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: Interferon alfa may interfere with the growth of cancer cells.Vaccines may make the body build an immune response to kill tumor cells. It is not yet known whether melanoma vaccine plus interferon alfa is more effective than interferon alfa alone in treating patients with metastatic melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without vaccine therapy in treating patients with metastatic melanoma.

Interferon Alfa With or Without Vaccine Therapy in Treating Patients With Metastatic Melanoma

Interferon Alfa With/Without Vaccine for Skin Cancer

This study is evaluating whether interferon alfa plus a vaccine is more effective than interferon alfa alone in treating patients with metastatic melanoma.

It has been over a year since I received interferon alfa or a melanoma vaccine.

I have had surgery for cancer that spread.

I have never been diagnosed with eye melanoma.

I haven't taken corticosteroids in the last week.

I am not taking any drugs that weaken my immune system.

My kidneys are working well enough (creatinine clearance is 40 mL/min or more).

My melanoma has spread to other parts of my body.

My heart can pump blood effectively without failure.

I have no other cancers except for non-melanoma skin cancer.

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

I do not have any heart rhythm problems that cause symptoms.

I am not currently taking cytokines or levamisole.

My thyroid condition is controlled with medication.

It has been over 4 months since my last adjuvant therapy.

I can't be made cancer-free by surgery or I have chosen not to undergo surgery.

I am not currently receiving chemotherapy.

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

I have had radiation therapy for cancer that has spread.

Interferon Alfa

Melanoma Vaccine

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 recurrent or refractory head and neck cancer.

Paclitaxel in Treating Patients With Recurrent or Refractory Head and Neck Cancer

Paclitaxel for Recurrent or Refractory Head and Neck Cancer

This study is evaluating whether paclitaxel is effective in treating head and neck cancer.

My head or neck cancer has come back or is not responding to treatment.

It's been over 3 weeks since my last immunotherapy and I'm not currently on it.

My heart is generally healthy with no recent major issues.

I haven't had certain strong cancer drugs for at least 5 weeks, and other chemotherapy for 3 weeks.

I stopped hormonal therapy 3 weeks ago, but I may be taking Megace.

I haven't had radiotherapy in the last 3 weeks and none of my treatments targeted more than 30% of my bone marrow.

My kidney function is within the required range and my calcium levels are normal.

My cancer can be measured or seen on tests.

I have had chemotherapy before for my cancer that came back or spread.

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

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

My liver function tests are within normal limits.

It has been over 3 weeks since I had major surgery.

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

Paclitaxel

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

RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer and may have fewer side effects and improve recovery. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether transurethral resection plus AD 32 is more effective than transurethral resection alone for bladder cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of transurethral resection surgery followed by AD 32 with that of transurethral resection alone in treating patients who have newly diagnosed or recurrent bladder cancer.

Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer

Surgery + Chemotherapy for Bladder Cancer

This study is evaluating whether a surgery which removes the bladder is more effective than a surgery which does not remove the bladder.

I have not had chemotherapy for bladder cancer.

I have at least 2 bladder tumors that look like papillary.

I am not currently using any biological treatments for bladder cancer.

My cancer has come back, but I've never had a Tis tumor.

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

My liver function tests are within twice the normal range.

It has been over 9 months since my bladder surgery.

I have not received AD 32 therapy for my bladder cancer.

My bladder cancer is in the early or recurrent superficial stage.

AD 32

Transurethral Resection

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and specialized high-dose radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer that cannot be removed by surgery.

Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery

Chemotherapy + Radiation for Lung Cancer

This study is evaluating whether a combination of chemotherapy and radiation therapy is more effective than chemotherapy alone in treating people with non-small cell lung cancer.

I have not had radiation therapy to my chest or neck.

My cancer has not spread through my bloodstream.

My lung cancer has not returned after surgery.

I do not have fluid in my lungs, except if it's after chest surgery.

My heart rhythm is stable without any uncontrolled irregularities.

My lung cancer has not been surgically removed and is advanced but not spread far.

I am mostly able to care for myself and carry out daily activities.

I have lost less than 5% of my weight in the last 3 months.

I do not have any heart problems that cause symptoms.

I haven't had any cancer except for skin cancer in the last 3 years.

Combination Chemotherapy

Specialized High-Dose Radiation Therapy

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

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

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)

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.

I am not on any treatments that weaken my immune system.

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.

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

RATIONALE: New imaging procedures, such as whole-body MRI, may improve the ability to detect metastatic cancer and determine the extent of disease.

PURPOSE: This clinical trial is studying whole-body MRI to see how well it works compared to standard imaging procedures in detecting distant metastases in patients with solid tumors or lymphoma.

Whole-Body MRI and Conventional Imaging in Detecting Distant Metastases in Young Patients With Solid Tumors or Lymphoma

Whole-Body MRI for Metastatic Cancer

This study is evaluating whether a new imaging procedure can detect metastases in patients with cancer.

University Of Miami Clinical Trials 2022

Trials at this site

Is this your site?

Is this your site?