Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Bevacizumab

Albumin-Bound Paclitaxel

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Neoadjuvant Carboplatin, Paclitaxel, and Bevacizumab 21 day cycles of carboplatin, paclitaxel, and bevacizumab

Bevacizumab 15 mg/ Kg (from post-op cycle 2) intravenous infusion for 30 minutes in a 21 days' cycle for at least three cycles (best to 6 cycles) followed by 3-weekly maintenance bevacizumab 15 mg/ Kg intravenous infusion for 17 cycles.

Chyong-Huey Lai, MD

This study is to determine the feasibility of postoperative platinum-based chemotherapy plus adjuvant and maintenance bevacizumab after neoadjuvant chemotherapy followed by interval surgery in patients with extensive stage IIIC or IV ovarian, tubal, and peritoneal cancer.

This study is designed to determine the feasibility of administering adjuvant carboplatin, paclitaxel, and bevacizumab without unacceptable significant AE in patients with epithelial ovarian cancer after neoadjuvant carboplatin/cisplatin, and paclitaxel and interval cytoreductive surgery, primary peritoneal cancer or fallopian tube cancer. This study will also investigate progression free and to assess the quality of life.

A Simon minimax two-stage design is employed to determine permit early stopping when a moderately long sequence of initial adverse events occurs. Under this two-stage design, 13 subjects are enrolled at the first stage. If there are \> 3 subjects discontinue treatment due to significant AE in the stage-1, then stop the trial. Otherwise, the second stage is implemented by including the other 14 subjects. The treatment safety will be evaluated and ensured by the occurrence rate of significant AE (or non AE). In stage-1, postoperative adjuvant cycles 2-6 will be observed for defined significant AE.

Patients' or physicians' decision of discontinuation not because of the above-defined significant AEs or due to cancer progression should not be counted as an end-point event.

Postoperative Adjuvant Chemotherapy With Bevacizumab and Maintenance Bevacizumab After Neoadjuvant Chemotherapy for Ovarian Cancer

A Phase II Trial of Postoperative Platinum-based Chemotherapy Plus Adjuvant and Maintenance Bevacizumab After Neoadjuvant Chemotherapy Followed by Interval Surgery in Patients With Extensive Stage IIIC or IV Ovarian, Tubal, and Peritoneal Cancer

Significant AEs include:

1. Hypertension ≥ grade 3
2. Proteinuria ≥ grade 3
3. GI perforation, abscesses and fistulae (any grade)
4. Wound healing complications ≥ grade 3
5. Haemorrhage ≥ grade 3 (any grade CNS bleeding; ≥ grade 2 haemoptysis)
6. Arterial thromboembolic events (any grade)
7. Venous thromboembolic events ≥ grade 3
8. PRES (any grade)
9. CHF ≥ grade 3
10. Non-GI fistula or abscess ≥ grade 2

Following disease progression, the patient will be contacted every 26 weeks (+/- 2 weeks) (until 30 days after the last patient receives the last dose of bevacizumab) in order to capture their survival status

Hoffmann-La Roche

Asian Gynecologic Oncology Group

Taiwanese Gynecolgic Oncology Group

Chang Gung Memorial Hospital

M.D.

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Melanoma

Lung Neoplasms

Whooping Cough

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Vaccines

Monophosphoryl lipid A

Adjuvants, Immunologic

Immunologic Factors

Each patient will receive six doses of the formulation, administered intra-muscular, with an interval of 4 weeks between doses, and the first immunization performed 6 weeks after the completion of standard treatment. NY-ESO-1 (250 mcg) amd MPLA (100 mcg).

NY-ESO-1 combined with MPLA

Immunization os cancer patients with NY-ESO-1 combined with MPLA vaccine

NY-ESO-1 combined with MPLA vaccine

Pedro Giavina-Bianchi, PhD,MD

Marcelo V Aun, MD

Pedro Giavina-Bianchi, MD,PhD

This study is a clinical trial phase I/II. Its goal is to determine the safety, tolerability, immunogenicity and efficacy of a therapeutic vaccine with the tumor antigen NY-ESO-1 combined with the adjuvant MPLA from B. pertussis in cancer patients.

The safety and immunogenicity of the vaccine with the antigen NY-ESO-1 in combination with the MPLA will be evaluated in a phase 1 clinical trial conducted in patients with malignancies that express the antigen (lung, ovarian and melanoma). This study will involve 15 patients, who will receive 250 mcg of NY-ESO-1 and 100 mcg of MPLA.

Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)

Phase I Clinical Trial of a Therapeutic Vaccine for Malignancies, Comprising the Tumor Antigen NY-ESO-1 in Combination With the Adjuvant MPLA of Bordetella Pertussis. Evaluation of Toxicity and Immunogenicity

CTCAE (Common Terminology Criteria for Adverse Events)

IgG against NY-ESO-1 (ELISA). NY-ESO-1-specific T cells CD4+ and CD8+ (ELISPOT and FACs - flow citometry with tetramers).

Butantan Institute

Instituto de Investigação em Imunologia

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Postoperative Adjuvant Chemotherapy With Bevacizumab and Maintenance Bevacizumab After Neoadjuvant Chemotherapy for Ovarian Cancer	NCT02022917	Epithelial Ovar...	Bevacizumab	20 Years - 75 Years	Chang Gung Memorial Hospital
Postoperative Adjuvant Chemotherapy With Bevacizumab and Maintenance Bevacizumab After Neoadjuvant Chemotherapy for Ovarian Cancer	NCT02022917	Epithelial Ovar...	Bevacizumab	20 Years - 75 Years	Chang Gung Memorial Hospital
Clinical Trial of a Therapeutic Vaccine With NY-ESO-1 in Combination With the Adjuvant Monophosphoryl Lipid A (MPLA)	NCT01584115	Cancer. Melanoma. Ovarian Cancer. Lung Cancer.	NY-ESO-1 combin... NY-ESO-1 combin...	18 Years - 60 Years	Instituto de Investigação em Imunologia

Spots Global Cancer Trial Database for ovarian cancer.