
A Phase II Study of Sirolimus and Erlotinib in Recurrent/Refractory Germ Cell Tumors
Relapsed / Recurrent Germ Cell TumorsThe purpose of this study is to find out if the combination of an mTOR inhibitor (sirolimus) with an EGFR inhibitor (erlotinib) is effective at treating relapsed or refractory germ cell tumors, and to find out what the side-effects of this regimen are.

Paclitaxel and Ganetespib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary...
Recurrent Fallopian Tube CancerRecurrent Ovarian Epithelial Cancer1 moreThis phase I/II trial studies the side effects and best dose of ganetespib when given together with paclitaxel and to see how well they work in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel and ganetespib may be an effective treatment for ovarian, fallopian tube, or primary peritoneal cancer.

Cetuximab + Taxotere With Low Dose Fractionated Radiation for Head and Neck Carcinoma
Squamous Cell CarcinomaHead and Neck Cancer1 moreWhether low-dose radiation in addition to Taxotere and Erbitux improves the response rate of patients with recurrent unresectable head and neck squamous cell carcinoma.

Biomarker-Driven Therapy Using Immune Activators With Nivolumab in Patients With First Recurrence...
GlioblastomaGlioblastoma MultiformeThis research is being done to test if it is safe to give nivolumab with targeted immunotherapy drugs for recurrent glioblastoma (GBM), a type of brain tumor. The study doctors believe that giving immunotherapy drugs that match the biomarkers in a tumor will help the immune system fight the tumor. Tumor tissue collected during surgery will be tested for certain biomarkers to determine which immunotherapy might best target the tumor. The combination immunotherapy arms include: Arm A: Nivolumab + anti-GITR Arm B: Nivolumab + IDO1 inhibitor Arm C: Nivolumab + Ipilimumab

Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Blastic Plasmacytoid Dendritic Cell NeoplasmHepatosplenic T-Cell Lymphoma18 moreThis phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.

Penn Microbiome Therapy for Recurrent Clostridium Difficile Infection
Recurrent Clostridium Difficile InfectionThis is a randomized, open label, comparative, Phase II study to determine which dose of fecal microbiota transplant using Penn Microbiome Therapy (PMT) products is most effective in treating and preventing recurrence of Clostridium difficile infection (C diff).

The Safety and Antitumor Activity of the Combination of Oregovomab and Hiltonol in Recurrent Advanced...
Cancer of OvaryNeoplasms5 moreThis is a Phase Ib study to look at the combination of an antibody immunization vaccine strategy using oregovomab and an investigational stage immune booster (poly ICLC / Hiltonol), both of which have previously been used in combination with other cancer treatments and demonstrated to be active in advanced cancer, but which have not previously been used together. This study will assess the approach as to whether these two drugs can safely add to the response seen with either drug alone, both of which have doses that are based on prior studies. Subjects with stable disease for whom a 12 week break from therapy for their persistent and progressive advanced ovarian cancer is appropriate, who have signed informed consent and for whom baseline clinical information is completed, will receive 4 cycles of oregovomab/Hiltonol immunization every three weeks (weeks 0, 3, 6, and 9). Blood will be obtained for to look for a CA125 specific T cell response at 12 weeks before initiating any additional therapy according to the best clinical judgment of the investigator. At week 16 the subjects will receive a final dose of the combination of oregovomab/Hiltonol and at week 17 will have an additional blood draw for analysis of T-cell response.

Immunotherapy With Autologous Tumor Lysate-Loaded Dendritic Cells In Patients With Recurrence Of...
GlioblastomaRationale of the Study: Treatment for GBM currently consists of surgical resection of the tumour mass followed by radio- and chemotherapy. Nonetheless overall prognosis still remains bleak, recurrence is universal, and recurrent GBM patients clearly need innovative therapies. Dendritic cells (DC) immunotherapy could represent a well-tolerated, long-term tumour-specific treatment to kill all (residual) tumour cells which infiltrate in the adjacent areas of the brain. Preclinical investigations for the development of therapeutic vaccines against high grade gliomas, based on the use of DC loaded with a mixture of glioma-derived tumor have been carried out in rat as well as in mouse models, showing the capacity to generate a glioma-specific immune response. Mature DC loaded with autologous tumor lysate have been used also for the treatment of patients with recurrent malignant brain tumors; no major adverse events have been registered. Results about the use of immunotherapy for GBM patients are encouraging, but further studies are necessary to find out the most effective and safe combination of immunotherapy with radio- and chemotherapy after exeresis of the tumour mass. Aim of the study: Primary objective of the study is to evaluate treatment tolerability and to get preliminary information about efficacy. Secondary objective is to evaluate the treatment effect on the immune response. Additional objective is to identify a possible correlation between methylation status of the MGMT promoter and tumor response to treatment. A two-stage Simon design will be considered for the study. The primary objectives of the study include the evaluation of a PFS6 rate in treated patients. Assuming as outcome measure the percentage of PFS6 patients and of clinical interest an increase to 35% (P1) of the historical control response rate of 20% (P0), the null hypothesis will be rejected (a=0.05, b=0.2) at the end of the first stage if the response rate will be 5/22 treated patients (Fisher's exact test). In the second stage patients will be enrolled up to 72 overall. The study will be successful if at least 19 subjects out of 72 have PFS6 months after the beginning of the treatment.

Capecitabine and Temozolomide for Treatment of Recurrent Pituitary Adenomas
Recurrent Pituitary AdenomasThis is an open label study to assess the efficacy of capecitabine (CAP) and temozolomide (TMZ) in recurrent pituitary adenomas. There will be a safety run-in of at least three patients to establish any dose limiting toxicities. Enrolled patients will receive treatment in 28-day cycles: capecitabine 1500mg/m2 per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14 and oral temozolomide 150 to 200 mg/m2 on days 10 through 14. This will be followed by 14 days off treatment. MRI imaging will be completed after every two cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Phase 2 Study of OBP-301 (Telomelysin™) in Combination With Pembrolizumab and SBRT in Patients With...
Head and Neck Squamous Cell Carcinoma With Inoperable Recurrent or Progressive DiseaseThe purpose of this study is to test the effects, of the research study drug Telomelysin (OBP-301) in combination with pembrolizumab in subjects with inoperable, recurrent, or progressive squamous cell carcinoma of the head and neck. Telomelysin is an investigational treatment, while pembrolizumab and SBRT are approved standard treatments. The combination of these three treatments is also considered investigational.