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Cancer Trials & Research

Accessible, Personable, Exceptional Care

Cancer patients at Memorial Hermann have access to appropriate clinical trials through their doctors. Any patient participating in a clinical trial at Memorial Hermann receives the standard-of-care treatment, in addition to the new therapy under consideration. When a proven standard-of-care treatment seems to provide insufficient attack against a patient’s cancer, qualified patients can be enrolled in ongoing community-based trials.

Clinical trials are research studies intended to answer scientific questions about human populations, molecular interactions, specific aspects of tumor cells or advancing cancer treatments. There are several different options available:

  • Studies looking at potential causes of cancer and how to prevent them (epidemiological studies)
  • Studies preventing cancer (preventive trials)
  • Clinical studies to treat patients who have previously had cancer (vaccines or combinations to prevent the cancer from coming back)
  • Treatment studies studying new anticancer drugs or combinations

If you or a loved one has been diagnosed with cancer and are interested in pursuing a clinical trial, you should find out more about treatment studies available. Remember today’s treatments were developed through clinical trials. However, it is important to understand the different types of clinical trials available to patients.

Treatment Trials

The development process for cancer drugs is long and expensive. The ultimate goal is to receive drug approval by the Food and Drug Administration to treat different tumor types and clinical situations (early disease, advanced disease, after surgery, etc). During this process, several opportunities to access these investigational drugs are available.

Phase 0

These are studies generally conducted in healthy volunteers or cancer patients with indolent disease looking at the properties of a new anticancer drug or imaging technique before the actual treatment regimen is planned.

Phase I

These trials are the earliest form of research in humans. They usually test new agents or combinations of anticancer drugs looking for toxicities and how well tolerated these agents are. Newer anticancer drugs have increased chances of helping patients and fewer incidences of making them sicker. Careful follow-up of patients usually takes place. Usually fewer than 50 patients take part in these trials.

Phase II

Once the ideal dosing schedule and toxicities are established, investigators look at the drug’s efficacy in patients with a specific type of cancer. These studies usually involve less than 100 patients.

Phase III

Once the drug or combinations of drugs prove to be efficacious, it is compared with the standard treatments in a large trial. Usually several hundreds of patients take part in these trials.

Phase IV

Once approved for use in cancer patients, anticancer drugs continue to be monitored for safety for several years after their initial marketing.

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Available Trials

Current clinical trials and research projects are available for the following cancers:

BONE

For newly diagnosed high-risk Ewing’s Sarcoma patients
Study ID HSC-GEN-02-007: Randomized Phase 2 study of Vincristine, Doxorubicin, Cyclophosphamide and Dexrazoxane (VACdxr) with or without IMMTher for newly diagnosed high-risk Ewing’s Sarcoma
Principal investigator: Eugenie Kleinerman, MD
Learn more.

BRAIN

Molecular and genetic epidemiology of gliomas
Study ID HSC-GEN-06-0336
Principal investigator: Melissa Bondy, MD
Learn more.

Meningioma: Risk factors and quality of life
Study ID HSC-MH-07-0102
Principal investigator: Melissa Bondy, MD
Learn more.

BREAST

Protocol No SW001: A Comparison of Short Acquisition Time Breast Tomosynthesis Fast Mode Mammography to Conventional Mammography in the Visualization and Characterization of Breast Calcifications
Principal investigator: Stephen Rose, M.D.
For more information: Contact Julia Powers, RN, MSN, CCRP, at 713.456.4011.

For patients with stage 0, I, II breast cancer
Study ID HSC-MS-05-0536: Randomized phase 3 study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) for women with stage 0, I, II, breast cancer
Principal investigator: Emily Robinson, MD
Learn more.

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CERVICAL

For patients with recurrent or persistent carcinoma of the cervix
Study ID HSC-MS-03-220: Randomized Phase 3 trial of Paclitaxel plus Cisplatin versus Vinorelbine plus Cisplatin versus Vinorelbine plus Cisplatin versus Gemcitabine plus Cisplatin versus Topotecan plus Cisplatin in stage IVB recurrent or persistent carcinoma of the cervix
Principal investigator: Lois Ramondetta, MD
Learn more.

COLORECTAL

Protocol No A6181104: A Randomized, Phase 2B Study of Sunitinib Plus Oxaliplatin, 5-Fluorouracil and Leucovorin (Folfox) versus Bevacizumab Plus Folfox as First-Line Treatment in Patients with Metastatic Colorectal Cancer
Principal investigator: Dr. Velasquez
Sub Investigator: Dr. Conlon
For more information: Contact Julia Powers, RN, MSN, CCRP, at 713.456.4011.

GYNECOLOGICAL

Gynecological Neoplasms
Study ID HSC-MS-07-0112: Morphologic, immunohistochemical and molecular analysis of gynecological nepolasms
Principal investigator: Xiuzhen Duan, MD
Learn more.

LIVER

For patients with liver tumors
Study ID HSC-MS-04-231: Codified database for the ongoing evaluation of the use of SIRspheres for treatment of liver tumors
Principal investigator: Alan Cohen, MD
Learn more.

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OVARIAN

For epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer patients
Study ID HSC-MH-05-001: Phase 2 study evaluating the utility of Letrozole in the treatment of recurrent, Platinum and Taxan resistant, estrogen receptor (ER) positive, epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer patients
Principal investigator: Lois Ramondetta, MD
Learn more.

PANCREATIC

For patients with locally invasive pancreatic cancer
Study ID HSC-MS-05-0022: Randomized phase 2 clinical trial of optimally scheduled chemo-biotherapy with or without fever-range whole body thermal-therapy (FR-WB-TT) in patients with locally invasive pancreas cancer
Principal investigator: Joan Bull, MD
Learn more.

PEDIATRIC

A retrospective analysis of pediatric melanoma cases in Texas
Study ID HSC-MS-07-0638
Principal investigator: Adelaide Hebert, MD
Learn more.

PROSTATE

Patients who have just been diagnosed with high-risk or locally advanced prostate cancer and have not yet received treatment
Protocol 05-043: Docetaxel (Taxotere) plus six-month androgen suppression and radiation therapy vs. six-month androgen suppression or radiation therapy for patients with high-risk localized or locally advanced prostate cancer: a randomized controlled trial
Sponsor: Dana-Farber Cancer Institute
Principal investigator: William Velasquez, MD
Sub-investigator: Charles Conlon, MD & John Van, MD
For more information: Contact Julia Powers, RN, MSN, CCRP, at 713.456.4011, or Kristin Chandler, RN, CCRP, at 713.456.4073.

Patients who have prostate cancer, have received treatment and now are experiencing rising PSAs
Protocol 20050147: Randomized double-blind, placebo-controlled, multi-center Phase III study of Denosumab on prolonging bone metastasis-free survival in men with hormone refractory prostate cancer
Sponsor: Amgen
Principal investigator: Sam Axelrad, MD
For more information: Contact Julia Powers, RN, MSN, CCRP, at 713.456.4011, or Kristin Chandler, RN, CCRP, at 713.456.4073.

Patients with hormone refractory metastatic prostate cancer previously treated with a Taxotere containing regimen
Protocol EFC6193 TROPIC: A randomized, open-label multi-center study of XRP6258 at 25mg/m² in combination with Prednisone every 3 weeks compared to Mitoxantrone in combination with Prednisone for the treatment of hormone refractory metastatic prostate cancer previously treated with a Taxotere containing regimen
Sponsor: Sanofi-Aventis
Principal investigator: Sam Axelrad, MD
Sub-investigator: Charles Conlon, MD
For more information: Contact Julia Powers, RN, MSN, CCRP, at 713.456.4011, or Kristin Chandler, RN, CCRP, at 713.456.4073

Patients with prostate cancer who have failed first-line Androgen Deprivation Therapy (assessed by rising PSA)
Protocol AVO108943: A randomized double blind parallel group study comparing Casodex 50mg plus placebo to Casodex 50mg plus dutasteride 3.5mg administered for 18 months to men with prostate cancer who have failed first-line Androgen Deprivation Therapy (assessed by rising PSA) followed by a two-year extension phase
Sponsor: GlaxoSmithKline
Principal investigator: Sam Axelrad, MD
For more information: Contact Julia Powers, RN, MSN, CCRP, at 713.456.4011, or Kristin Chandler, RN, CCRP, at 713.456.4073.

Patients with metastatic androgen-independent prostate cancer
Protocol EFC6546 Venice: AVE0005 (VEGF Trap) A multi-center, randomized, double-blind study comparing the efficacy and safety of VEGF trap versus placebo administered every 3 weeks in patients treated with Docetaxel/Prednisone for metastatic androgen-independent prostate cancer
Sponsor: Sanofi-Aventis
Principal investigator: Sam Axelrad, MD
For more information: Contact Julia Powers, RN, MSN, CCRP, at 713.456.4011, or Kristin Chandler, RN, CCRP, at 713.456.4073.

Clinically asymptomatic prostate cancer patients with a rising PSA following definitive local therapy
Protocol XRP6976J/3503: A randomized, open label multi-center, Phase 3, 2-arm study of androgen deprivation with Leuprolide, +/- Docetaxel for clinically asymptomatic prostate cancer subjects with a rising PSA following definitive local therapy
Sponsor: Sanofi-Aventis
Principal investigator: Sam Axelrad, MD
For more information: Contact Julia Powers, RN, MSN, CCRP, at 713.456.4011, or Kristin Chandler, RN, CCRP, at 713.456.4073.

Patients with prostate cancer at high risk of relapse after radical prostatectomy
Study ID HSC-GEN-07-0353: A multicenter, open-label randomized Phase Iii trial comparing immediated adjuvant hormonal therapy (Eligard® - Leuprolide Acetate) in combination with Taxotere® (Docetaxel) administered every three weeks versus hormonal therapy alone versus deferree therapy followed by the same therapeutic options in patients with prostate cancer at high risk of repalse after radical prostatectomy (Xrp6976j/3501 Taxotere® (Docetaxel)
Principal investigator: Kevin Slawin, MD

Prostate cancer screening program
Study ID HSC-GEN-07-0461
Principal investigator: Kevin Slawin, MD

Prostate cancer vaccine
Principal investigator: Kevin Slawin, MD

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UROLOGICAL

Protocol No.SPI-611: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single-Dose Intravesical EOquin as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer
Principal investigator: Samuel Axelrad, MD
For more information: Contact Julia Powers, RN, MSN, CCRP, at 713.456.4011.

Protocol No. SPI-153-08-1: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Ozarelix, in Patients with Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hypertrophy (BPH). 
Principal investigator: Samuel Axelrad, M.D.
For more information: Contact Julia Powers, RN, MSN, CCRP, at 713.456.4011.

Patients with locally advanced/metastatic urothelial tract or bladder cancer
Protocol EFC6668: Randomized study of Larotaxel + Cisplatin (LC) vs. Gemcitabine + Cisplatin (GC) in the first line treatment of locally advanced/metastatic urothelial tract or bladder cancer
Sponsor: Sanofi-Aventis
Principal investigator: Sam Axelrad, MD
Sub-investigator: Charles Conlon, MD
For more information: Contact Julia Powers, RN, MSN, CCRP, at 713.456.4011 or Kristin Chandler, RN, CCRP, at 713.456.4073.

UTERINE

For low-risk Gestational Trophoblastic Neoplasia (abnormal cells inside the uterus)
Study ID HSC-GEN-04-009: Randomized Phase 3 trial of weekly parenteral Methotrexate versus “pulsed” Dactinomycin as primary management for low-risk gestational trophoblastic neoplasia
Principal investigator: Lois Ramondetta, MD
Learn more.

MULTIPLE CANCER TYPES

Dendritic cell vaccine
HSC-MS-07-0484: Pilot study to assess the product manufacturing, characteristics and testing of BP-GMAX-CD1, an adenoviral vector-modified dendritic cell vaccine, using leukapheresis product from healthy blood donors.
Principal investigator: Orieji Illoh, MD
Learn more.

Compassion Use Lenalidomide (Revlimid)
Principal investigator: Joel Abramowitz, MD
Learn more.

Ambulatory Cancer Pain Management: A descriptive study
Study ID HSC-SN-04-038
Principal investigator: Kristin Ownby
Learn more.

For patients with advanced malignancy
Study ID HSC-MS-01-111
Phase 2 study of mild whole body hyperthermia combined with 5-Fluorouacil/Interferon-a/Liposomal Doxorubicin in patients with advanced malignancy
Principal investigator: Joan Bull, MD
Learn more.

For patients with advanced malignancy
Study ID HSC-MS-02-117: Phase 2 clinical trail of timing/schedule optimized combined-modality regimen of Cisplatin + Metronomic low-dose Interon-a (IFN-a) followed by Gemcitabine HCI (Gemzar) in combination with mil, fever-range whole body hyperthermia in patients with advanced malignancy
Principal investigator: Joan Bull, MD
Learn more.

For patients with advanced malignancy
Study ID HSC-MS-04-259: Phase 2 clinical trial of Cisplatin (Platinorl) followed by Gemcitabien HCI (Gemzar) in combination with mild, fever-range, whole body thermal-therapy (FR-WB-TT) of 40° C (104° F) in patients with advanced malignancies
Principal investigator: Joan Bull, MD
Learn more.

Research into the use of thermal therapy, or heat treatment, technically known as hyperthermia for cancer is being conducted at The University of Texas Houston Medical School and its teaching hospital, Memorial Hermann-Texas Medical Center. Thermal therapy treatment has evolved from age-old observations that cancer sufferers who sustained prolonged high fevers due to concomitant infectious disease often witnessed tumor regression or cures.

With modern science and technology, it has become possible to mimic fever by inducing controlled heating of the whole body or individual tissues. The focus of both our laboratory research and clinical research is the use of systemic heating or whole body thermal therapy to induce a fever-like state in order to treat metastatic cancer. Our goal is to rapidly translate the results of laboratory research into clinical protocols. Learn more.

Clinical excellence, leading-edge technology and compassionate patient care help make Memorial Hermann a premier cancer center network in Houston. Memorial Hermann’s accredited Cancer Centers offer a full menu of innovative treatment options and therapies for cancer patients. Whether you are researching prevention, have been newly diagnosed, are currently in treatment or looking for a research trial, Memorial Hermann Cancer Centers provide exceptional, state-of-the-art accessible care. You can find information about breast cancer, prostate cancer, lung cancer, neurological cancer, gynecological cancer and brain cancer.

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