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Ongoing Clinical Trials

A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma

This study compares the overall survival of subjects treated with Toca 511 combined with Toca FC to subjects treated according to standard of care after tumor resection for recurrence of glioblastoma or anaplastic astrocytoma. Subjects undergoing resection for first or second recurrence (including this recurrence) of glioblastoma or anaplastic astrocytoma are eligible.

Lead Physician: Jay-Jiguang Zhu, M.D.
Contact: Guangrong (Greg) Lu at (713) 704-7100 or guangrong.lu@uth.tmc.edu

A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II-IVA Vaginal Cancer

Researchers are evaluating the efficacy of an experimental regimen of triapine, cisplatin, and radiation to increase progression-free survival relative to the standard/control regimen of cisplatin and radiation in women with uterine cervix and vaginal cancer. Eligible patients must have a pathologic diagnosis of stage IB2 (> 5 cm), II, IIIB or IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable to curative surgical resection alone.

Lead Physician: Joseph A. Lucci III, M.D.
Contact: Sonia Robazetti, M.D., CCRC at (713) 500-6382 or sonia.c.robazetti@uth.tmc.edu

Phase 3 Study of ADXS11-001 Administered Following Chemoradiation as Adjuvant Treatment for High-Risk Locally Advanced Cervical Cancer

The study is designed to compare the disease-free survival of patients who use the investigational drug, ADXS11-001, to placebo administered in the adjuvant setting following concurrent chemotherapy and radiotherapy. The drug is administered with curative intent to participants with high-risk locally advanced squamous, adenosquamous or adenocarcinoma of the cervix. Eligible patients must be diagnosed with squamous cell, adenocarcinoma or adenosquamous carcinoma of the cervix and must have undergone definitive therapy with curative intent consisting of at least 4 weeks of treatment with cisplatin and a minimum of 40 Gy external-beam radiation therapy.

Lead Physician: Joseph A. Lucci III, M.D.
Contact: Sonia Robazetti, M.D., CCRC at (713) 500-6382 or sonia.c.robazetti@uth.tmc.edu

The OUTBACK Trial: A Phase III Trial of Adjuvant Chemotherapy Following Chemoradiation as a Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone

The OUTBACK Trial is suitable for women with locally advanced cervical cancer (FIGO stage IB1 and node positive, IB2, II, IIIB or IVA). The primary objective of this randomized Phase III trial is to determine if the addition of adjuvant chemotherapy to standard cisplatin-based chemo-radiation improves overall survival. Women are randomized to either A) standard cisplatin-based chemoradiation or B) standard cisplatin-based chemoradiation followed by 4 cycles of carboplatin and paclitaxel chemotherapy. Secondary objectives are to compare progression-free survival, treatment-related toxicity, patterns of disease recurrence, quality of life and psycho-sexual health and the association between radiation protocol compliance and outcomes. Blood and tumor samples are collected from consenting patients for future translational studies. 780 women will be enrolled to determine if the addition of adjuvant chemotherapy can improve the 5-year overall survival rate by ≥ 10%. OUTBACK opened in Australia and New Zealand in 2011. The trial opened in the USA in early 2012.

Lead Physician: Joseph A. Lucci III, M.D.
Contact: Sonia Robazetti, M.D., CCRC at (713) 500-6382 or sonia.c.robazetti@uth.tmc.edu

A Phase II Trial Evaluating Cisplatin and Gemcitabine Concurrent with Intensity-Modulated Radiation Therapy in the Treatment of Locally Advanced Squamous Cell Carcinoma of the Vulva

Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells. This Phase II trial studies how well giving radiation therapy together with gemcitabine hydrochloride and cisplatin work in treating patients with locally advanced squamous cell carcinoma of the vulva. The primary objective is to determine the efficacy of cisplatin, gemcitabine hydrochloride (gemcitabine) and intensity-modulated radiation therapy (IMRT) in achieving a complete pathologic response when used for the primary treatment of locally advanced squamous cell carcinoma of the vulva.

Lead Physician: Joseph A. Lucci III, M.D.
Contact: Sonia Robazetti, M.D., CCRC at (713) 500-6382 or sonia.c.robazetti@uth.tmc.edu