No Placebo-Only Group

Pivotal Trial

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if treatment with cisplatin plus epinephrine is effective for head and neck cancer.

PURPOSE: Randomized double-blinded phase III trial to determine the effectiveness of cisplatin plus epinephrine in injectable gel form in treating patients who have recurrent or refractory head and neck cancer.

Cisplatin Plus Epinephrine in Treating Patients With Recurrent or Refractory Head and Neck Cancer

Cisplatin + Epinephrine for Head and Neck Cancer

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

I do not have an untreated infection at the site where I will receive treatment.

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

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

I have no major history of neck artery disease from plaque buildup, radiation, or surgery.

I have no lingering side effects from previous cancer treatments.

My head or neck cancer has come back or didn't respond after treatment.

I don't have scar tissue from previous radiation without cancer growth.

My cancer can be directly injected without causing bleeding or blockage.

My doctor has identified a main treatment goal for my most problematic tumor.

My largest tumor is chosen for treatment if I have several troublesome ones.

I have chosen a tumor that bothers me the most and a goal to improve my symptoms.

My cancer has not spread to or is threatening major blood vessels.

I don't have a heart rhythm problem that could make treatment risky.

My tumor is small enough for treatment but not for measuring treatment success.

It has been over 28 days since my last cancer treatment or experimental drug use.

My cancer affects the skin, lymph nodes, under the skin, or muscles.

My largest tumor is between 0.5 and 20 cc in size.

Cisplatin

Epinephrine

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of liposomal cytarabine in treating young patients who have recurrent or refractory meningeal leukemia, lymphoma, or solid tumors.

Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors

Chemotherapy for Childhood Leukemia, Lymphoma, or Solid Cancers

This study is evaluating whether a drug can stop cancer cells from dividing.

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

My cancer has returned or is not responding to treatment and has spread to the lining of my brain or spinal cord.

My kidney function is good, with creatinine below 1.5 mg/dL.

My liver function tests are within normal limits.

I have had a condition where my lymphocytes grow abnormally.

I am not pregnant or nursing, use birth control, and don't have uncontrolled illnesses except HIV.

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

Liposomal Cytarabine

RATIONALE: 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 whether giving monoclonal antibody therapy is more effective than a placebo in treating patients with ovarian epithelial, fallopian tube, or peritoneal cancer who have responded to surgery and chemotherapy.

PURPOSE: Randomized phase II trial to study the effectiveness of monoclonal antibody therapy in treating patients with residual disease from stage III or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer following surgery and chemotherapy.

Monoclonal Antibody Therapy in Treating Patients With Residual Disease From Stage III or Stage IV Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer Following Surgery and Chemotherapy

Monoclonal Antibody Therapy for Ovarian Cancer

This study is evaluating whether monoclonal antibody therapy is more effective than a placebo in treating patients with residual disease from stage III or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer following surgery and chemotherapy.

I can take care of myself and perform daily activities.

I've had more than one chemotherapy regimen and my last treatment was less than 4 weeks ago.

I still have visible or palpable cancer after initial surgery.

I have not had radiotherapy in my abdomen area in the last 4 weeks.

My CA 125 levels were high before or at the time of my surgery.

I had surgery less than 4 weeks ago and have had more than one debulking procedure.

My ovarian, tubal, or peritoneal cancer responded completely to initial treatment.

I had immunotherapy or used mouse-derived antibodies less than 6 weeks ago.

My bilirubin levels are not more than 1.5 times the normal upper limit.

My creatinine level is 1.6 mg/dL or lower.

Monoclonal Antibody Therapy

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

OBJECTIVES: I. Determine whether testosterone normalization ameliorates muscle protein hypercatabolism by increasing net protein synthesis in men with burn injury.

II. Determine whether the effectiveness of testosterone is enhanced by stimulation of inward amino acid transport as a consequence of hyperaminoacidemia in these men.

III. Determine whether testosterone normalization during hospitalization minimizes the need for rehabilitation by increasing net protein synthesis and preserving skeletal muscle in these men.

IV. Determine whether testosterone normalization after hospital discharge and throughout convalescence increases muscle strength and lean body mass after burn injury by increasing net protein synthesis.

V. Determine whether testosterone combined with progressive resistance exercise during convalescence confers added benefits on muscle protein synthesis, and in turn, lean body mass and muscle strength in these patients.

Randomized Study of Testosterone and Progressive Resistance Exercise in Men With Burn Injury

Testosterone + Exercise for Burns

This study is evaluating whether testosterone normalization might help burn patients build muscle.

My blood pressure is controlled with one medication.

I have never had prostate cancer or signs of hidden cancer, with my PSA level below 4.0.

I have never needed treatment for heart rhythm or valve problems.

I do not have severe or unstable chest pain.

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

My heart's electrical activity is normal, without significant irregularities.

Progressive Resistance Exercise

Testosterone

OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection involving the central nervous system.

II. Determine whether neurologic outcome is improved in these patients when treated with this regimen.

III. Determine whether continuous administration of this drug suppresses recurrent skin lesions in these patients.

IV. Determine the safety of this regimen in these patients.

Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Involving the Central Nervous System

Oral Acyclovir for Herpes

This study is evaluating whether a drug called acyclovir can be used to treat babies with herpes simplex virus infections of the brain.

I am breastfeeding and have been on acyclovir, valacyclovir, or famciclovir for more than 5 days.

My infant has a herpes infection in the brain, possibly affecting other organs.

I have had a severe brain bleed in the past.

I have tested positive for herpes (HSV-1 or HSV-2) from a skin lesion or through a CSF PCR test.

My child was born to an HIV positive mother.

I do not have infections in my skin, eyes, or mouth.

My brain or spinal cord is affected by my condition.

My cancer has spread to other parts of my body.

Acyclovir

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Docetaxel and Vinorelbine Plus Filgrastim in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

Chemotherapy + Filgrastim for Advanced Lung Cancer

This study is evaluating whether a combination of chemotherapy and filgrastim can improve the survival of people with non-small cell lung cancer.

It's been over 2 weeks since my major surgery and 6 months since my heart procedure.

My lung cancer is confirmed to be at an advanced stage (IIIB or IV).

I do not have any symptoms from brain metastases.

My treatment plan does not specify endocrine therapy.

I haven't taken experimental drugs or acetaminophen for fever in the last 30 days.

I am mostly independent and can care for myself.

I am not taking any other blood cell growth boosters.

My creatinine level is 2.0 mg/dL or lower.

It's been over 2 weeks since my last radiotherapy session and I've recovered.

My heart condition is stable, and it's been over 6 months since my last heart attack.

Docetaxel

Filgrastim

Vinorelbine

Too much or too little genetic information (chromosome material) can cause abnormal development of the fetus or death. Each year approximately 2.5 million pregnant women are screened for Down Syndrome using invasive screening methods (amniocentesis or chorionic villus sampling). This 11 center study of 38,000 women will compare the accuracy of the several non-invasive tests in the first and second trimesters of pregnancy versus amniocentesis or diagnosis at birth to diagnose aneuploidy or Down Syndrome.

Down Syndrome - Comparison of Screening Methods in the 1st and 2nd Trimesters

Non-Invasive Screening Methods for Down Syndrome

This study is evaluating whether a non-invasive test can be used to diagnose Down Syndrome in the first and second trimesters of pregnancy.

I am fluent in English or have access to an interpreter.

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

This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, 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 dinutuximab, may block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.

Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma

Isotretinoin +/- Immunotherapy for Neuroblastoma

This study is evaluating whether a combination of chemotherapy, isotretinoin, dinutuximab, aldesleukin, and sargramostim is more effective than chemotherapy alone in treating patients with neuroblastoma.

My heart's pumping ability is confirmed to be normal by recent tests.

I have high-risk neuroblastoma, or it became high-risk after initial diagnosis.

I completed therapy for my cancer, including intensive treatment and a stem cell transplant.

My seizures are under control with medication and I have no severe brain-related side effects.

My parent or guardian has given written consent for me to participate.

I am eligible for a second stem cell transplant.

My latest bone marrow tests show less than 10% tumor cells before my stem cell transplant or joining this study.

I started my first chemotherapy for high-risk neuroblastoma less than 12 months ago.

I've had recent scans and tests to check my cancer's stage before joining the trial.

I've completed therapy for neuroblastoma, including intensive treatments and possibly surgery.

I am eligible for a tandem transplant and have followed specific treatment protocols within the last 12 months.

My veno-occlusive disease is stable or getting better.

My lung function tests are above 60% of what's expected, or I'm a child without breathing issues.

My neuroblastoma shows a positive response according to specific criteria before stem cell transplant.

My kidney function is within the required range for my age and gender.

I have never received GD2 antibody therapy.

I can do most activities and my doctor thinks I have at least 2 months to live.

I still have cancer after radiotherapy but haven't had a biopsy.

My neuroblastoma shows a positive response to treatment before stem cell transplant.

My kidney function is normal or near normal.

Aldesleukin

Dinutuximab

Isotretinoin

Sargramostim

The goal of the Early Treatment for Retinopathy of Prematurity Study (ETROP) is to test the hypothesis that earlier treatment in carefully selected cases will result in an overall better visual outcome than treatment at the conventional CRYO-ROP threshold point in the disease.

The Early Treatment for Retinopathy of Prematurity Study (ETROP)

Early Treatment for Retinopathy of Prematurity

This study is evaluating whether early treatment of retinopathy of prematurity (ROP) can improve vision.

My baby was born weighing less than 1251 grams and was either born at or examined by a participating center within 42 days of life.

My infant has a severe eye condition due to premature birth.

Early Treatment

Most clinicians who care for patients with inflammatory airway diseases such as allergic rhinitis and asthma are aware of the negative effects of certain sights, sounds and smells that can precipitate clinical exacerbations in certain susceptible patients. This is thought to be due to subconscious associations between these observable stimuli paired and actual exposure to allergens that induce clinical symptoms. The severity and duration of these symptoms are typically related to levels of anxiety and/or depression in affected patients. Classical conditioning of the immune response has been described in many animal and some human studies in association with administration of immunosuppressive drugs. In successfully conditioned individuals, subsequent exposure to the conditioning stimulus alone produces immunosuppressive changes similar to those caused by the drugs themselves. Since disease exacerbating conditioning appears to be prevalent in allergic patients, these conditions make an excellent human model for understanding the relationships between classical conditioning, psychological stress (particularly anxiety and depression) and immune regulation. Thus this proposal will seek to examine the hypothesis that antiinflammatory effects of pharmacotherapeutic agents can be classically conditioned and are clinically effective due to changes in immunoregulatory imbalances known to occur in patients with allergic airway diseases. The effectiveness of this therapeutic approach will be significantly affected by levels of psychological stress and individual suggestibility. This will be investigated with the following Specific Aims: (1). Determine the relative effectiveness of classical conditioning by a novel gustatory stimulus paired with immunosuppressive doses of corticosteroid on in vivo and in vitro immune responses (allergen - specific vs. general) of patients before, during and after classical conditioning correlated with level of clinical response; (2) Determine the role of neuroendocrine mechanisms (particularly catecholamines) on the inducibility and duration of the conditioned immune responses; and (3) Investigate the influence of psychological stress levels (including anxiety and depression) and/or suggestibility on baseline immune changes, success and duration of the classical conditioning.

These data will help define parameters for classical conditioning in humans, establish a model to investigate mechanisms and serve as the basis for development of future interventional protocols for severe inflammatory diseases involving classical conditioning.

Classical Conditioning to Treat Allergic Airway Diseases

Classical Conditioning for Allergic Asthma

This study is evaluating whether a novel way to permanently end chronic cluster headaches via minor surgery near your cheek bone. The aim is to address a potential pinched nerve that causes cluster headaches in some patients.

I have never tasted licorice or I do not like its taste.

Classical Conditioning

There is a need for more treatment options for patients with recurrent squamous cell cancer of the head and neck (SCCHN). These tumors usually have a variety of genetic defects that include disruption of the p53 pathway, a pathway that would ordinarily work to prevent the development of tumors. In this study the transfer of the p53 gene to tumor cells using a modified adenovirus (INGN 201) in combination with chemotherapy (cisplatin and fluorouracil) will be compared to chemotherapy with cisplatin and fluorouracil in patients who have failed surgery and radiotherapy.

Effectiveness and Safety of INGN 201 in Combination With Chemotherapy Versus Chemotherapy Alone

INGN 201 + Chemotherapy for Squamous Cell Carcinoma

This study is evaluating whether a gene therapy approach can improve the treatment of recurrent squamous cell cancer of the head and neck.

Fluorouracil

INGN 201

The purpose of the study is to determine whether T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.

Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.

T900607-Sodium for Liver Cancer

This study is evaluating whether a drug called T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.

I have severe heart issues, including weak heart pumping or chest pain.

I have not had any cancer other than skin cancer or cervical carcinoma in situ in the past 5 years.

I have had cancer spread to my brain or its coverings.

I've had treatments for liver cancer but it's been over 6 weeks since, and I have a new or growing tumor.

My liver cancer diagnosis was confirmed through tissue examination.

I have not had chemotherapy or radiotherapy for my liver cancer.

I am able to care for myself but cannot do normal activities or work.

I have a tumor that can be seen and measured on a CT scan.

I have not had major surgery in the last 4 weeks.

My liver function is classified as either good or moderately good.

T900607-Sodium

This clinical trial is to determine an effective dosage and to study the safety of an investigational drug -lidorestat (IDD-676)- which is intended to stop or slow the progression of diabetic peripheral neuropathy.

Lidorestat (IDD 676) for the Treatment of Diabetic Neuropathy

Lidorestat for Diabetic Neuropathy

This study is evaluating whether an investigational drug can help people with diabetes.

My blood pressure is not controlled by medication.

I have a history of serious kidney or liver disease.

I have Type 1 or Type 2 diabetes with mild to moderate nerve pain.

I can visit the clinic often over the next 7 months.

Lidorestat (IDD-676)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. R-flurbiprofen may be effective in delaying the recurrence of localized prostate cancer.

PURPOSE: Randomized phase II trial to study the effectiveness of R-flurbiprofen in treating patients who have localized prostate cancer at risk of recurrence following radiation therapy and/or prostatectomy.

R-Flurbiprofen in Treating Patients With Localized Prostate Cancer at Risk of Recurrence

R-Flurbiprofen for Prostate Cancer

This study is evaluating whether a drug called R-flurbiprofen can delay the recurrence of prostate cancer.

University Of Texas Clinical Trials 2022

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