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

No Placebo-Only Group

The objectives of this multi-center, randomized, controlled trial are to evaluate the safety and efficacy of PANVAC-VF in combination with Granulocyte-macrophage colony-stimulating factor (GM-CSF) versus best supportive care or palliative chemotherapy.

PANVAC™-VF Vaccine for the Treatment of Metastatic Pancreatic Cancer After Failing a Gemcitabine-Containing Regimen

PANVAC™-VF Vaccine for Pancreatic Cancer

This study is evaluating whether a new cancer treatment is safe and effective.

I have received immunotherapy for my cancer.

I haven't taken any corticosteroid pills or injections in the last 28 days.

I am fully active or can carry out light work.

My cancer did not respond to a gemcitabine treatment within the last 3 months.

I have not had radiation therapy in the last 28 days.

My cancer has spread to other parts of my body.

I am over 18 and have been vaccinated against smallpox.

Granulocyte-macrophage colony-stimulating factor (GM-CSF)

PANVAC™-VF Vaccine

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.

I will start treatment with bevacizumab in my second cycle after surgery to reduce my tumor.

My cancer is of a specific type affecting the lining of organs.

My cancer responded completely to my initial platinum-taxane therapy.

I am currently receiving immunotherapy or radiotherapy.

I have not had radiation therapy to my abdomen or pelvis.

I have not had surgery to remove cancer that came back.

My previous cancer diagnosis fits the trial's requirements.

I have an infection that is not responding to treatment.

I haven't had cancer treatment for 6 months and my cancer hasn't worsened.

I am receiving or have received initial treatment that includes maintenance therapy after a complete response.

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

I have not had chemotherapy for any abdominal or pelvic tumor except for ovarian, fallopian tube, or primary peritoneal cancer.

I have moderate to severe numbness, tingling, or pain in my hands or feet.

I am not pregnant, nursing, or able to become pregnant without using effective birth control.

I do not have any conditions that cause serious bleeding.

I have not had major surgery, dental surgery, or significant injury recently.

I am having surgery not aimed at reducing my cancer before starting treatment.

My cancer responded completely to initial chemotherapy, with normal exams and CA125 levels.

I agree to let a random selection decide my surgery type.

I had an allergic reaction to chemotherapy but was successfully treated with a desensitization program.

My cancer has come back and can be observed.

Your disease must have at least one measurable lesion that can be accurately measured.

I do not have a history or signs of specific brain or spinal cord diseases.

I do not have any major heart conditions.

My ovarian, peritoneal, or fallopian tube cancer has come back.

Patients need to have specific blood and body chemistry levels.

I have had only one chemotherapy regimen for my condition.

I need IV fluids or nutrition due to partial bowel blockage or a tear.

I haven't had any cancer besides non-melanoma skin cancer in the last 5 years.

Bevacizumab

Carboplatin

Gemcitabine Hydrochloride

Paclitaxel

This randomized phase III trial studies chemotherapy to see how well it works with or without bevacizumab in treating patients with head and neck squamous cell carcinoma that has come back (recurrent) or that has spread to other parts of the body (metastatic). Drugs used in chemotherapy, such as docetaxel, cisplatin, carboplatin, 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. Bevacizumab may also make tumor cells more sensitive to chemotherapy and stop the growth of head and neck cancer by blocking blood flow to the tumor. It is not yet known whether combination chemotherapy is more effective when given with or without bevacizumab in treating patients with head and neck squamous cell carcinoma.

Chemotherapy With or Without Bevacizumab in Treating Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Chemotherapy + Bevacizumab for Head and Neck Cancers

This study is evaluating whether chemotherapy with or without bevacizumab is more effective in treating patients with head and neck squamous cell carcinoma.

My cancer has not caused major bleeding or required blood-thinning medication.

I have no severe allergies to docetaxel or polysorbate 80.

I have recovered from previous cancer treatments and it's been over 4 weeks since my last surgery.

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

I am not HIV-positive or not on anti-retroviral therapy.

My cancer is a type of squamous cell cancer in the head or neck, not from the skin or nasopharynx.

My head or neck cancer has returned, cannot be cured with surgery or radiation, or has spread.

I haven't had chemotherapy or targeted therapy for my recurring or spreading head/neck cancer.

My cancer progressed after 2 rounds of initial chemotherapy.

I had skin cancer or cervical cancer but was treated for it, or I've been free from any other cancer for 3 years.

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

I haven't had major heart, stroke, or serious infection issues in the past 6 months.

I haven't had any major abdominal issues like a fistula, perforation, or abscess in the last 6 months.

I've had one round of initial cancer treatment but no chemotherapy for recurrent or metastatic disease.

I finished my chemotherapy or chemoradiotherapy 4 months ago and haven't had cancer progression since.

I've had only one radiotherapy for my head or neck cancer.

I have never been treated with bevacizumab.

Cisplatin

Docetaxel

Fluorouracil

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as etoposide, carboplatin and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known which radiation therapy regimen is more effective when given together with chemotherapy in treating patients with limited-stage small cell lung cancer. This randomized phase III trial is comparing different chest radiation therapy regimens to see how well they work in treating patients with limited-stage small cell lung cancer.

Radiation Therapy Regimens in Treating Patients With Limited-Stage Small Cell Lung Cancer Receiving Cisplatin and Etoposide

Radiation + Chemotherapy for Small Cell Lung Cancer

This study is evaluating whether different radiation therapy regimens work better than others when given together with chemotherapy.

My cancer is confined to one side of my chest and has spread only to nearby lymph nodes.

I have had only one round of chemotherapy that included carboplatin or cisplatin and etoposide.

I have not had surgery to completely remove my cancer.

My lung cancer diagnosis was confirmed through lab tests.

I have a tumor that can be measured by scans.

I do not have fluid in my lungs or, if I do, it has been tested and is not cancerous.

I haven't had chemo or radiation for small cell lung cancer, except as noted before.

My kidney function, measured by creatinine levels or clearance, is within the required range.

My cancer has spread to lymph nodes above my collarbone or on the opposite side of my chest.

You have a certain type of white blood cells called granulocytes, and you need to have at least 1,500 of them in a tiny drop of blood.

Your AST (SGOT) level is not more than 2 times the upper limit of normal.

Your blood platelet count is at least 100,000 per microliter.

I have not had radiation therapy to my chest area.

I do not have cancer cells in my chest or heart fluid.

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

Your total bilirubin level is not more than 1.5 times the upper limit of normal.

Etoposide

High Radiation Dose Therapy

Standard Radiation Dose Therapy

This randomized phase III trial studies radiation therapy to see how well it works with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.

Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

Radiation Therapy + Trastuzumab for Breast Cancer

This study is evaluating whether radiation therapy is more effective with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy.

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

I have been cancer-free for over 5 years and at low risk of it coming back.

I have suspicious masses or calcifications that have not been biopsied.

My blood pressure is not controlled by medication.

My breast cancer is invasive, even if it's very small.

My DCIS is HER2-positive based on specialized testing.

I have received whole breast radiation before being considered for this study.

My surgery removed all the cancerous cells.

My cancer has spread to nearby lymph nodes.

My breast cancer is present in more than one area.

My lymph nodes are cancer-free or only microscopically affected.

I have received anthracycline chemotherapy before.

My cancer's hormone receptor status has been tested.

I had surgery to remove a non-invasive breast cancer.

My last surgery for DCIS was within the last 4 months.

I don't have any health conditions that would stop me from getting certain cancer treatments or attending follow-up visits.

I do not have heart conditions that would prevent me from taking certain cancer treatments.

Trastuzumab

Whole Breast Irradiation

All Individual Drugs Already Approved

Approved for 10 Other Conditions

This randomized phase III trial studies pelvic radiation therapy to see how well it works compared with vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with high-risk stage I or stage II endometrial cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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 pelvic radiation therapy alone is more effective than vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial cancer.

Pelvic Radiation Therapy or Vaginal Implant Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With High-Risk Stage I or Stage II Endometrial Cancer

Radiation + Chemotherapy for Uterine Cancer

This study is evaluating whether pelvic radiation therapy is better than vaginal implant radiation therapy, paclitaxel, and carboplatin in treating patients with endometrial cancer.

My endometrial cancer is stage II with cervical invasion.

Your test results need to meet specific requirements to qualify.

I have had or will have a test for cancer cells in my abdomen as per GOG guidelines.

You have endometrial cancer that fits specific criteria based on its type, size, and location. You also need to have a certain level of blood cell counts, kidney and liver function, and performance status. You must sign a consent form and allow the release of your personal health information.

You need to have at least 100,000 platelets in a small amount of your blood.

Your bilirubin level must be less than or equal to 1.5 times the upper limit of normal.

My cancer is a rare type of uterine cancer, not the common endometrial cancer.

I have had a hysterectomy and possibly removal of both ovaries and fallopian tubes.

I may consider lymph node removal in my pelvic or para-aortic area.

My surgery can be done through a large incision or small incisions, depending on my surgeon's choice.

My cancer stage was determined using the FIGO 2009 system.

My cancer is confined to the uterus and has a specific cell type, with no cancer cells found in my abdomen.

My kidney function test shows I can clear more than 50 mL/min.

My nerve damage does not significantly affect my daily activities.

I've had a CT/MRI showing no signs of cancer spread if I didn't have certain surgeries.

My surgery can be open or minimally invasive, and it must be documented if lymph nodes were removed.

I have had a hysterectomy, and removal of both ovaries is highly recommended.

I am 18 or older and have 3 risk factors.

I have had radiation therapy for cancer in my abdomen or pelvis.

My cancer has spread beyond my uterus and cervix.

I cannot receive radiation therapy to my pelvis due to health reasons.

I have had non-surgical treatment for endometrial cancer.

My endometrial cancer is at an advanced stage (III or IV).

I am 70 or older with at least one risk factor or 50 or older with two risk factors.

You have signs of cancer spread in your lymph nodes or other parts of the body as seen in imaging tests.

I have not had any cancer except for non-melanoma skin cancer in the last 5 years.

My cancer is a specific type of endometrial carcinoma and fits certain risk categories.

My doctor took a sample from my abdomen to check for cancer.

Your alkaline phosphatase blood levels must not be more than 2.5 times the upper limit of normal.

I had a CT or MRI if I didn't have certain ovarian or lymph node surgeries.

You must have enough white blood cells called neutrophils.

Your blood creatinine level must be within the normal range for the hospital or clinic where the study is taking place.

Your SGOT level in the blood should be no more than 2.5 times the usual upper limit.

My cancer is aggressive or has spread to nearby vessels or deep into the muscle.

Pelvic Radiation Therapy

Vaginal Implant Radiation Therapy

Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving radiation with concomitant and adjuvant temozolomide versus radiation with adjuvant PCV is more effective in treating anaplastic glioma or low grade glioma.

Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma

Radiation and Temozolomide vs. PCV Chemotherapy for Brain Tumor

This study is evaluating whether radiation therapy with chemotherapy is more effective than radiation therapy alone in treating brain tumors.

I am of childbearing age and not willing to use birth control.

I have a serious condition that weakens my immune system, not caused by steroids.

I am HIV positive and currently on retroviral therapy.

My brain tumor is grade II or III with specific genetic changes.

My brain tumor is a mixed glioma with specific genetic features (1p and 19q co-deletion).

My low-grade brain tumor is considered high-risk.

I have had radiation or chemotherapy for brain cancer before.

I was diagnosed with my condition less than 3 months ago.

I have had a heart attack in the last 6 months or need ongoing treatment for heart failure.

I agree to provide tissue samples for review after my surgery.

My tumor has specific genetic changes, 1p/19q co-deletion and IDH mutation.

My tumor has a specific genetic feature (loss of parts of chromosomes 1p and 19q).

I am not pregnant or have confirmed it with a test.

I am willing to undergo tests, provide tissue samples, and return for follow-ups.

I had surgery over 2 weeks ago and have recovered well.

I do not have severe illnesses that would prevent me from joining the study.

I have had hepatitis or am at high risk of its reactivation.

I have not had another cancer besides this one in the last 5 years.

Temple University Clinical Trials 2022

Trials at this site

Is this your site?

Is this your site?