Gemogenovatucel-T (Vigil) immunotherapy as maintenance in frontline stage III/IV ovarian cancer (VITAL): a randomised, double-blind, placebo-controlled, phase 2b trial.

Background: Gemogenovatucel-T is an autologous tumour cell vaccine manufactured from harvested tumour tissue, which specifically reduces expression of furin and downstream TGF-β1 and TGF-β2. The aim of this study was to determine the safety and efficacy of gemogenovatucel-T in front-line ovarian cancer maintenance.

Methods: This randomised, double-blind, placebo-controlled, phase 2b trial involved 25 hospitals in the USA.

Phase II study of Vigil® DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer.

Objectives: The majority of women with Stage III/IV ovarian cancer who achieve clinical complete response with frontline standard of care will relapse within 2years. Vigil immunotherapy, a GMCSF/bi-shRNA furin DNA engineered autologous tumor cell (EATC) product, demonstrated safety and induction of circulating activated T-cells against autologous tumor in Phase I trial Senzer et al. (2012, 2013) .

Association between serum levels of soluble tumor necrosis factor receptors/CA 125 and disease progression in patients with epithelial ovarian malignancy: a gynecologic oncology group study.

Background: A prospective study was undertaken within the Gynecologic Oncology Group to determine whether serum levels of soluble tumor necrosis factor receptors I (sTNFR-I) and II (sTNFR-II), alone or in combination with CA 125, were associated with clinicopathologic characteristics or outcome in patients with epithelial ovarian malignancies.

Methods: Quantitative immunoassays were performed on valid pretreatment serum specimens obtained from patients with epithelial ovarian malignancies to assess levels of sTNFR-I, sTNFR-II, and CA 125. The authors then analyzed the results of these immunoassays for potential correlations with clinicopathologic characteristics and outcome.

Progress of a Comprehensive Familial Cancer Genetic Counseling Program in the Era of BRCA1 and BRCA2.

BRCA1 and BRCA2 mutation carriers have an increased risk of developing breast and/or ovarian cancer. Technical advances in genetic testing have increased the need for genetic counseling services; therefore, we have developed a counseling program for these individuals. The purpose of this study is to characterize this population, assess level of interest in genetic testing, and evaluate our program over a 5-year period.

A pilot study of whole body hyperthermia and carboplatin in platinum-resistant ovarian cancer.

The aim of this study was to determine whether the addition of whole body hyperthermia (WBH) to carboplatin (CBDCA) can induce responses in patients with platinum-resistant ovarian cancer. 16 pretreated patients with platinum-resistant ovarian cancer were entered on a Systemic Hyperthermia Oncological Working Group (SHOWG) study; (14 patients were eligible with 14 evaluable for toxicity and 12 for response). The patients were treated with WBH (Aquatherm) 41.

Outpatient vaginal cuff brachytherapy for endometrial cancer.

Petereit DG, Tannehill SP, Grosen EA, Hartenbach EM, Schink JC. Outpatient vaginal cuff brachytherapy for endometrial cancer. The objective of this study was to determine the efficacy and complications of postoperative high-dose-rate (HDR) vaginal-cuff brachytherapy (VCB) in patients with endometrial carcinoma.

Human uterine and ovarian expression of growth hormone-releasing hormone messenger RNA in benign and malignant gynecologic conditions.

Objective: To determine uterine and ovarian expression of growth hormone-releasing hormone (GHRH) messenger RNA (mRNA) in benign and pathologic gynecologic states.

Design: Case-control study.

Setting: Tertiary-care academic department.

An individualized intervention to overcome patient-related barriers to pain management in women with gynecologic cancers.

Concerns about reporting pain and using analgesics ultimately can contribute to poor pain management for many individuals. A nursing intervention to address these "patient-related barriers" was developed based on Johnson's self-regulation theory. The purpose of this pilot study was to determine whether provision of individually tailored sensory and coping information about analgesic side effects and specific information to counter misconceptions would enhance pain management in a sample of 43 women with gynecologic cancers.

Paclitaxel hypersensitivity reactions related to bee-sting allergy.

Patients with a history of beesting allergy may have a higher risk of a hypersensitivity reaction with paclitaxel treatment. We suggest careful screening of patients for allergies.

Paclitaxel, carboplatin, and hexamethyl-melamine (taxchex) as first-line therapy for ovarian cancer.

Background: The addition of hexamethylmelamine to therapy with cisplatin, cyclophosphamide, and doxorubicin significantly enhanced outcomes of patients with advanced ovarian cancer. Hexamethylmelamine, also known as altretamine, has potent antineoplastic activity when used as a single agent in patients who have failed to respond to both platinum-based and paclitaxel therapy. We have conducted a pilot study to evaluate the efficacy and safety of adding this drug to the popular ovarian cancer regimen of paclitaxel plus carboplatin.

Whole body hyperthermia induction of soluble tumor necrosis factor receptors: implications for rheumatoid diseases.

Objective: To test the hypothesis that 41.8 degrees C x 60 min whole body hyperthermia (WBH) induces increased serum levels of soluble necrosis factor receptors (sTNF-R).

Methods: We tested the serum of cancer patients for changes in sTNF-RI and RII levels, as a function of time, pre and post: (1) WBH alone, (2) WBH and chemotherapy, i.

An experience with estrogen replacement therapy in breast cancer survivors.

Objective: To evaluate the outcome of breast cancer patients who elected estrogen replacement therapy (ERT).

Study Design: Breast cancer survivors who elected ERT received the preferred regimen of conjugated estrogen 0.625 mg/day with medroxyprogesterone acetate 2.

A pilot study of melphalan, tumor necrosis factor-alpha and 41.8 degrees C whole-body hyperthermia.

Purpose: To evaluate the feasibilitv of sequencing (based on preclinical modeling) tumor necrosis factor-a (TNF) at two dose levels with melphalan (L-PAM) and 41.8 C whole-body hyperthermia (WBH) for 60 min.

Patients And Methods: Nine patients with refractory cancer were treated from October 1995 to June 1997.

Pregnancy-related fibroadenoma of ectopic breast tissue in the vulva.

Background: Pregnancy-related vulvar fibroadenoma of ectopic breast tissue is rare. Management involves diagnosing the mass as a fibroadenoma by physical examination and delaying excision until the postpartum period.

Case: A 31-year-old multigravid woman at 29 weeks' gestation had a right labial mass that was increasing in size.

Rationale and clinical status of 41.8 degrees C systemic hyperthermia tumor necrosis factor, and melphalan for neoplastic disease.

Dramatic clinical results have been obtained in malignant melanoma and sarcoma using hyperthermic limb perfusion in combination with tumor necrosis factor (TNF) and melphalan (L-PAM). In order to extrapolate these results to systemic treatment, a preclinical research program was initiated to study the interactions of hyperthermia, TNF, and L-PAM. Based on these results, a Phase I clinical trial of whole body hyperthermia (WBH) and L-PAM was initiated and completed.

Hormone replacement therapy in breast cancer survivors: a cohort study.

Objective: Our purpose was to measure any adverse effect (if one exists) of hormone replacement therapy administered to breast cancer survivors.

Study Design: Forty-one patients from a group of 77 patients who received hormone replacement therapy after therapy for breast cancer were matched with 82 comparison patients not receiving hormone replacement therapy. Both groups were taken from the same population on the basis of cancer registry of the Cancer Surveillance Program of Orange County and were compared with regard to survival results.

Replacement therapy for breast cancer survivors. A pilot study.

Background: Traditionally, breast cancer survivors were not considered as candidates for hormone replacement therapy (HRT) because of the possibility that an occult metastatic site of disease might be activated, thus negatively influencing the outcome for the patient.

Methods: A retrospective review of 77 breast cancer survivors who have taken HRT was conducted.

Results: Seven recurrences were reported among the 77 patients studied in-depth, with correlations to stage, age, and node and receptor status.

Cytokine induction by 41.8 degrees C whole body hyperthermia.

The potential for 41.8 degrees C whole body hyperthermia (WBH) to enhance ionizing irradiation and cytotoxic chemotherapy without a commensurate increase in normal tissue toxicity is currently receiving renewed clinical interest. Additionally, WBH may have other biological sequela which may be clinically exploited.

Spontaneous release of interleukin-6 by primary cultures of lymphoid and tumor cell populations purified from human ovarian carcinoma.

Interleukin-6 (IL-6) is a cytokine that has been implicated as a growth factor in human ovarian carcinoma, yet the in vivo source of IL-6 in patients remains undefined. We measured IL-6 by ELISA in cell-free ascites (CFA) of 19 patients with ovarian carcinoma. IL-6 was detectable in all samples (mean level 3.

Host-tumor interaction in ovarian cancer. Spontaneous release of tumor necrosis factor and interleukin-1 inhibitors by purified cell populations from human ovarian carcinoma in vitro.

The biological activity of tumor necrosis factor (TNF alpha/beta) and interleukin-1 beta (IL-1 beta) can be blocked by soluble, naturally occurring molecules--TNF alpha/beta binding proteins (BP-55 and BP-75), derived from the extracellular portion of the 55- and 75-kDa TNF alpha/beta membrane receptors, and IL-1 receptor antagonist (IL-1ra), respectively. We examined the levels of these cytokines and their inhibitors in cell-free ascites of 18 patients with advanced ovarian carcinoma by ELISA. Levels of both TNF BP and IL-1ra dramatically exceeded those of TNF and IL-1; thus, it is unlikely that these cytokines are active in ascites from patients with this disease.

A new method of continuous vaginal cuff closure at abdominal hysterectomy.

A new method for vaginal cuff closure at abdominal hysterectomy avoids blood loss and spillage of vaginal contents into the peritoneal cavity. Using two separate running and interlocking absorbable monofilament sutures, the technique keeps the vagina closed at all times and avoids damage to the bladder or ureters. In 77 consecutive patients undergoing abdominal hysterectomy for endometrial cancer, morbidity related to the cuff closure included cuff cellulitis in only 2.

Release of soluble TNF/LT receptors from a human ovarian tumor cell line (PA-1) by stimulation with cytokines in vitro.

We have demonstrated the presence of the 55- and 75-kDa receptor for tumor necrosis factor (TNF) and lymphotoxin (LT) (TNF-R) in serum, and ascites from women with ovarian cancer. The present studies were initiated to begin to examine the possible cellular source of these receptors in women with ovarian cancer. Human ovarian tumor cells (PA-1) were cocultured for 24-48 hr with various levels of recombinant human cytokines (IL-1 beta, IL-4, IFN-gamma) and the supernatants were assayed by ELISA for the soluble forms of each receptor.