No Placebo-Only Group

Pivotal Trial

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Vaccines may make the body build an immune response to kill cancer cells. It is not yet known which regimen of chemotherapy combined with vaccine therapy is more effective for non-Hodgkin's lymphoma.

PURPOSE: Randomized phase III trial to determine the effectiveness of combination chemotherapy followed by vaccine therapy plus sargramostim in treating patients who have stage III or stage IV non-Hodgkin's lymphoma.

Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin's Lymphoma

Chemotherapy + Vaccine Therapy for Non-Hodgkin's Lymphoma

This study is evaluating whether a combination of chemotherapy and a vaccine is more effective than chemotherapy alone.

I have not taken corticosteroids for lymphoma.

I can take care of myself and perform daily activities.

I haven't taken corticosteroids or immunosuppressants for other conditions in the last year.

I have not received antibody therapy for my lymphoma.

I have not had chemotherapy for lymphoma.

I have used corticosteroids or optical solutions before my CT scan.

My lymphoma is at an advanced stage and confirmed by a biopsy.

I've had radiation for lymphoma at no more than 2 sites.

I have at least one tumor that can be measured on scans, besides the one biopsied.

My cancer has not spread to my brain or spinal cord.

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

Chemotherapy

Sargramostim

Vaccine Therapy

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

RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment.

PURPOSE: This phase II trial is studying how well ^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.

Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

PET Imaging for Lung Cancer

This study is evaluating whether a PET scan can help doctors predict a patient's response to treatment and plan more effective treatment.

I am scheduled for combined chemotherapy and radiation treatment.

I don't plan to use biologic therapy for more than 14 weeks after my radiotherapy ends.

I don't plan to have chemotherapy for more than 14 weeks after finishing radiotherapy.

My lung cancer is confirmed to be non-small cell type.

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

My lung cancer is not the diffuse bronchoalveolar type.

I have not had radiation therapy to the chest area.

I am not currently undergoing intensity-modulated radiotherapy.

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

I have received radiotherapy of 60 Gy or more and platinum-based chemotherapy at the same time.

I haven't had any cancer in the last 3 years, except for skin cancer or early-stage cancer that hasn't spread.

I am not scheduled for surgery to remove my cancer.

I am medically fit for intensive chemoradiotherapy.

I am currently receiving or can receive standard lung cancer treatment alongside another cancer study.

Chemoradiotherapy

Fludeoxyglucose F18 Positron Emission Tomography Imaging

The purpose of this study is to determine the optimum effective dose of recombinant plasmid DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct injection catheter (Stiletto™) system needed to benefit patients with severe Angina Pectoris.

To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter

Gene Therapy for Angina

This study is evaluating whether a gene therapy can improve angina in patients.

I am eligible for standard procedures to restore blood flow.

I cannot come back for follow-up appointments.

I have severe chest pain that doesn't improve with medication.

I cannot or will not undergo heart-related tests involving catheters or nuclear methods.

My treatment areas can be safely targeted for therapy.

I have had a stroke or a mini-stroke in the last 60 days.

I have had recent issues with diabetic eye disease or wet age-related vision loss.

I am not willing to use condoms for a year after treatment.

I am not on medications that pose a high health risk.

I experience chest pain that limits my ability to exercise, but it's not heart-related.

I have uncontrolled heart rhythm problems.

I had a major heart attack within the last 60 days.

I have not had a recent heart attack or unstable chest pain.

I have a severe condition that limits my ability to exercise.

I have severe narrowing of my aortic valve or a mechanical heart valve.

I have had cancer or currently have cancer.

I felt chest pain during my exercise test.

pVGI.1(VEGF2)

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

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.

Rush University Clinical Trials 2022

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