AVAX Technologies Inc (AVXT)

[katter]

When I tried to tell my oncologist online about AVXT, all he could talk about was someone in NYC working on a vaccine, his office keeps writing me it's not relative (to my breast cancer).

Sigh.....I just wanted to get the word out!

Yes, I know, my Mom had ovca, and I do not.

And no, I am concerned for others. Hopefully not myself in this instance.

It is news!

So I looked his guy up and it dates back to 2007.
http://consumer.healthday.com/cancer-information-5/ovarian-cancer-news-104/ovarian-cancer-vaccine-might-extend-survival-606660.html

Dr. Fishman at NYU

Here are some links to other clinical trials, etc.
http://www.uphs.upenn.edu/obgyn/research/ovarian_clinical.htm

Clinical Research Trials

The Department of Obstetrics and Gynecology has a very active clinical research program in every subspecialty. In 2007, we established the Women's Health Clinical Research Center under the direction of Dr. Kurt Barnhart. Many faculty members are trained in epidemiology and biostatistics or public health. There are numerous clinical trials available in reproductive health, contraception, infertility, gynecologic oncology, urogynecology, and obstetrics.

The Division of Reproductive Endocrinology and Infertility has been a member of the Reproductive Medicine Network since it was established in 1990, and is one of eight centers in the country carrying out large, multi-center trials in the area of male and female infertility, and reproductive disorders. The Division of Gynecologic Oncology participates in NCI sponsored clinical trials through the NRG Oncology Group. There are also phase I and phase II clinical trials for cervical, endometrial and ovarian cancers. Population Science trials in cancer prevention are available as well.




General Gynecology

ASTEROID 1 Study - A randomized, parallel-group, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of different doses of BAY 1002670 in subjects with uterine fibroids over 12 months

The University of Pennsylvania is conducting a research study evaluating the safety and effectiveness of an investigational medication for women with uterine fibroids and heavy menstrual bleeding. If you are a woman between the ages of 18 and 50 and have been diagnosed with uterine fibroids, you may qualify to participate. Women in this study will be asked to take the investigational study medication for 3 months. Principal Investigator: Dr. Abike James, MD, MPH

Qualified individuals will receive the investigational study medication, study-related medical exams, and laboratory services at no charge. They will also receive compensation for time and travel. Individuals may qualify if they:

are women, 18 to 50 years of age
have been diagnosed with uterine fibroid(s)
experience heavy menstrual bleeding
are in good general health
are not using hormonal contraceptives or seeking pregnancy
are not using or are willing to stop other treatments for heavy menstrual bleeding

To complete the pre-screening survey for this study, click here.

For more information and to see if you qualify, contact the study coordinator:

Allie Reid, 215.615.4204 / [e-mail]
Reproductive Health / Infertility

ESPARIOS Study - A randomized, double blind, double dummy, parallel group, multi-center phase 2b study to assess the efficacy and safety of different dose combinations of an aromatase inhibitor and a progestin in a vaginal ring versus placebo leuprorelin/ leuprolide acetate in women with symptomatic endometriosis over a 12 week treatment period.

The University of Pennsylvania is conducting a research study evaluating the safety and effectiveness of an investigational medication for women with symptomatic endometriosis. If you are a women 18 years of age or older and have been surgically diagnosed with endometriosis within the past 10 years. Women in the study will be asked to take the investigational study medication for 3 months. Principal Investigator: Dr. Suneeta Senapati, MD, MSCE

Qualified individuals will receive the invitational study medication which is an intravagnial ring, study-related medical exams and laboratory services at no charge. They will also receive compensation for tie and travel. Individuals may qualify if they:

Are a women of the age of 18 years
Have been surgically diagnosed by laparoscopy or laparotomy within 10 years
Moderate to severe endometriosis-associated pelvic pain
Good general heath
Are not actively trying to conceive or do not plan to conceive in the next 6 months
Are not using hormonal contraceptive or willing to stop

Are not using or willing to stop other treatments for endometriosis

For more information and to see if you qualify please complete this online survey,

click here or contact the Research Coordinator: Ashley Singer at 215-615-4201 / [e-mail]

Optimal treatment for women with a Persisting Pregnancy of Unknown Location - a Randomized Clinical Trial of women at risk for an ectopic pregnancy: Active Treatment versus Expectant Management (No Treatment) The “ACT or NOT TRIAL”

Reproductive Medicine Network

This is a multi-site randomized comparative efficacy trial of strategies to manage women identified to have a persisting pregnancy of unknown location (PPUL) (a nonviable gestation). Randomization will be into active versus expectant management. Additionally, women randomized to active management will be equally randomized between two active management strategies Active management A) Determine the location of the pregnancy by a uterine evacuation, followed by a pathologic evaluation. If no evidence of a uterine pregnancy is determined (i.e. non-visualized ectopic pregnancy), begin methotrexate dosage (50 mg/m2 given as an intramuscular injection) B) Empiric methotrexate treatment without determination of the location of the gestation. Target enrollment at Penn is 50 women. Principal Investigator: Dr. Kurt Barnhart

A phase IIb randomized, double blind, comparative study to assess the efficacy, safety, tolerability and inhibition of ovulation of two continuous regimens of oral daily 5 mg or 10 mg of ulipristal acetate (UPA), versus a dose of 5.0mg UPA for 24/4 days.

Contraceptive Clinical Trials Network

This is a research study testing three different dose levels of an investigational birth control pill. The active ingredient in the pill is ulipristal acetate (UPA), an estrogen-free hormonal contraceptive. Participants make visits to our research center twice a week for 6.5 months to have an ultrasound and give a blood sample. The primary objective is to compare the pharmacodynamic effects of 2 continuous dose regimens of ulipristal acetate 5.0 and 10.0 mg-only oral contraception, versus a 24/4 day regimen of UPA 5.0 mg. Secondarily the tolerability and effects of the three different doses will be compared for bleeding, follicle growth, endometrial safety and subject satisfaction. Principal Investigator: Dr. Kurt Barnhart

Serum Bank for Assessment of Markers for Ectopic Pregnancy
The purpose of this protocol is to develop a bank of serum specimens for a series of pilot studies and to determine the predictive ability of serum markers to distinguish among normal first trimester pregnancy, early miscarriage, and ectopic pregnancy. The study population is women experiencing vaginal bleeding and/or cramping in early pregnancy. Serum leftover from routine clinical tests is banked so that these markers can be retrospectively measured and correlated with clinical diagnoses. Principal Investigator: Dr. Kurt Barnhart

Improving Psychological Health and Cardiovascular Disease Risk in Women with PCOS (MANI-PCOS)

The purpose of this clinical randomized trial is to help determine the best treatment plan for women with Polycystic Ovary Syndrome (PCOS) who are overweight or obese and experiencing symptoms of depression. We want to look at how nutrition/dietary counseling and behavioral therapy may improve mood symptoms, response to stress, and risk factors for heart disease measured in blood tests. Study participants will be asked to meet once weekly with a Registered Dietician for 16 weeks and with a Clinical Psychologist for 8 weeks. Women with a diagnosis of PCOS who are overweight/obese and screen positive for symptoms of depression at the Penn PCOS Center may be eligible to participate. Women who decide to participate in the study will receive one of two treatments: 1) Nutrition counseling plus Cognitive Behavioral Therapy, a specific type of therapy that addresses depression and anxiety, 2) Nutrition counseling alone. We want to see if combining treatments has a different effect on mood symptoms, stress, and cardio-metabolic risk factors than nutrition counseling alone. Principal Investigator: Dr. Anuja Dokras

Population Genetics of Polycysytic Ovarian Syndrome
This is a correlational study of androgen levels and gene identification in a sample of Polycystic Ovarian Syndrome (PCOS) patients and is being conducted at two sites: the University of Pennsylvania and the University of Iowa. The target enrollment for this study is 200 sets of women diagnosed with PCOS and both their biological parents, for a total of 600 subjects from both sites. A cohort of 100 women aged 18-50 with PCOS and their two parents will be recruited through the gynecological clinical practices, particularly Penn Fertility care. All subjects collect and submit a sputum sample for genetic analysis. The major goal of this research project, the identification of genes contributing to PCOS, will provide basic understanding of the genotype-phenotype relationships that contribute to features of PCOS. Knowledge of “PCOS genes” will assist physicians in practicing and assessing responses to interventions that promote fertility, improve insulin sensitivity, and treat other aspects of this disorder. Principal Investigator: Dr. Anuja Dokras-Jagasia

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Elagolix in Subjects with Moderate to Severe Endometriosis-Associated Pain

The Violet Petal Study is evaluating the safety and effectiveness of an investigational medication for moderate to severe endometriosis pelvic pain. If you’re a woman age 18 to 49, and have been surgically diagnosed with endometriosis within the last seven years, you’re invited to see if you may qualify for the Violet Petal Study. The purpose of the research study is to evaluate the safety and effectiveness of an investigational medication for the management of moderate to severe endometriosis-associated pain and other endometriosis-related symptoms. Compensation given for time and travel expenses. Principal Investigator: Dr. Suneeta Senapati

Non-Invasive Imaging of Embryo Development

This study is designed to find a correlation between cleavage times in embryo development and live birth successes. This will be done using a miniature camera inside the incubation chambers that creates a time lapsed movie of the growing embryo after implantation. The study hopes to create a clinical standard in the future for choosing the best, most viable, embryos via cleavage times in addition to qualitative observations. Principal Investigator: Dr. Christos Coutifaris

Stability and Epigenetic Structures in ART Children
This five year prospective study seeks to determine whether Assisted Reproductive Technology (ART) increases the possibility of deregulated expression of imprinted genes and/or destabilizes epigenetic chromosomal marking. It is hypothesized that in vitro manipulation procedures and/or intracytoplasmic sperm injection (ICSI) can destabilize the faithful propagation of epigenetic structures in the genomes of cells of the human embryo. With samples of cord blood, cord and placental tissue this study will look at and compare the regulation of such genes in 500 babies conceived with ART and 500 babies conceived without any fertility drugs and/or procedures. Principal Investigator: Dr. Christos Coutifaris

For more information about our clinical trials in reproductive health and infertility, please call 215-662-7727 or send an email to [e-mail]

Oncofertility

Ovarian Tissue Freezing Prior to Chemotherapy or Radiation Therapy
Chemotherapy and radiation therapy for cancer can compromise the ability to become pregnant. The primary objective of this study is to establish a technology that will enable long-term preservation of ovarian function, including the production of viable oocytes, by cryopreservation of ovarian tissue prior to chemotherapy and/or radiation. Another aim of the study is to develop in vitro techniques that will allow maturation of oocytes from the cryopreserved ovarian tissue. Before receiving chemotherapy or radiation therapy, subjects will have one of their ovaries, or small pieces of both ovaries, removed by surgery. The tissues will be frozen by a special method in an effort to prevent the eggs from being damaged. The majority (80%) of the tissue will be stored for potential use in case that the patient is unable to achieve pregnancy in the future, while the remainder (20%) will be used for studying how the eggs can be grown in the laboratory. Female patients, aged 18-42, in need of cancer treatment likely to adversely affect ovarian function, may be eligible to participate. Ovarian tissue cryopreservation for adolescent girls ages 13-17 is available through a similar research protocol at the Children’s Hospital of Philadelphia under principal investigator Dr. Jill Ginsberg. Principal Investigator: Dr. Clarisa Gracia

Follicular and Luteal Dysfunction in Cancer Survivors (Daily Hormone Study)

If you are between the ages of 20-35 or 43-50 with regular menstrual cycles and not using hormonal medications, we need you! Both women with a history of chemotherapy and women who have never had chemo are eligible. Give us a call if you think you might be interested. We would be happy to screen you for eligibility and answer your questions. This is a 1-2 visit study. At your visit, we will do a brief interview, take your height and weight, do a urine pregnancy test and send you home with 2 boxes of 5 ml tubes for daily urine collection and freezing. You will only collect 5mls (about a teaspoon) a day. That’s it! At the end of two menstrual cycles, we will arrange for pickup of the frozen kits or you may deliver them to our office. You will be compensated for the study visit and each completed collection cycle. Principal Investigator: Dr. Clarisa Gracia

Assessing Fertility Potential in Female Cancer Survivors (For Non-Cancer Patients) Healthy women ages 11-35 are invited to participate in a 5-year study comparing changes in ovarian function over time to the same measures in cancer survivors. Eligible women will be asked to complete a yearly questionnaire, brief physical examination, pelvic ultrasound, a blood test andto keep a menstrualdiary. Participants must have regular menstrual cycles (every 21-35 days), a uterus and both ovaries, body mass index (BMI) less than or equal to 30, and no medical condition associated with early ovarian failure. Participants must not have been pregnant or breastfeeding in the 3 months prior to participation, and must not be using or have used hormonal medication including contraceptives in the 3 months prior to study participation. Compensation is available. Principal Investigator: Dr. Clarisa Gracia

Assessing Fertility Potential in Female Cancer Survivors (For Cancer Survivors)
Cancer survivors 15 to 35 years of age with a history of treatment with chemotherapy or radiation are eligible to participate in this study. Eligible women will be asked to come to the Reproductive Research Unit at Penn Fertility Care to complete a questionnaire, a brief physical examination, an ultrasound and a blood test yearly to assess changing ovarian function over time after cancer therapy. Participants will also keep a menstrual diary between annual visits. In addition, participants in this study will have the option of undergoing an additional, more sensitive test to assess their ovarian function. This test is called the clomiphene challenge test and involves taking clomiphene citrate for five days and having a repeat blood draw on the 10th day of the menstrual cycle. Principal Investigator: Dr. Clarisa Gracia

Ovarian Reserve After Cancer: Longitudinal Effects (ORACLE) (For Non-Cancer Patients)
Healthy women ages 11-35 are invited to participate in a 2-year study comparing changes in ovarian function over time to women undergoing treatment for cancer. Participants must have regular menstrual cycles (every 21-35 days), a uterus andat least oneovary, no medical condition associated with infertility, no treatment with chemotherapy or radiation therapy and must not have been treated with chemotherapy or radiation therapy and not have been pregnant or breastfeeding in the 3 months prior to participation. Compensation is available. Principal Investigator: Dr. Clarisa Gracia

Ovarian Reserve After Cancer: Longitudinal Effects (ORACLE) (For Cancer Patients)
Patients about to begin treatment with chemotherapy or radiation therapy, who are between the ages of 11 to 35 years, may participate in a study measuring ovarian function over time. Eligible women will be asked to complete a questionnaire, a brief physical examination, an ultrasound and a blood test before, during and after cancer treatment. Visits will occur every three months for a total of seven visits over 18 months. Every attempt will be made to coordinate research visits with clinical appointments. Principal Investigator: Dr. Clarisa Gracia

Assessment of Fertility and Factors Influencing Reproduction and Menopause in BRCA Mutation Carriers. AFFIRM

Healthy women from ages 18-45 without a significant family history of breast cancer, ovarian cancer, and/or a BRCA mutation, are invited to participate in a study. Your information will be compared to women with increased genetic risk of cancer. The goal of this study is to help women with increased genetic risk of cancer make decisions about when to start their families. This study includes a 30-minute online survey and a hormone measurement (eligible women will collect a few drops of blood on a special card by finger-prick on days 2-4 of their menstrual cycle). Eligible women will receive the blood spot kit by mail, and send the kit back within 24 hours of blood spot collection. Principal Investigator: Dr. Lauren Johnson

For more information about our clinical trials in oncofertility, please call 215-662-7727 or send an email to [e-mail]

Gynecology Oncology
Primary Ovarian Cancer

GOG 225 Can Diet and Physical Activity Modulate Ovarian or Primary Peritoneal Cancer Progression-Free Survival?

Women who have completed first line chemotherapy for ovarian, fallopian tube or primary peritoneal cancer with a complete response can participate in this randomized trial of lifestyle intervention. Both treatment regimens will receive study materials (including a pedometer) and coaching regarding their daily food intake and physical activities.Principal Investigator: Dr. Robert A. Burger
Cervical Cancer

GOG 263 A Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA, Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphdenectomy

Women who have had a radical hysterectomy and are diagnosed with Stage I/IIA cervical cancer with intermediate risk factors will be randomized to receive either external whole beam radiation therapy or external beam radiation therapy with concurrent radio sensitizing chemotherapy. Principal Investigator: Dr. Robert A. Burger

A Phase I Study of Nelfinavir added to Cisplatin chemotherapy concurrent with Pelvic Radiation for locally advanced cervical cancer (II-IVA)

Women with Stage II-IVA cervical cancer will take nelfinavir 1250 mg BID, orally at home, starting 1 week prior to standard weekly cisplatin plus radiation therapy. Principal Investigator: Dr. Fiona Simpkins
Endometrial Cancer

GOG 286B A Randomized Phase II/III Study of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo as Initial Therapy for Measurable Stage III or IVA, Stage IVB, or Recurrent Endometrial Cancer

Women with advanced or recurrent endometrial cancer (if they have not had prior chemotherapy) will receive6 cycle s of carboplatin and paclitaxel with concurrent and maintenance metformin/placebo.Metformin/placebo is taken until progression. Women can have RT prior to starting the trial. They can have surgery following chemo.

Principal Investigator: Dr. Robert A. Burger
Recurrent Ovarian Cancer

UPCC: 19809: A Pilot Clinical Trial of Dendritic Cell Vaccine Loaded with Autologous Tumor for Recurrent Ovarian, Primary Peritoneal or Fallopian Tube cancer.

This is a three cohort sequential clinical trial for subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer to determine the feasibility and safety as well as immunogenicity of OC-DC, an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with intravenous Bevacizumab and cyclophosphamide. Study duration is 24 months. Study Sponsor: Dr. George Coukos. Principal Investigator: Dr. Janos Tanyi

GOG 213 A Phase III Randomized Controlled Clinical Trial Of Carboplatin And Paclitaxel (Or Gemcitabine) Alone Or In Combination With Bevacizumab Followed By Bevacizumab, And Secondary Cytoreductive Surgery In Platinum-Sensitive, Recurrent Ovarian, Peritoneal Primary And Fallopian Tube Cancer

Women with a first time recurrence of ovarian, fallopian tube or primary peritoneal cancer, who have been disease free for at least 12 months AND are considered by their GYN oncologist to be a surgical candidate (meaning that the surgeon feels he/she could remove all visible cancer) will be randomized to either have surgery, or not to have surgery. Women in both regimens will also receive their physician’s choice of chemotherapy, either carboplatin and paclitaxel or carboplatin and gemzar. They will receive 6-8 cycles of chemotherapy. Their physician may also choose whether or not the patient will receive bevacizumab (an anti-angiogenic agent) both with the chemotherapy, and then following chemotherapy indefinitely, every 3 weeks. Principal Investigator: Dr. Robert A. Burger

GOG 281 A Randomized Phase II/III Study to Assess the Efficacy of Trametinib (GSK1120212) in Patients with Recurrent or Progressive Low-grade Serous Ovarian Cancer or Primary Peritoneal Cancer (The LOGS study)

Women with either recurrent or persistent low grade serous ovarian cancer (with unlimited number of prior regimens) will be randomized to get either oral trametinib or the physician’s choice of treatment (letrozole, taxol, tamoxifen, doxil or topotecan).Must have on study biopsy. Can crossover to trametinib if randomized to standard arm, after progression. Principal Investigator: Dr. Robert A. Burger

A Phase 2, Open-Label Study Of Rucaparib In Patients With Platinum-Sensitive, Relapsed, High-Grade Epithelial Ovarian, Fallopian Tube Or Primary Peritoneal Cancer.

The experimental drug being investigated in this study is called rucaparib. Rucaparib is being developed by Clovis Oncology, Inc., a biopharmaceutical company based in the US and the United Kingdom. Rucaparib belongs to class of anti-cancer agents known as PARP inhibitors. PARP is a protein inside cells in the body that helps repair damage to DNA, which is the genetic material that carries the instructions for your body’s growth and development. Cancer can result from changes in a person’s genetic material (sometimes called DNA mutations) and some of these changes can cause cancer cells to grow out of control. Research has shown that PARP inhibitors stop the PARP protein from working, and that can sometimes cause cancer cells to stop growing. If you complete the screening phase and meet all requirements, you will be enrolled into the study. You will take rucaparib twice daily for treatment cycles of 28 days each. During the first treatment cycle, you will have to return to the study center at about half way through the cycle and then again at the end of the cycle. After the first cycle is completed, you will need to return to the study center approximately once every 4 weeks. You can continue with additional treatment cycles for as long as the study doctor thinks it is in your best interest. After you finish study treatment with rucaparib, you will need to complete an end of study treatment visit and then return to the clinic 28 days later for an end of study visit.

Principal Investigator: Dr. Mark A. Morgan


Gynecological Cancer in Women Over 70

Pre-Operative Assessment and Post-Operative Outcomes of Elderly Women with Gynecologic Cancers

Women 70 years old, or older, who are being seen in the office for an presumed ovarian, fallopian tube or primary peritoneal, or high grade serous endometrial cancer will complete a geriatric assessment (self-administered questionnaire). If they go on to get surgery, as determined by their physician, information about their operative course will be collected. Principal Investigator: Dr. Robert A. Burger

For more information about our GOG clinical trials in gynecologic oncology, please call 215-614-0234 or email [e-mail]