A Randomized Phase II Study of Individualized Combined Modality Therapy for Stage III Non-Small Cell Lung Cancer (NSCLC) Save

Date Added
February 4th, 2014
PRO Number
Pro00032186
Researcher
Patricia Griffin
Keywords
Cancer, Cancer/Lung, Drug Studies
Summary

Cancer is a disease caused by alterations in the functions of genes within the cells. In approximately 15% of patients with non-small cell lung cancer, one of two genes is altered significantly (known as EGFR mutation or ALK rearrangement). Erlotinib, a pill, taken on a daily basis produces significant decrease in the size of tumors in patients with advanced stage lung cancer with EGFR mutation. Similarly, another pill, crizotinib, produces significant decrease in the size of tumors in patients with advanced stage lung cancer with ALK rearrangement. However it is not clear how useful these two drugs will be in patients with a less advanced form of lung cancer in the presence of these gene alterations.

The purpose of this study is to find out what effects, good and/or bad, one of the following treatments have on locally advanced, non-operable lung cancer with specific gene alterations (EGFR mutation or ALK rearrangement).

If the tumor has EGFR mutation, subjects will be randomized to either
• Standard treatment: radiation therapy and chemotherapy
or
• Experimental treatment #1: erlotinib for three months, then radiation therapy and chemotherapy

If the tumor has ALK rearrangement, subjects will be randomized to either
• Standard treatment: radiation therapy and chemotherapy
or
• Experimental treatment #2: crizotinib for three months, then radiation therapy and chemotherapy

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

ECOG E1Z11: A Cohort Study to Evaluate Genetic Predictors of Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS) Save

Date Added
January 21st, 2014
PRO Number
Pro00031246
Researcher
Joanna Metzner-sadurski
Keywords
Cancer, Cancer/Breast
Summary

Many women being treated for breast cancer are treated with drugs known as aromatase inhibitors, which stop the production of estrogen in post-menopausal women. Women taking these drugs often report muscle and joint aches. This is referred to as Aromatase Inhibitor Musculoskeletal Symptoms, or "AIMSS." The reasons for these muscle and joint pains are not known. This study is being conducted to determine the good and/or bad effects of an aromatase inhibitor known as anastrazole on post-menopausal women being treated for breast cancer, and whether their genes can help explain how anastrazole affects the body. The study also hopes to look at how the side efffects from hormone therapy influence patients' quality of life and willingness to continue hormonal treatment.

Institution
MUSC
Recruitment Contact
Kelly Hawthorne
864-725-7129
khawthorne@selfregional.org

An Open-Label, Multicenter, Randomized Phase 2 Study Evaluating the safety and efficacy of Docetaxel in combination with Ramucirumab (IMC-1121B) drug product or IMC-18F1 or without investigational therapy as second-line therapy in patients with locally advanced or metastatic transitional cell carcinoma of the bladder, urethra, ureter or renal pelvis following disease progression on first-line platinum based therapy Save

Date Added
January 14th, 2014
PRO Number
Pro00011809
Researcher
Thomas Keane
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Kidney, Men's Health, Women's Health
Summary

This study will compare how bladder cancer responds to treatment with one of three regimens docetaxel, docetaxel with ramucirumab DP or docetaxel with IMC-18F1. The response to treatment will be measured by the length of time on assigned arm before the disease progresses. The study will also look at how long the tumor stays the same size, or in the event of a decrease in tumor size, how long the decrease in tumor size continues. The study will also look at the side effects of the chemotherapy arm compared with the side effects of chemotheapy combined with either investigational agent. The study will also gather information on the levels of ramucirumab DP or IMC-18F1 in the blood.

Institution
MUSC
Recruitment Contact
Jessica Jenkins
843-876-0630
jenkijn@musc.edu

PHASE 2 SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF BRENTUXIMAB VEDOTIN IN COMBINATION WITH BENDAMUSTINE IN PATIENTS WITH RELAPSED OR REFRACTORY HODGKIN LYMPHOMA (HL) Save

Date Added
January 14th, 2014
PRO Number
Pro00031490
Researcher
Robert Stuart
Keywords
Blood Disorders, Cancer, Drug Studies, Men's Health, Women's Health
Summary

This study is for adult patients that have been diagnosed with relapsed or refractory Hodgkin lymphoma (HL). The purpose of this study is to gather information about the effectiveness and safety of a drug called brentuximab vedotin when given in combination with another drug called bendamustine for Hodgkin lymphoma. Patients will receive the study drug on day one of a 21-day cycle for up to 16 cycles. Participants will have follow-up visits approximately every 3 months for the first year. Then the visit will be approximately every 6 months for two years.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@Musc.edu

Phase II Trial of Response-Adapted Therapy Based on Positron Emission Tomography (PET) for Bulky Stage I and Stage II Classical Hodgkin Lymphoma (HL) Save

Date Added
January 7th, 2014
PRO Number
Pro00031502
Researcher
Charles Bowers
Keywords
Cancer, Cancer/Lymphoma, Drug Studies
Summary

This phase II clinical trial is studying how well response-based therapy assessed by PET scan works in treating patients with bulky stage I and stage II Hodgkin lymphoma. PET scans will be obtained during the course of therapy. Researchers will evaluate the usefulness of this PET scan to determine whether radiation may be left out in the treatment of disease if the PET scan shows a response to chemotherapy alone. In addition, a small percentage of patients may have disease that is not adequately treated with ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) and radiotherapy. Researchers hope to identify this group of patients using early PET scans and will change to a chemotherapy treatment called BEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone).

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A PHASE III TRIAL OF ADJUVANT CHEMOTHERAPY AS PRIMARY TREATMENT FOR LOCALLY ADVANCED CERVICAL CANCER COMPARED TO CHEMORADIATION ALONE: THE OUTBACK TRIAL (ANZGOG 0902/GOG-0274/RTOG 1174) Save

Date Added
December 18th, 2013
PRO Number
Pro00016094
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

The objectives of this trial are to find out whether adjuvant chemotherapy (using two other drugs) after chemo-radiation will increase the chances of survival and reduce the risk of tumor recurrence in the pelvis and other places. The risk and severity of side effects and quality of life during and after treatment will also be evaluated and compared. This trial will help the researchers understand the safety and effectiveness of this new treatment regimen for cervical cancer.

Institution
MUSC
Recruitment Contact
Shanta Salzer
843-792-1463
salzers@musc.edu

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High-Risk Prostate Cancer: A Phase III Randomized Trial Save

Date Added
November 7th, 2013
PRO Number
Pro00028856
Researcher
David Marshall
Keywords
Cancer, Cancer/Genitourinary, Prostate
Summary

The purpose of this study is to compare the effects of hormone therapy (androgen deprivation) and radiation therapy to the prostate gland and seminal vesicles with hormone therapy and radiation therapy to the whole pelvic body area to determine which is better.

There are 2 treatment groups in this study:
1) Patients who receive hormone therapy plus radiation therapy to the prostate gland and seminal vesicles
2) Patients who receive hormone therapy plus radiation therapy to the whole pelvis

Institution
MUSC
Recruitment Contact
Kelly Hawthorne
864-725-4111
khawthorne@selfregional.org

A Phase III Randomized Trial of Gemcitabine (NSC# 613327) Plus Docetaxel (NSC# 628503) Followed by Doxorubicin (NCS# 123127) v. Observation for Uterus-Limited, High Grade Uterine Leiomyosarcoma Save

Date Added
October 17th, 2013
PRO Number
Pro00026910
Researcher
Jennifer Young
Keywords
Cancer, Cancer/Gynecological
Summary

This study is for patients who have a specific kind of uterine cancer; called a leiomyosarcoma that was found only in the uterus; and which has been completely removed by surgery. In this study, we are looking to see if giving chemotherapy with gemcitabine plus docetaxel, followed by doxorubicin, to patients whose leiomyosarcoma was found only in the uterus, decreases the chance that the leiomyosarcoma will come back (recur). In this study half the patients will be managed in the standard way, which is to follow them closely with CT scans, and see if the disease ever comes back. The other half of the patients will be treated with chemotherapy and also followed to see if the disease comes back. Patients will be asked to visit the office for follow up exams approximately every four months for the first three years and then every six months for the next two years after enrollment on this study. At the end of this five year period we would like to keep track of the participants' medical condition for the rest of their lives by calling once a year to see how they are doing.

Institution
MUSC
Recruitment Contact
Anne Wulf
843-792-9190
wulf@musc.edu

ANHL1131: INTERGROUP TRIAL FOR CHILDREN OR ADOLESCENTS WITH B-CELL NHL OR B-AL: EVALUATION OF RITUXIMAB EFFICACY AND SAFETY IN HIGH RISK PATIENTS Save

Date Added
October 10th, 2013
PRO Number
Pro00021704
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

A large randomized trial is necessary to evaluate whether rituximab can add benefit to the current chemotherapy regimen. Two pilot studies in children provide preliminary evidence of safety and activity of rituximab in this disease setting that support such a study. A Berlin-Frankfurt-Münster group (BFM) study, which tested a single dose of rituximab administered prior to chemotherapy, has shown tumor responses. A COG pilot study tested the safety and tolerability of the combination of rituximab with LMB chemotherapy and showed no increased short term toxicity.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843.792.2957
kravekjm@musc.edu

A Phase III Clinical Trial Comparing the Combination of Docetaxel Plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node-Positive or High-Risk Node-Negative, HER2-Negative Breast Cancer Save

Date Added
October 3rd, 2013
PRO Number
Pro00017993
Researcher
Frank Brescia
Keywords
Cancer, Cancer/Breast, Drug Studies, Women's Health
Summary

This study is being done for the following reasons:
•This study is being done to find out if a combination of just two chemotherapy drugs, docetaxel and cyclophosphamide, is as good as using different combinations of the chemotherapy drugs doxorubicin and cyclophosphamide, given with either docetaxel or paclitaxel, in treating your type of breast cancer. All of these drugs are used in standard combinations of chemotherapy for breast cancer.
•The researchers also want to learn about the side effects of the combinations of drugs used in this study. Side effect information will also be studied to see if there are any differences between the two-drug and three-drug chemotherapy combinations.
•In order to learn more about cancer tumors, this study includes special research tests that will be done on tumor tissue that was removed during your breast cancer surgery. Information about this study requirement will be explained to you in more detail later in this consent form.

Institution
MUSC
Recruitment Contact
Katherine Halloran
843-792-7035
halloran@musc.edu