Pivotal Trial

No Placebo-Only Group

The purpose of this study is to compare virus response to GW433908/ritonavir (RTV) to viral response to nelfinavir (NFV) when used with abacavir (ABC)/lamivudine (3TC) in patients that have not taken antiretroviral (ART) drugs.

Comparison of GW433908/Ritonavir to Nelfinavir When Used With Abacavir and Lamivudine in Patients That Have Not Taken Antiretroviral Drugs

Antiretroviral Therapy Regimen for HIV

This study is evaluating whether a drug combination can be used to treat HIV.

You have previously participated in studies testing new treatments or medications.

I have a serious health condition like diabetes or heart disease.

I haven't had chemotherapy or radiation in the last 28 days and won't need them during the study.

I haven't taken immune-affecting or anti-HIV drugs in the last 28 days.

I do not abuse drugs or alcohol in a way that would affect my participation in the study, or I am stable on methadone.

I have had pancreatitis or hepatitis in the last 6 months.

I have received an HIV vaccine in the last 3 months.

I haven't taken certain drugs in the last 28 days and don't expect to need them during the study.

I've taken NRTI for less than 4 weeks and never taken NNRTI or PI, except possibly one dose of nevirapine during pregnancy.

I am at least 13 years old and have consent if under 18.

Abacavir

GW433908/Ritonavir

Lamivudine

Nelfinavir

RATIONALE: Naloxone may be effective in treating constipation that may be caused by opioid pain medications such as morphine.

PURPOSE: Phase III trial to determine the effectiveness of naloxone in relieving constiption in patients who are receiving opioids for chronic pain.

Naloxone in Treating Constipation in Patients Who Are Receiving Opioids for Chronic Pain

Naloxone for Opioid-Induced Constipation

This study is evaluating whether naloxone can help people with chronic pain who are constipated.

My treatment plan does not specify biologic therapy.

I have finished at least one round of chemotherapy and may continue it during the study.

I have fewer than 3 bowel movements per week and suffer from constipation not caused by opioids.

My blood cell levels have not been specified.

I am not receiving radiotherapy to my spine, abdomen, or pelvis.

I have been on a stable dose of hormonal therapy for at least 2 weeks.

My treatment plan does not specify surgery.

I do not have any mental health conditions that would stop me from participating.

I suffer from severe constipation due to my pain medication.

My diabetes or hormonal conditions are under control.

Naloxone

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients with cervical intraepithelial neoplasia.

PURPOSE: This randomized phase II trial is studying how well SGN-00101 works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.

SGN-00101 in Treating Patients With Cervical Intraepithelial Neoplasia

SGN-00101 for Cervical Dysplasia

This study is evaluating whether a drug called SGN-00101 can prevent the development of cervical cancer.

I haven't taken systemic steroids in over 30 days.

My cervical condition is confirmed as moderate or severe pre-cancer.

I do not have any infections that need treatment.

I have had skin cancer but no other types of cancer.

I am not currently on any biologic therapy.

I am not currently undergoing chemotherapy.

I do not have a blood clotting disorder that needs treatment.

I am willing to have a procedure to remove abnormal tissue.

I am not currently undergoing radiotherapy.

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

I do not have Lupus, Diabetes, Multiple Sclerosis, or Myasthenia Gravis.

I do not have a lung condition that needs treatment.

My cervical cancer lesion is visible and remained after a biopsy.

I had a thorough cervical exam after my biopsy.

I am not currently on any immunotherapy treatments.

I do not have heart problems needing treatment.

I am not receiving any other gene therapy.

SGN-00101

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

This randomized phase IIB trial studies imatinib mesylate at two different doses and dasatinib to see how well they work in treating patients with previously untreated chronic phase chronic myelogenous leukemia. Imatinib mesylate or dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia

Imatinib or Dasatinib for Chronic Myeloid Leukemia

This study is evaluating whether a drug called imatinib mesylate or dasatinib can stop the growth of cancer cells in patients with chronic myelogenous leukemia.

I haven't had major surgery in the last 28 days and have recovered from past surgeries.

My CML is in the chronic phase, confirmed by recent tests.

I can take care of myself and am up and about more than 50% of my waking hours.

My heart is healthy and I've had an ECG test in the last 42 days without major issues.

I was diagnosed with CML within the last 6 months and tested positive for the Philadelphia chromosome.

I have CML and have only been treated with hydroxyurea or anagrelide.

I haven't had chemotherapy for stem cell mobilization.

I do not have a history of serious bleeding disorders not related to my cancer.

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.

Dasatinib

Imatinib Mesylate

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

The main purpose of this study is to determine if it is possible to put into practice a cardiac screening program for survivors of Hodgkin's disease. In this study, we would also like to screen for cardiac risk factors that can be modified either through life-style changes or medications, to uncover significant abnormal heart findings in which treatments may be needed, and to see if there is a link between cardiac health and quality of life.

Cardiac Screening in Survivors of Hodgkin's Disease Treated With Mediastinal Irradiation

Cardiac Screening for Hodgkin's Lymphoma Survivors

This study is evaluating whether it is possible to put into practice a cardiac screening program for survivors of Hodgkin's disease.

My condition worsened within a year of treatment.

I have been free from cancer for more than a year.

I received treatment for Hodgkin's disease with chest radiation at Brigham and Women's Hospital or Dana-Farber Cancer Institute.

Professor of Radiation Oncology

Echo/Stress Echo

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

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 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.

Brigham And Women'S Clinical Trials 2022

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