No Placebo-Only Group

Pivotal Trial

RATIONALE: Patients with xeroderma pigmentosum are more likely to develop skin lesions in sun-affected areas. These skin lesions, such as actinic keratoses, can develop into skin cancer. T4N5 liposome lotion may reduce actinic keratoses or other sun-induced skin damage in patients with xeroderma pigmentosum.

PURPOSE: Randomized double-blinded phase III trial to compare treatment using T4N5 liposome lotion with treatment using placebo in reducing actinic keratoses and other sun-induced skin damage in patients with xeroderma pigmentosum.

T4N5 Liposome Lotion Compared With Placebo Lotion for Preventing Actinic Keratoses in Patients With Xeroderma Pigmentosum

T4N5 Liposome Lotion for Xeroderma Pigmentosum

This study is evaluating whether a cream can reduce the number of actinic keratoses in people with xeroderma pigmentosum.

I have had all precancerous skin spots removed.

I have been diagnosed with xeroderma pigmentosum.

I have been diagnosed with at least one actinic keratosis.

Placebo Lotion

T4N5 Liposome Lotion

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Some patients may develop a resistance to chemotherapy drugs.

PURPOSE: Phase II trial to determine the reliability of a test for measuring drug resistance to paclitaxel in patients with metastatic breast cancer.

Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer

Drug Resistance Testing for Breast Cancer

This study is evaluating whether a test can predict whether a patient will respond to chemotherapy.

I have a tumor that is larger than 1 cm or can be felt.

My metastatic breast cancer can be biopsied.

Paclitaxel

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

PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating patients with metastatic, recurrent, or unresectable cancer of the esophagus.

Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus

Paclitaxel for Esophageal Cancer

This study is evaluating whether paclitaxel is effective in treating esophageal cancer.

I haven't had chemotherapy in the last 4 weeks.

I do not have severe numbness or pain in my hands or feet.

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

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

My heart condition does not severely limit my daily activities.

I have had only one chemotherapy treatment before.

I haven't had radiotherapy in the last 4 weeks.

My cancer mainly affects my esophagus or where my stomach meets my esophagus.

I have not received treatment for cancer that has spread.

My cancer is a type of esophageal cancer that cannot be removed by surgery.

I have had only one chemotherapy or radiation treatment before surgery or additional therapy.

I had skin cancer treated with the goal of curing it.

My cervical cancer was treated with the intent to cure.

Less than 30% of my bone marrow has been exposed to radiation.

I am not currently undergoing radiotherapy.

I do not have serious heart fluid buildup or irregular heartbeat.

My cancer can be measured or seen on tests.

I do not have any serious infections or illnesses.

My stomach cancer has barely spread to the junction or lower esophagus.

My cancer has not spread to the bones only.

I haven't had immunotherapy in the last 4 weeks.

I am not currently on any immunotherapy treatments.

I am not currently receiving chemotherapy.

I haven't had hormonal therapy in the last 4 weeks.

I have not had any surgery in the last 2 weeks.

I haven't had any injected antibiotics in the last week.

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.

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

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

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have locally advanced or metastatic stomach cancer that cannot be removed during surgery.

Nitrocamptothecin in Treating Patients With Locally Advanced or Metastatic Stomach Cancer That Cannot Be Removed During Surgery

Nitrocamptothecin for Stomach Cancer

This study is evaluating whether a drug called nitrocamptothecin can help treat stomach cancer.

My cancer is in the stomach or where the stomach meets the esophagus and cannot be removed by surgery.

It's been over 4 weeks since my last chemotherapy and I've recovered.

I have not had radiation on my only cancer sign.

It's been over 4 weeks since my last radiotherapy and I've recovered.

I had minor surgery over a week ago and have recovered.

I am not taking phenytoin, phenobarbital, or any seizure prevention drugs.

I don't have bowel blockage, severe diarrhea, and can swallow.

I don't have severe heart disease and haven't had a heart attack or heart failure in the last 6 months.

My condition initially responded to treatment but has since worsened.

My lymph nodes are at least 1.5 cm big as shown by a scan.

I do not have cancer that has spread to my brain.

I am fully active or able to carry on all pre-disease activities without restriction.

My bilirubin levels are 1.5 mg/dL or lower and I don't have Gilbert's syndrome.

My kidney function is normal, and my calcium levels are not too high.

I have had only one or no prior cancer treatments with immunotherapy or chemotherapy.

I have not taken drugs like irinotecan for my condition.

I am not receiving any other chemotherapy treatments.

I haven't had radiation therapy on my pelvis or lower back.

It's been over 3 weeks since my last major surgery and I've recovered.

Nitrocamptothecin

RATIONALE: Vaccines made from a person's peripheral stem cells may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Vaccine Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Vaccine Therapy for Prostate Cancer

This study is evaluating whether a vaccine made from a person's peripheral stem cells might help treat prostate cancer.

I am continuing hormonal therapy, except for antiandrogens like LHRH.

My cancer has spread to no more than 3 places in my bones and I have few symptoms.

I have taken antibiotics for minor infections no more than twice in the last 45 days.

I have new bone pain or a new finding on a bone scan.

My prostate cancer has spread and does not respond to hormone therapy.

I haven't had radiation for cancer that has spread, including with strontium chloride Sr 89.

It has been over 4 weeks since I last took immunosuppressive medication.

I am not on any medication that affects my immune system, except for over-the-counter pain relievers, low-dose antihistamines, vitamins, or H2 blockers.

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

My kidney function is good, with creatinine levels low and no uncontrolled kidney disease.

I have no severe allergies, immune diseases, a negative TB skin test, and I am HIV negative.

My PSA levels have increased by 50% from the lowest point, confirmed twice.

My testosterone levels are low due to treatment.

My soft tissue cancer has worsened, as shown by CT or MRI.

My treatment plan for biologic therapy is not decided.

My liver functions are normal, I don't have hepatitis, and my liver disease is under control.

I haven't had chemotherapy for cancer that has spread.

I don't have spinal cord issues, serious illnesses, or recent cancers except for treated skin cancer.

Vaccine Therapy

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

PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent glioblastoma multiforme.

Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Carmustine for Glioblastoma

This study is evaluating whether carmustine is effective in treating people with glioblastoma multiforme.

My cancer has not spread into the brain's ventricular system.

I have been diagnosed with a specific brain cancer called glioblastoma.

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

I have not taken any blood thinners before.

My brain condition does not affect my main sensory or motor areas, vision, or other cranial nerves.

My tumor has a thick outer layer, even if it's partly hollow or dead inside.

My cancer has not spread to the brainstem or midbrain.

I have undergone radiotherapy at least once.

My liver function tests are within normal limits.

My kidney function tests are within the required range.

My tumor cannot be removed surgically and is round in shape.

Carmustine

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Photosensitizing drugs, such as methoxsalen, are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells. Combining chemotherapy with photodynamic therapy may be an effective treatment for cutaneous T-cell lymphoma.

PURPOSE: Randomized phase II trial to study the effectiveness of combining different doses of bexarotene with photodynamic therapy in treating patients who have stage IB or stage IIA cutaneous T-cell lymphoma.

Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma

Chemotherapy + Photodynamic Therapy for Cutaneous T-Cell Lymphoma

This study is evaluating whether a combination of chemotherapy and photodynamic therapy is effective for treating patients with cutaneous T-cell lymphoma.

I am not currently on any other cancer treatments.

It has been over 30 days since I last used cancer treatment creams.

I am not currently using any cancer-related steroid treatments.

I have never been treated with denileukin diftitox.

It has been over 30 days since I last used topical anticancer treatments.

I haven't taken high-dose vitamin A or similar drugs in the last 30 days.

I have never had uncontrolled high cholesterol.

I have never had pancreatitis or high risk for it.

I have not received interferon as a cancer treatment.

It has been over 30 days since my last skin cancer treatment with light therapy.

I am not receiving radiotherapy to my study lesions, unless my doctor decides it's necessary.

I am not using any other cancer treatments.

I am not taking any retinoid drugs, high-dose vitamin A, or beta-carotene.

My cancer has never been more advanced than stage IIA.

I have never had melanoma or invasive squamous cell carcinoma.

My skin cancer was confirmed as T-cell lymphoma in the last year.

I do not have a history of conditions like lupus, porphyria, albinism, or missing eye lenses.

I have not had any cancer treatment that affects my whole body.

I have not had chemotherapy with drugs made from plants.

I don't have any serious illnesses or infections that would stop me from joining the study.

My cancer is at an early stage (Stage IB or IIA).

My fasting triglycerides are normal, and I may be taking medication for it except gemfibrozil.

I am not taking statin and fibrate medications together.

Bexarotene

Photodynamic Therapy

RATIONALE: Drugs used in chemotherapy such as docetaxel use different ways to stop tumor cells from dividing so they stop growing or die. Oblimersen may increase the effectiveness of docetaxel by making the tumor cells more sensitive to the drug. It is not yet known if docetaxel is more effective with or without oblimersen in treating non-small cell lung cancer.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of docetaxel with or without oblimersen in treating patients who have relapsed or refractory non-small cell lung cancer that has been previously treated.

Docetaxel With or Without Oblimersen in Treating Patients With Non-Small Cell Lung Cancer

Docetaxel With/Without Oblimersen for Lung Cancer

This study is evaluating whether a drug called oblimersen can improve the effectiveness of chemotherapy for people with non-small cell lung cancer.

I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.

I am not receiving any other cancer treatments.

I have never received an organ transplant.

I have not received second-line EGFR therapy.

I have never been treated with oblimersen.

I do not have severe fluid buildup in my lungs due to lung cancer.

I am not currently receiving any experimental or cancer treatments.

My cancer can be measured and has not been treated with radiation.

I have had one chemotherapy treatment for my cancer.

I have good veins for a long-term IV treatment.

I do not have an active autoimmune disease.

I am not currently on any biologic therapy for cancer.

I have never been treated with docetaxel.

My liver functions are within normal limits and I don't have chronic hepatitis or cirrhosis.

I do not have any disabilities that would stop me from joining the study.

I am not on blood thinners, except possibly low-dose warfarin for a central line.

My condition has returned or didn't respond to treatment.

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

I do not have severe lung disease or need oxygen due to lung surgery.

I do not have HIV, active infections, or autoimmune diseases.

I do not have seizures that my medication cannot control.

I do not have any mental health conditions that would prevent me from understanding or following the study's requirements.

I have been diagnosed with non-small cell lung cancer.

Docetaxel

Oblimersen

The purpose of this phase II study is to evaluate an investigational monoclonal antibody for the treatment of glucocorticoid-refractory Graft Versus Host Disease (GVHD). Patients diagnosed with GVHD who have not responded satisfactorily to, or are intolerant of, treatment with standard agents will be considered for entry. Patients will be allowed to continue on their other immunosuppressive drugs at stable doses during the trial. The research is being conducted at up to 20 clinical research sites in the US.

Research Study of Visilizumab for Treatment of Glucocorticoid- Refractory Graft Versus Host Disease

Visilizumab for Graft-versus-Host Disease

This study is evaluating whether an investigational monoclonal antibody can be used to treat patients with glucocorticoid-refractory GVHD.

My kidney, liver, heart functions, and blood counts are within normal ranges.

I have had a bone marrow transplant from a donor.

I have symptoms like skin thickening, stiff joints, mouth sores, or diarrhea.

I have moderate to severe graft-versus-host disease.

My condition worsened or didn't improve after therapy, within 100 days post-transplant.

Visilizumab

This is a Phase 3 study in patients with melanoma that has spread to the lymph nodes (stage III), and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

Vaccine Therapy for Patients With Stage III Melanoma

Vaccine Therapy for Stage III Melanoma

This study is evaluating whether a vaccine can prevent or slow the recurrence of melanoma.

All visible signs of my disease have been surgically removed.

I am not on medications or therapies that weaken my immune system.

CancerVax™ Vaccine

This is a Phase III study in patients with melanoma that has spread to the lymph nodes and/or a distant organ, and who have had all of their cancer surgically removed. The purpose of this study is to evaluate the ability of the CancerVax™ vaccine to prevent or slow the recurrence of melanoma.

Vaccine Therapy for Patients With Stage IV Melanoma

Cancer Vaccine for Melanoma

All visible signs of my disease were removed with surgery.

MD Anderson Clinical Trials 2022

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