Phase Ib Trial of Folate Binding Protein Vaccine in Ovarian Cancer - Full Text View - ClinicalTrials.gov

Phase Ib Trial of Folate Binding Protein Vaccine in Ovarian Cancer - Full Text View - ClinicalTrials.gov

Phase Ib Trial of Folate Binding Protein Vaccine in Ovarian Cancer

This study is currently recruiting participants.

Verified April 2012 by San Antonio Military Medical Center

First Received on April 16, 2012.   Last Updated on April 17, 2012   History of Changes

Sponsor:	COL George Peoples, MD, FACS
Information provided by (Responsible Party):	COL George Peoples, MD, FACS, San Antonio Military Medical Center
ClinicalTrials.gov Identifier:	NCT01580696

  Purpose

Folate binding protein (FBP) is highly over-expressed in breast, ovarian and endometrial cancers and is the source of immunogenic peptides (E39) that can stimulate cytotoxic T lymphocytes (CTL) to recognize and destroy FBP-expressing cancer cells in the laboratory. The purpose of this study is to test whether a peptide-based vaccine consisting of the E39 peptide mixed with the FDA-approved immunoadjuvant granulocyte macrophage colony-stimulating factor (GM-CSF) is safe and effective at inducing an in vivo peptide-specific immune response. Furthermore, the investigators intend to determine the best dose of the vaccine to utilize to produce this immunity most efficiently. The investigators will determine whether immunity to FBP will prevent clinical recurrence. Additionally, the investigators will compare these results with results from a trial utilizing the E75 peptide (from the HER2/neu protein) in ovarian and endometrial cancer patients in preparation for studying a combination vaccine.

Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer - Full Text View - ClinicalTrials.gov

Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal Cancer - Full Text View - ClinicalTrials.gov

This study is currently recruiting participants.

Verified April 2012 by Mayo Clinic

First Received on December 6, 2006.   Last Updated on April 20, 2012   History of Changes

UK: A Survivorship Care Plan for Gynaecological Cancer Patients - Full Text View - ClinicalTrials.gov

A Survivorship Care Plan for Gynaecological Cancer Patients - Full Text View - ClinicalTrials.gov

A Survivorship Care Plan for Gynaecological Cancer Patients

This study is currently recruiting participants.

Verified April 2012 by Royal Marsden NHS Foundation Trust

First Received on April 20, 2012.

Adenocarcinoma of the Gastroesophageal Junction
Cervical Cancer
Endometrial Cancer
Esophageal Cancer
Fallopian Tube Cancer
Gastric Cancer
Ovarian Cancer
Sarcoma
Vaginal Cancer
Vulvar Cancer

For whom the bell tolls at Prima Biomed - CVac ovarian cancer vaccine

For whom the bell tolls at Prima Biomed

"Prima is developing a treatment for ovarian cancer and, at 22¢, its market capitalisation is $256 million. This is hefty for a company that is not forecast to make a profit for at least another four years (if it ever does)."

"The clinical results Prima Biomed has come up with so far do not seem to support its share price rise from 2¢ or so in early 2009, to peak at 39¢ this time last year. The full results of its preliminary (phase two) are due out in the next few months, but what we know so far is that the data from 21 patients ''has not demonstrated statistically significant results'', in the words of a report by Nomura Equity Research."

Read more: http://www.smh.com.au/business/for-whom-the-bell-tolls-at-prima-biomed-20120422-1xf1f.html#ixzz1sonQHSR0

A prospective multicenter (phase IIIb) trialstudy of Treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis

A prospective multicenter study of treosulfan in elderly patients with recurrent ovarian cancer: results of a planned safety analysis

This open-label multicenter phase-IIIb trial was conducted at 47 German institutions; the first 25 patients analyzed in this safety analysis were recruited in 10 centers.

Background  

Treosulfan, an alkylating agent, has demonstrated activity in recurrent ovarian carcinoma. It is equieffective as oral (p.o.) and intravenous (i.v.) formulation. To explore the preference and compliance of elderly patients regarding p.o. or i.v. treosulfan for the treatment of relapsed ovarian carcinoma, women aged 65 years or older were included in this prospective multicenter study. Since elderly patients usually have several concomitant diseases and experience more treatment toxicity, an interim safety analysis was planned and performed after 25 patients finished therapy to assess the tolerability of the treatment regimens.


Table 1 - 6 

• Patient characteristics
• Concomitant diseases
• Treatment delivery
• Reasons for early therapy discontinuation [less than 12 cycles (i.v.) or 12 months of therapy 
• Non-hematological toxicities: highest grade per patient (in alphabetic order)
• Hematological toxicities: highest grade per patient

"Altogether 16 serious adverse events (SAE) were documented for nine patients. The predominant reason for SAE-reporting was hospitalization (14 reports). Death was the matter for the remaining 2 SAEs. An additional patient was hospitalized due to progressive disease and died in hospital. In all 3 cases, death was concerned as not related to study medication and progress of the underlying malignant tumor was stated as cause of death."

"In summary, the observed toxicities were in the same range as reported in previous studies with significantly younger patients and less comorbidity or with old women having received fewer previous lines of chemotherapy.

There were no unexpected hematological or non-hematological toxicities. Based on this safety analysis, treosulfan proved to be a safe and tolerable therapeutic option in elderly, heavily pretreated patients and the next step of study recruitment was initiated. Of note, the majority of patients in the interim safety population chose i.v. treosulfan over the oral application. Detailed analysis after completion of the trial will hopefully yield new insight into therapy preference and compliance of elderly patients with recurrent ovarian cancer."

Conflict of interest  The trial was supported by Medac GmbH.

Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer - Full Text View - ClinicalTrials.gov

Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer - Full Text View - ClinicalTrials.gov

Phase I Stereotactic Body Radiation for Metastatic or Recurrent Platinum-Resistant Ovarian Cancer

This study is currently recruiting participants.

Verified April 2012 by Stanford University

First Received on December 13, 2011.   Last Updated on April 18, 2012   History of Changes

Sponsor:	Stanford University
Information provided by (Responsible Party):	Stanford University
ClinicalTrials.gov Identifier:	NCT01494012

  Purpose

This phase I trial studies the side effects and the best dose of stereotactic body radiation therapy (SBRT) in treating patients with metastatic or recurrent ovarian cancer or primary peritoneal cancer. SBRT may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

abstract: A phase II evaluation of belinostat and carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma: A gynecologic oncology group study

A phase II evaluation of belinostat and carboplatin in the treatment of recurrent or persistent platinum-resistant ovarian, fallopian tube, or primary peritoneal carcinoma: A gynecologic oncology group study:

Background
Patients with recurrent ovarian cancer have limited options, especially in the context of relapse less than six months from primary platinum-based therapy. This Gynecologic Oncology Group (GOG) study was conducted to evaluate the impact of the histone deacetylase inhibitor, belinostat, in combination with carboplatin in women with platinum-resistant ovarian cancer.

Methods 
Eligible patients had measurable, recurrent disease within six months of their last dose of a platinum-based combination. Belinostat was dosed at 1000mg/m² daily for five days with carboplatin AUC 5 on day three of 21-day cycles. The primary endpoint was overall response rate (ORR), using a two-stage design.

Results
Twenty-nine women enrolled on study and 27 were evaluable. The median number of cycles given was two (range 1–10). One patient had a complete response and one had a partial response, for an ORR of 7.4% (95% CI, .9%–24.3%). Twelve patients had stable disease while eight had increasing disease. Response could not be assessed in five (18.5%). Grade 3 and 4 events occurring in more than 10% of treated patients were uncommon and limited to neutropenia (22.2%), thrombocytopenia (14.8%), and vomiting (11.1%). The median progression-free survival (PFS) was 3.3months and overall survival was 13.7months. PFS of at least six months was noted in 29.6% of patients. Due to the lack of drug activity, the study was closed after the first-stage.

Conclusions 
The addition of belinostat to carboplatin had little activity in a population with platinum-resistant ovarian cancer.

abstract: Phase I trial of intraperitoneal pemetrexed, cisplatin, and paclitaxel in optimally debulked ovarian cancer.

Phase I trial of intraperitoneal pemetrexed, cisplatin, and paclitaxel in optimally debulked ovarian cancer.

Abstract

PURPOSE:

This phase I trial evaluated intraperitoneal (IP) pemetrexed, cisplatin, and paclitaxel in optimally debulked ovarian cancer.

Phase 1 - TKM 080301 for Primary or Secondary Liver Cancer - Full Text View - ClinicalTrials.gov (ovariancolorectal/pancreas/gastric (stomach)/breast)

TKM 080301 for Primary or Secondary Liver Cancer - Full Text View - ClinicalTrials.gov

Colorectal Cancer With Hepatic Metastases
Pancreas Cancer With Hepatic Metastase
Gastric Cancer With Hepatic Metastase
Breast Cancer With Hepatic Metastase
Ovarian Cancer With Hepatic Metastase

TKM 080301 for Primary or Secondary Liver Cancer

This study is currently recruiting participants.

Verified February 2012 by National Institutes of Health Clinical Center (CC)

First Received on September 16, 2011.   Last Updated on March 9, 2012   History of Changes

Sponsor:	National Cancer Institute (NCI)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT01437007

  Purpose

Background:

Cancer in the liver can start in the liver (e.g., primary liver cancer or hepatocellular cancer) or spread to the liver from cancers in other parts of the body (e.g. colon, pancreas, gastric, breast, ovarian, esophageal cancers, cancer with metastases to the liver.) People who have tumors that can be removed by surgery live longer than those whose cancer cannot be removed. Chemotherapy can shrink some tumors in the liver, which also helps people to live longer, and sometimes chemotherapy can shrink tumors enough that they can be removed by surgery. However, most chemotherapy drugs do not work well on tumors in the liver. In this study we are testing a new drug, TKM-080301, given directly into the cancer blood supply in the liver circulation, to see if it will cause tumors to shrink.

Objectives:

- To test the safety and effectiveness of TKM-080301 for cancer in the liver that has not responded to standard treatments.

still recruiting: A (phase 11) Study of MK-1775 in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone for Participants With Platinum-Sensitive Ovarian Tumors With the P53 Gene Mutation (MK-1775-004) - Full Text View - ClinicalTrials.gov

Official Title:
A Randomized, Phase II Study Evaluating MK-1775 in Combination With Paclitaxel and Carboplatin Versus Paclitaxel and Carboplatin Alone in Adult Patients With Platinum Sensitive p53 Mutant Ovarian Cancer

 Criteria

Inclusion Criteria:

• Histologically confirmed non-low grade, non-borderline (low malignant potential) ovarian cancer which has progressed after paclitaxel / carboplatin therapy.
• Platinum-sensitive disease. The earliest evidence of progression must have occurred at least 6 months following the completion of the most recent platinum-based treatment.
• Measurable disease.
• Available tumor sample(s).
• Performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
• Adequate organ function.

not yet recruiting: phase 11/BRCA - Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer - Full Text View - ClinicalTrials.gov

Condition:
brca1 Mutation Carrier
brca2 Mutation Carrier
Fallopian Tube Cancer
Ovarian Cancer
Primary Peritoneal Cavity Cancer

Criteria

DISEASE CHARACTERISTICS:

• Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma AND carry a germline mutation in BRCA1 or BRCA2 (confirmation required via Myriad test report); histologic documentation of the original primary tumor is required via the pathology report........

Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

This study is not yet open for participant recruitment.

Verified February 2012 by National Cancer Institute (NCI)

First Received on February 22, 2012. No Changes Posted

Sponsor:	Gynecologic Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT01540565

recruiting: Validation of a Mouse Model of Pancreatic Carcinogenesis - Full Text View - ClinicalTrials.gov (note: brca1/brca2/Ashkenazi Jew)) pancreatic cancer tissue)

First Received on April 12, 2010. Last Updated on February 14, 2012 History of Changes

Purpose

The primary aim of this study is to determine if mutations of BRCA1 and BRCA2 result in different precancerous pathways to pancreatic ductal adenocarcinoma (PDAC), as suggested in our validated mouse model.

Genomic DNA will be isolated on normal tissue obtained from patients who underwent pancreatic resection for PDAC, intraductal papillary mucinous neoplasm (IPMN) or mucinous cystic neoplasm (MCN).

Tissue will be examined for the three most common founder mutations in Ashkenazi Jews. In the cases in which BRCA1 or BRCA2 mutations are found, heterozygote normal and abnormal tissue will be examined to look for mutations in the other BRCA1 or BRCA2 allele. The interaction between other cancer causing genes with BRCA1/2 will also be evaluated by comparing the sequences of the other genes in pre-cancerous lesions.

We hypothesize that BRCA1- and BRCA2-mediated pancreatic ductal adenocarcinoma progresses through the PanIN route, as seen in both BRCA1 and BRCA2 murine (mouse/mice)models of pancreatic cancer. We further hypothesize that BRCA1 mutations may enable an additional pre- neoplastic pathway through MCN, and that IPMN may embody yet another pre- neoplastic pathway.

Study Population

All subjects have a tissue-confirmed diagnosis of pancreatic adenocarcinoma, MCN or IPMN and underwent surgical resection for pancreatic adenocarcinoma, MCN or IPMN at Columbia-Presbyterian Medical Center.

Criteria

Inclusion Criteria:

• Tissue-confirmed diagnosis of pancreatic adenocarcinoma, MCN, or IPMN.
• Underwent surgical resection for pancreatic adenocarcinoma, MCN, or IPMN.

Phase 1/11 Fenretinide/LXS Oral Powder Plus Ketoconazole in Recurrent Ovarian Cancer - Full Text View - ClinicalTrials.gov

 Wiki:  
Fenretinide (4-hydroxy(phenyl)retinamide; 4-HPR) (INN) is a synthetic retinoid deriverative. Retinoids are substances related to vitamin A.

 Wiki:
Ketoconazole ( /ˌkiːtɵˈkoʊnəzɒl/) is a synthetic antifungal drug used to prevent and treat fungal skin infections, especially in immunocompromised patients such as those with AIDS or those on chemotherapy. 

~~~~~~~~~~~~~~~~~~~~
  
Criteria

Inclusion Criteria:

• Recurrent epithelial ovarian cancer or primary peritoneal carcinoma that can be platinum sensitive or platinum resistant
• SWOG Performance Status 0-2
• Previously received a platinum and paclitaxel containing regimen
• Projected Life Expectancy of at least 3 months
• Adequate bone marrow function
• Adequate organ function
• Must have received at least 1 prior salvage regimen for recurrent ovarian cancer
• Recovery from acute toxicities from surgery, radiation or chemotherapy
• At least 3 weeks from last therapy

Exclusion Criteria:

• Prior fenretinide oral capsule use allowed. If prior IV fenretinide use, must contact study chair for eligibility
• Second malignancy within last 5 years
• Use of concomitant antioxidants, such as vitamin C or E
• Untreated or symptomatic brain metastases
• History of hypertriglyceride levels > 200 mg/dl; triglyceride levels < 200 and receiving treatment are okay.
• Use of certain medications is prohibited - contact study coordinator for information

not yet recruiting: Trial of (neoadjuvant) Chemotherapy in Ovarian, Fallopian Tube and Peritoneal Carcinoma - Full Text View - ClinicalTrials.gov

Trial of Chemotherapy in Ovarian, Fallopian Tube and Peritoneal Carcinoma

This study is not yet open for participant recruitment.

Verified January 2012 by University of Kentucky

First Received on January 18, 2012. Last Updated on January 26, 2012 History of Changes

Purpose

This is a prospective study to evaluate the hypothesis that platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy is associated with improved maximal surgical cytoreduction rates, comparable survival, decreased morbidity, and increased quality of life in patients with International Federation of Gynecologic Oncology stages IIIC and IV ovarian, primary peritoneal, or fallopian tube cancer when compared to historical controls and to evaluate the hypothesis that cancer induced inflammation is a predictor of poor prognosis and response to therapy in this group of ovarian cancer patients.

phase 11 - (Mayo) Ovarian Cancer Clinical Trial: Intra-op Detection of Occult Ovarian Carcinoma Using a Folate-Alpha Receptor Specific Fluorescent Ligand

Blogger's Note: as per criteria, recurrent ovarian cancer patients do not qualify for this study

Verified by: Mayo Clinic, January 2012

First Received: January 12, 2012 | Last Updated: January 17, 2012 | Phase: Phase 2 | Start Date: January 2012

Overall Status: Not yet recruiting | Estimated Enrollment: 50

not yet recruiting: Integrated Molecular Profiling in Advanced Cancers Trial - breast, non-small cell lung, colorectal, ovarian, phase 1 (patients) - Full Text View - ClinicalTrials.gov UHN (Toronto)

 Advanced cancer

Advanced breast, non-small cell lung, colorectal and ovarian cancers; as well as patients who are phase I trial candidates

 

Purpose

Substantial progress has been made in the treatment of cancer through the use of targeted therapies, but what works for one patient might not work for another patient. Certain drugs are now being developed that target specific molecules in the body that are believed to be part of the disease.

Biomarkers are specific characteristics of the cancer that may help provide prognostic information (i.e. how well patients will be regardless of the treatments given) or help predict sensitivity or resistance to a specific treatment.

The study will collect archival tumor samples (previously collected biopsy or surgical tumor samples) to provide biomarker data about a patient's cancer, in order to help their physicians to identify which clinical trials of molecularly targeted therapies may be most appropriate for the patient in the future.

Integrated Molecular Profiling in Advanced Cancers Trial (IMPACT)

This study is not yet open for participant recruitment.

Verified on January 2012 by University Health Network, Toronto

First Received on January 4, 2012.   Last Updated on January 5, 2012   History of Changes

Sponsor:	University Health Network, Toronto
Collaborator:	Princess Margaret Hospital, Canada
Information provided by (Responsible Party):	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT01505400

Pilot Program to Personalize Care & Improve Quality of Life for Women With Recurrent Ovarian Cancer - Full Text View - ClinicalTrials.gov (CAM)

 This study is currently recruiting participants.

Verified on August 2011

First Received on August 16, 2011.   Last Updated on August 17, 2011
Purpose

The purpose of this study is to find out if complementary and alternative medicines (CAM) should be included with traditional therapy for women with recurrent ovarian cancer. Some of the alternative medicines include non-traditional drug and herbal therapies along with dietary and nutritional strategies. Only a few of these alternative medicines have been tested with women with ovarian cancer.

A weekly topotecan and biweekly bevacizumab combination demonstrates acceptable toxicity and encouraging efficacy in patients with platinum-resistant

Note: pay particular attention to the side effects/adverse events

abstract: Sorafenib as a third line therapy in patients with epithelial ovarian cancer or primary peritoneal cancer: A phase II study

CONCLUSION: Sorafenib fails to achieve sufficient objective response or sustained disease stabilization as third-line treatment for EOC.

ongoing: Research Study in Patients With Advanced Epithelial Ovarian Cancer - Full Text View - ClinicalTrials.gov

Purpose

RATIONALE: Analyzing tissue samples from patients in the laboratory may help doctors learn more about cancer.

PURPOSE: The purpose of this study is to analyze tissue samples from patients with ovarian cancer in the laboratory.

Condition	Intervention
Ovarian Cancer	Genetic: comparative genomic hybridization Genetic: cytogenetic analysis Genetic: gene rearrangement analysis Genetic: microarray analysis Genetic: mutation analysis Genetic: polymerase chain reaction