myelogenous leukemia.

My bilirubin level is above 2.0 mg/dL, not due to Gilbert's disease or leukemia.

My heart's left ventricle isn't working properly.

I haven't had recent serious heart problems.

I can perform most of my daily activities without assistance.

I do not have leukemia in my brain or spinal cord.

I do not have any other cancer that needs treatment.

My blood, liver, kidney, and heart meet the trial's health requirements.

I do not have leukemia in an advanced stage.

I am currently receiving treatment for cancer.

I do not have any serious infections that aren't controlled by medication.

Cytarabine

Daunorubicin

Monoclonal Antibody Therapy

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of chemotherapy is more effective for metastatic colorectal cancer.

PURPOSE: Phase III trial to compare the effectiveness of three chemotherapy regimens in treating patients who have metastatic colorectal cancer.

Comparison of Three Chemotherapy Regimens in Treating Patients With Metastatic Colorectal Cancer

Chemotherapy Regimens for Colorectal Cancer

This study is evaluating whether one of three chemotherapy regimens is more effective than the others.

My colon or rectum cancer has spread and cannot be cured with surgery or radiation.

My liver function tests are within the required limits.

My heart condition is stable, and I haven't had a recent heart attack.

My cancer has worsened on scans within 6 months after my last Saltz regimen treatment.

I do not have lung fibrosis or interstitial pneumonia.

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

Fluorouracil

Leucovorin Calcium

Oxaliplatin

This is a clinical research study designed to evaluate an investigational new medication called sitaxsentan for the treatment of pulmonary arterial hypertension (patients with NYHA functional class II, III or IV). The purpose of this study is to evaluate the safety and effectiveness of two different doses of sitaxsentan, compared to placebo (inactive treatment) for the treatment of pulmonary arterial hypertension. Patients who complete this trial may be eligible to take part in an extension trial (Protocol FPH01-X). Eligible patients who receive placebo in the 12-week study cross over to receive sitaxsentan for the extension trial.

Safety and Efficacy of Sitaxsentan in the Treatment of Pulmonary Arterial Hypertension

Sitaxsentan for Pulmonary Arterial Hypertension

This study is evaluating whether a medication called sitaxsentan can improve the health of people with pulmonary arterial hypertension.

I have sleep apnea that is not well-managed.

I have a history of certain heart conditions affecting the left side.

I have moderate to severe heart condition symptoms.

I have high blood pressure in the lungs due to a specific heart condition or connective tissue disease.

I have used Flolan or Tracleer in the last 30 days.

Sitaxsentan

RATIONALE: Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Histamine dihydrochloride may help interleukin-2 kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known if interleukin-2 is more effective with or without histamine dihydrochloride in treating stage IV melanoma that is metastatic to the liver.

PURPOSE: Randomized phase III trial to compare the effectiveness of interleukin-2 with or without histamine dihydrochloride in treating patients who have stage IV melanoma that is metastatic to the liver.

Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver

Interleukin-2 +/- Histamine Dihydrochloride for Skin Cancer

This study is evaluating whether interleukin-2 with or without histamine dihydrochloride is more effective in treating stage IV melanoma that is metastatic to the liver.

My liver function tests are within acceptable limits and I don't have hepatitis B or C.

My creatinine is ≤ 1.7 mg/dL and calcium is ≤ 11.5 mg/dL.

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

I haven't needed asthma treatment in 5 years and my oxygen levels are good.

I haven't had high-dose IL-2, combo immunotherapy with chemo, or low-dose IL-2 for melanoma in the last year.

I am not on long-term steroids but can use asthma inhalers, creams, or joint injections.

I haven't taken any cancer treatments, investigational drugs, or certain medications recently.

My melanoma is confirmed to be at stage IV.

I have at least one cancer spot that can be measured and was not previously treated with radiation.

My tumor is visible and measurable by scans or physical exam.

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

I have no signs of cancer spreading to my brain.

My heart is healthy with no recent heart attacks or severe heart disease.

Histamine Dihydrochloride

Interleukin-2

All Individual Drugs Already Approved

Approved for 10 Other Conditions

RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Ovarian function suppression combined with hormone therapy using tamoxifen or exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known whether suppression of ovarian function plus either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial studies ovarian suppression with either tamoxifen or exemestane to see how well they work compared to tamoxifen alone in treating premenopausal women who have undergone surgery for hormone-responsive breast cancer.

Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer

Ovarian Suppression + Tamoxifen/Exemestane for Breast Cancer

This study is evaluating whether ovarian function suppression with either tamoxifen or exemestane is more effective than tamoxifen alone in preventing the recurrence of hormone-responsive breast cancer.

My cancer has spread to distant parts of my body.

I have had cancer before, but it fits the exceptions.

My breast cancer was confirmed by a biopsy and is hormone receptor positive.

I became postmenopausal after surgery or chemotherapy.

I have noticeable cancer remaining in my underarm area.

I have had breast cancer before, either in the same or the other breast.

I have had surgery to remove both ovaries or radiation treatment on my ovaries.

I am not pregnant or breastfeeding and do not plan to become pregnant in the next 5 years.

I plan to use hormonal therapy in addition to the study treatment for the next five years.

I have been on hormone therapy for my breast cancer for over 8 months.

I was on tamoxifen or similar hormone therapy within a year before my breast cancer diagnosis.

I have received hormone therapy for breast cancer before being considered for this trial.

My estrogen levels are in the premenopausal range.

I haven't had chemotherapy and it's been less than 12 weeks since my surgery.

I finished my chemotherapy less than 8 months ago.

My cancer is only in my breast and nearby lymph nodes, with no spread elsewhere.

My breast cancer cannot be removed with surgery.

I have had surgery to remove lymph nodes or a biopsy showing no cancer in them.

I had surgery for breast cancer and no remaining signs of cancer in the area.

Exemestane

Oophorectomy

Tamoxifen

Triptorelin

The purpose of this Phase III study is to evaluate the efficacy and safety of 3APS compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer's disease.

Evaluation of 3APS in Patients With Mild to Moderate Alzheimer's Disease

3APS for Alzheimer's Disease

This study is evaluating whether a drug called 3APS is safe and effective for people with Alzheimer's disease.

I have been diagnosed with Alzheimer's disease.

I am over 50, and if female, cannot have children.

I live at home or in assisted living with a caregiver who can help me.

I do not have any uncontrolled or significant medical conditions.

I have been on a stable dose of Alzheimer's medication for at least 4 months.

I can speak and write in English, French, or Spanish.

3APS

This randomized phase III trial studies lenalidomide to see how well it works compared to a placebo in treating patients with multiple myeloma who are undergoing autologous stem cell transplant. Giving chemotherapy before a peripheral blood stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Giving lenalidomide after autologous stem cell transplant may be an effective treatment for multiple myeloma.

Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

Lenalidomide for Multiple Myeloma

This study is evaluating whether lenalidomide might be an effective treatment for multiple myeloma.

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

My lungs work well enough to breathe without symptoms.

My multiple myeloma is active and needs treatment, and I've responded to initial therapy.

I started my first cancer treatment less than a year ago.

I have collected the required number of stem cells for my treatment.

My cancer did not worsen after my first treatment, and I've had no more than two treatment plans.

I am not pregnant or nursing and will follow strict birth control measures if of childbearing age.

I have not had any blood, bone marrow, or organ transplant.

I do not have any serious infections right now.

My heart pumps well, with an ejection fraction of 40% or higher.

I have had less than a year of treatment, including specific medications.

Lenalidomide

This Western Pennsylvania-based study will (1) improve cardiovascular risk stratification to identify high-risk populations, (2) identify disparities in cardiovascular risk based on race, socioeconomic status, and geographic location, (3) evaluate mechanisms for population differences in cardiovascular risk, and (4) implement a multidisciplinary community-based intervention program to decrease cardiovascular risk in high-risk populations. These goals, which are designed to eliminate ethnic and racial health disparities, are closely tied to the National Initiative to Eliminate Racial and Ethnic Disparities in Health and the nation's health promotion and disease prevention agenda established in Healthy People 2010.

This is a prospective cohort study of 2,000 residents of the state of Pennsylvania with approximately equal representation of white and African American subjects. All participants will undergo assessments of traditional and nontraditional risk factors to identify and determine the mechanisms of population disparities in cardiovascular risk. 800 participants who are at intermediate or high risk of cardiovascular disease will be randomly assigned to either (1) usual care/"advice only"; or (2) a multidisciplinary behavioral modification program to determine the most effective approach to reduce or eliminate racial, socioeconomic and geographic disparities in cardiovascular risk. All participants will undergo long-term follow-up for cardiovascular events.

Novel Strategies for Reducing Heart Disease Risk Disparities

Lifestyle Interventions for Heart Disease Risk Reduction

This study is evaluating whether a set of activities can improve cardiovascular risk in people with dementia.

I have a health condition that may shorten my life to under 5 years.

Professor of Medicine

Exercise

Nutrition

Stress Management Counseling

usual care

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

Laboratory Biomarker Analysis

This phase I trial is studying the side effects and best dose of vorinostat when given together with temozolomide in treating patients with malignant gliomas. Drugs used in chemotherapy, such as vorinostat and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may help temozolomide work better by making tumor cells more sensitive to the drug. Giving vorinostat together with temozolomide may kill more tumor cells.

Vorinostat and Temozolomide in Treating Patients With Malignant Gliomas

Vorinostat + Temozolomide for Brain Cancer

This study is evaluating the side effects and best dose of vorinostat when given together with temozolomide in treating patients with malignant gliomas.

I have a history of cancer or blood cell disorders.

It has been at least 3 weeks since my last radiation therapy.

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

My condition worsened despite taking temozolomide.

I do not have any active infections or serious illnesses.

I have a condition that affects how drugs are broken down in my body.

I am HIV positive and on antiretroviral therapy.

My hemoglobin level is at least 10 g/dL, transfusions included.

My steroid medication dose has been stable.

I have been diagnosed with a specific type of brain tumor.

I can care for myself but may need occasional help.

My low-grade brain tumor was later found to be cancerous.

University Of Pittsburgh Clinical Trials 2022

Trials at this site

Enzyme Therapy for Gaucher Disease

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