PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
Peritoneal CarcinomatosisOvarian Cancer Stage IIIB11 moreThe PIPAC nab-pac study is designed to examine the maximal tolerated dose of albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a multicentre, multinational phase I trial.
Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal...
Gastric AdenocarcinomaGastroesophageal Junction Adenocarcinoma1 moreThis phase II trial studies how well heated mitomycin and cisplatin during surgery work in treating patients with stomach or gastroesophageal cancer. Drugs used in chemotherapy, such as mitomycin and cisplatin, 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. Heating a chemotherapy solution and infusing it directly into the abdomen may kill more tumor cells.
A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab...
Ovarian CancerFallopian Tube Cancer1 moreThis is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.
Unimolecular Pentavalent (Globo-H-GM2-sTn-TF-Tn) Immunization of Patients With Epithelial Ovarian,...
Fallopian TubesOvarian Cancer1 moreThe purpose of this study is to 1) test the safety of the vaccine to find out what effects, good and/or bad, it has, and 2) to find out if the vaccine stimulates the immune system. The vaccine in this study will contain several parts. The first part is called an antigen. These antigens or "fingerprints" are found on many cancer cells, especially from the ovaries, fallopian tubes, or peritoneal cavity (inside lining of the abdomen) The purpose of this study is to see if investigators can help the immune system to recognize that cancer cells are not normal and should be removed.
Pharmacokinetic, Safety and Efficacy Study of Nanoparticle Paclitaxel in Patients With Peritoneal...
Peritoneal NeoplasmsThe purpose of this study is to evaluate the safety, pharmacokinetics and preliminary efficacy of an intraperitoneally administered suspension of nanoparticulate paclitaxel in patients with refractory malignancies principally confined to the peritoneal cavity.
Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian,...
Primary Peritoneal CancerAdvanced Epithelial Ovarian CancerThe goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer. Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage.
OPT-821 With or Without Vaccine Therapy in Treating Patients With Ovarian Epithelial Cancer, Fallopian...
Stage IA Fallopian Tube CancerStage IA Ovarian Cancer22 moreThis randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more effective with or without vaccine therapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
Phase 2 AMG 386 in Comb. Paclitaxel for Subjects With Advanced Recurrent Epithelial Ovarian or Primary...
Ovarian CancerFallopian Tube Cancer1 moreThis study is a phase 2, randomized, double-blind, placebo controlled, multi-center study to estimate the improvement in PFS (compared to control subjects) and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel in the treatment of subjects with advanced recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Primary Outcome Measure: • Progression free survival (PFS) Secondary Outcome Measures: Object Response Rate (ORR), duration of response (DOR). CA-125 response rate Safety and Tolerability Change and duration of change on blood levels of CA-125
Continuous Hyperthermic Peritoneal Perfusion (CHPP) With Cisplatin for Children With Peritoneal...
Peritoneal NeoplasmsRetroperitoneal Neoplasms9 moreThere has been no successful treatment of diffuse peritoneal metastasis or carcinomatosis, in childhood tumors. Once this advanced stage of disease is evident, survival is measured in weeks. The selective lethal effect of supranormal temperatures on neoplastic cells and the additive or synergistic effect of combining chemotherapy has been well established in adult clinical trials using continuous hyperthermic peritoneal perfusion (CHPP) for advanced peritoneal adenocarcinoma of gastrointestinal origin, ovarian carcinoma and mesothelioma. This phase I study will evaluate the safety of continuous hyperthermic peritoneal perfusion with escalating doses of intraperitoneal cisplatin in the treatment of children with refractory tumors limited to the abdominal cavity. If tumors are outside the abdominal cavity, the tumors must be able to be controlled. Since CHPP has potential to improve outcome of children with peritoneal and retroperitoneal metastases, this study will evaluate the safety of elevated temperature (40oC) with intraperitoneal cisplatin chemotherapy. Primary Objectives: To determine the MTD and dose-limiting toxicity of intraperitoneal cisplatin given in combination with CHPP as a 90 minute perfusion in children with advanced peritoneal and retroperitoneal solid tumors To determine the safe and tolerable dose of CHPP with cisplatin to be used in Phase II trials To determine the pharmacokinetics of intraperitoneal cisplatin platinum given with CHPP as a 90 minute abdominal perfusion (Optional)
Study of Mirvetuximab Soravtansine in Combination With Bevacizumab, Carboplatin, Pegylated Liposomal...
Epithelial Ovarian CancerPrimary Peritoneal Cancer1 moreThis study comprises a Dose Escalation phase followed by a Dose Expansion phase. Dose Escalation part of the study will assess the safety and tolerability and determine the maximum tolerated dose (MTD) as the recommended Phase 2 (RP2D) dose for each regimen. Participants will be assigned to one of the 4 regimens in Dose Escalation phase: Regimen A: mirvetuximab soravtansine administered with bevacizumab; Regimen B: mirvetuximab soravtansine administered with carboplatin; Regimen C: mirvetuximab soravtansine administered with pegylated liposomal doxorubicin; or Regimen D: mirvetuximab soravtansine administered with pembrolizumab. Dose Expansion of the study will further assess safety, tolerability and preliminary anti-tumor activity of mirvetuximab soravtansine. A Dose Expansion phase is planned for Regimen A and Regimen D and will open pending Sponsor decision; participants enrolled in the Dose Expansion phase will receive study treatment at the MTD or RP2D determined during Dose Escalation. For Regimen A, participants in the Dose Expansion phase may be enrolled according to prior exposure to bevacizumab into 3 Dose Expansion Cohorts as follows: 1) Dose Expansion Cohort 1: bevacizumab naïve; 2) Dose Expansion Cohort 2: bevacizumab pretreated; and 3) Dose Expansion Cohort 3: one to three prior treatments, one of which could have been bevacizumab. A triplet Regimen (Regimen E: mirvetuximab soravtansine + bevacizumab + carboplatin) will be opened to evaluate the safety and tolerability and to assess any early signs of activity in participants dosed with the combination regimen.