No Placebo-Only Group

OBJECTIVES:

I. Evaluate the efficacy of intravenous versus oral pulse loading of clomipramine (CMI) followed by a 12-week course of maintenance therapy in patients with obsessive compulsive disorder.

Phase II Randomized Study of Intravenous Versus Oral Clomipramine in Patients With Obsessive Compulsive Disorder

Intravenous vs Oral Clomipramine for Obsessive-Compulsive Disorder

This study is evaluating whether a different way of giving a drug (intravenous vs. oral) is more effective than the standard way of giving a drug (oral).

I do not have major psychiatric or eating disorders and am not on antipsychotics or certain blood pressure medicines.

It has been over 6 weeks since I last took fluoxetine.

I have no allergies or bad reactions to clomipramine or similar depression medications.

I have never had seizures and am not at risk for them.

I don't have prostate enlargement, high eye pressure, uncontrolled thyroid issues, or significant health problems.

I have tried at least 2 different serotonin re-uptake inhibitors without success.

My thyroid medication dose has been stable for at least 3 months.

I have major depression diagnosed after my OCD, which is my main health issue.

It has been over 3 months since my last electroconvulsive or insulin shock therapy.

I do not have heart problems or high blood pressure.

I haven't taken any corticosteroids in the last 2 weeks.

I haven't taken any mental health or seizure medications in the last 2-6 weeks.

My liver tests are normal or slightly elevated, with no liver disease.

I do not have any kidney problems, like trouble urinating.

I have been diagnosed with OCD for at least a year.

I don't have anemia, leukopenia, bleeding disorders, or bone marrow issues.

Clomipramine

Pivotal Trial

The primary purpose of the study is to determine the efficacy of an investigational therapy called DCVax(R)-L in patients with newly diagnosed GBM for whom surgery is indicated. Patients must enter screening at a participating site prior to surgical resection of the tumor. Patients will receive the standard of care, including radiation and Temodar therapy and two out of three will additionally receive DCVax-L, with the remaining one third receiving a placebo. All patients will have the option to receive DCVax-L in a crossover arm upon documented disease progression. (note: DCVax-L when used for patients with brain cancer is sometimes also referred to as DCVax-Brain)

Study of a Drug [DCVax®-L] to Treat Newly Diagnosed GBM Brain Cancer

Immunotherapy with DCVax-L for Brain Cancer

This study is evaluating whether a vaccine can improve survival for people with brain cancer.

I stopped taking steroids at least 10 days before my leukapheresis.

My initial treatment was surgery to remove as much of the tumor as possible, followed by radiation and Temodar chemotherapy.

I agree not to receive certain cancer treatments except for temozolomide as per the Stupp Protocol while on DCVax-L.

My tumor sample from surgery is enough for the protein test.

I have enough DCVax-L available for treatment after it was made.

I have been diagnosed with Grade IV brain cancer in one side of my brain.

My bone marrow, liver, and kidneys are working well.

I am between 18 and 70 years old and can legally consent.

My cancer did not worsen after finishing radiation therapy.

DCVax®-L

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 study is designed to assess the survival benefit of administering PolyHeme to severely injured trauma patients in hemorrhagic shock beginning in the prehospital setting, where blood is not available, and continuing throughout a 12-hour postinjury hospital setting.

Safety and Efficacy of PolyHeme(R) in Hemorrhagic Shock Following Traumatic Injuries Beginning in the Pre-Hospital Setting

PolyHeme for Hemorrhagic Shock

This study is evaluating whether PolyHeme can improve survival in trauma patients.

I have experienced significant blood loss and shock due to trauma.

I do not wish to participate in the trial due to personal reasons.

PolyHeme

This is a 48-week study to compare TNX-355 plus OBT to placebo plus OBT in HIV subjects. You must have a stable viral load of at least 10,000 copies/ml, been treated with highly active antiretroviral therapy (HAART) for at least 6 months, be triple class experienced, and presently failing or have failed a HAART regimen. Subjects will receive infusions every week for 8 weeks, then every two weeks.

TNX-355 With Optimized Background Therapy (OBT) in Treatment-Experienced Subjects With HIV-1

TNX-355 for HIV

This study is evaluating whether TNX-355 plus OBT is more effective than placebo plus OBT in HIV subjects.

I have been treated with a monoclonal antibody before, except for HBIG or IVIG.

I have been treated with NRTI, NNRTI, and PI drugs for HIV.

I have not had any opportunistic infections in the last 3 months.

I have not been sick with fever, diarrhea, vomiting, or signs of infection in the past week.

I have HIV but only need maintenance therapy, not acute treatment.

I haven't taken any experimental drugs in the last 30 days, except for HIV treatment.

I have not been vaccinated in the last 3 weeks.

My current HIV treatment is not working or I stopped a failing HIV treatment within the last 8 weeks.

I have been on HIV treatment for at least 6 months.

My HIV is stable with a viral load under 10,000 copies/mL and I've been on consistent treatment.

My virus responds to at least one drug in my treatment plan, confirmed by a specific test.

I am currently pregnant or breastfeeding.

I haven't had immunotherapy or chemotherapy in the last 12 weeks.

I have been treated with virus or fusion entry inhibitors before.

I have previously been treated with TNX-355.

Optimized Background Therapy (OBT)

TNX-355

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 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.

Bevacizumab

Cisplatin

Docetaxel

Gemcitabine Hydrochloride

Pemetrexed Disodium

Questionnaire Administration

Vinorelbine Tartrate

This randomized phase II trial studies radiation therapy and cisplatin to see how well they work compared with radiation therapy alone in treating patients with endometrial cancer that has come back. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, 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. It is not yet known whether giving radiation therapy together with cisplatin is more effective than radiation therapy alone in treating patients with endometrial cancer.

Radiation Therapy With or Without Cisplatin in Treating Patients With Recurrent Endometrial Cancer

Radiation Therapy + Cisplatin for Endometrial Cancer

This study is evaluating whether radiation therapy and cisplatin are more effective than radiation therapy alone in treating patients with endometrial cancer.

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

My nerve damage does not significantly affect my daily activities.

I have had a stent or tube placed for my blocked ureter before joining the study.

I have not had any cancer other than non-melanoma skin cancer in the past 5 years.

My cancer has spread outside the pelvis, including to lymph nodes.

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

You are expected to live for at least 3 months.

Your blood tests must show specific levels as per CTCAE v 3.0.

My condition limits me to only taking care of myself or I am completely disabled.

I have been diagnosed with a type of endometrial carcinoma.

I have not had extensive surgery, but I am eligible if all visible cancer was removed.

I had surgery to remove a returning tumor and scans show no remaining cancer.

I have a unique kidney shape or a kidney transplant affecting radiation treatment.

I have received chemotherapy for my current cancer recurrence.

I have had radiation therapy in the vaginal, pelvic, or abdominal area.

My endometrial cancer has returned in my pelvis or vagina, with no spread outside the pelvis.

You have a history of ongoing collagen vascular disease.

I had surgery to remove my uterus, ovaries, and fallopian tubes for uterine cancer.

My cancer has not spread beyond the pelvic area.

I have had surgery to remove a significant amount of cancer from my pelvis or vagina.

I finished hormone or chemotherapy over 6 months ago and my cancer has returned since then.

3-Dimensional Conformal Radiation Therapy

Intensity-Modulated Radiation Therapy

Internal Radiation Therapy

This randomized phase III trial studies carboplatin, paclitaxel and gemcitabine hydrochloride when given together with or without bevacizumab after surgery to see how well it works in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer that has come back. Drugs used in chemotherapy, such as carboplatin, paclitaxel and gemcitabine hydrochloride 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. Immunotherapy with monoclonal antibodies, such as bevacizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab after surgery in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.

Carboplatin, Paclitaxel and Gemcitabine Hydrochloride With or Without Bevacizumab After Surgery in Treating Patients With Recurrent Ovarian, Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

Chemotherapy +/− Bevacizumab for Ovarian Cancer

This study is evaluating whether a combination of chemotherapy and bevacizumab is more effective than chemotherapy alone in treating patients with ovarian, epithelial, primary peritoneal, or fallopian tube cancer.

University Of Cincinnati Clinical Trials 2022

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