Clinical Trials
Clinical trials are an important part of the care available at Piedmont Hospital. Presently, we are enrolling patients in studies for new forms of medical therapy, pain management, and cancer prevention. For additional information on research and clinical trials, contact oncology research at 404-605-1919 or phri@piedmont.org.
The clinical trials currently open are listed below by type of cancer:
- Brain cancer
- Breast cancer
- Gynecological cancer
- Lab studies
- Liver cancer
- Lung cancer
- Multiple Myeloma
- Prostate cancer
- Skin cancer
BRAIN CANCER
Title of Study: RTOG 0525 - Phase III Trial Comparing Conventional Adjuvant Temozolomide with Dose Intensive Temozolomide in Patients with Newly Diagnosed Glioblastoma
Study Summary:
The purpose of this study is to determine whether increasing the duration of the temozolomide treatment after radiation from 5 days out of 28 days (standard-dose schedule) to 21 days out of 28 days (dose-dense schedule) will further improve patient outcomes. This study will find out what effects this change in drug schedule has on the patient and the tumor compared with standard treatment. In addition, this study will try to determine whether the response to temozolomide and the overall outcome depend on whether or not the tumor contains particular genetic material called the MGMT gene.
Treatment:
A sample of the tumor tissue will be submitted to a central lab to determine if the tumor is a glioblastoma and if there is enough tumor tissue to perform the MGMT analysis. If the tissue is not adequate, the subject is not eligible and will not be able to continue on the study.
All subjects determined to be eligible, will begin the study treatment by taking temozolomide at the same time that they receive radiation therapy. Subjects will take temozolomide capsules orally once daily continuously (7 days a week) for a maximum of 7 weeks and receive radiation therapy Monday through Friday for a total of 30 radiation treatments.
After radiation treatments are complete, all subjects will be randomly assigned (by chance) to one of two treatment arms. The two groups include:
Group 1: Temozolomide standard dose schedule (once daily on day 1 through day 5 every 28 days for up to 12 months)
OR
Group 2: Temozolomide dose-dense schedule (once daily on day 1 through day 21 every 28 days for up to 12 months)
The patient will be followed at regular check-ups, including MRI or CT scans, every 3 months after completing treatment for the first year, then every 4 months for the second year, and then every 6 months.
Support provided by: Radiation Therapy Oncology Group
Principal Investigator: Adam Nowlan, M.D.
Contact: For more information, please call 404-605-1919 or email phri@piedmont.org
Title of Study: RTOG 0625 - A Randomized Phase II Trial of Bevacizumab with Irinotecan or Bevacizumab with Temozolomide in Recurrent Glioblastoma
Study Summary:
This study is being done to determine if an investigational cancer treatment called bevacizumab combined with either the chemotherapy agent irinotecan or the chemotherapy agent temozolomide is effective in treating glioblastoma.
Treatment:
A sample of the tumor tissue will be submitted to a central lab to confirm that the tumor is a glioblastoma. All patients with a confirmed glioblastoma will be eligible for the study and will be randomized to one of two groups:
Group 1: Bevacizumab and Temozolomide
OR
Group 2: Bevacizumab and Irinotecan
The assigned treatment will continue for up to 2 years, as long as the tumor does not grow and side effects of the treatment do not prevent the subject from continuing the treatment.
Subjects in both groups will have a magnetic resonance imaging (MRI) done every 8 weeks and blood tests every 2 weeks. Thereafter, follow-up will occur at 1 month after the treatment and on a regular basis indefinitely.
Support provided by: Radiation Therapy Oncology Group
Principal Investigator: Adam Nowlan, M.D.
Contact: For more information, please call 404-605-1919 or email phri@piedmont.org
Title of Study: Phase II Neoadjuvant Trial of Trastuzumab in Combination with Dose-Dense ABI-007 (AbraxaneTM) Followed by Vinorelbine for HER2 Overexpressing Early Stage Breast Cancer
Study Summary:
Previous studies have shown that chemotherapy has the same effect on treating breast cancer whether received before or after surgery. Receiving chemotherapy before surgery, rather than after surgery, may allow the patient to have less extensive surgery. There is no standard chemotherapy before surgery. In previous trials, participants received adriamycin, cytoxan, and docetaxel. The risk of recurrence is 50% lower if patients receive trastuzumab after surgery. Trastuzumab will likely have a similar benefit before surgery.
The purpose of this study is to identify new treatment regimens with better response rates and to find out if the combination of ABI-007 and trastuzumab followed by vinorelbine and trastuzumab can shrink the size of breast tumors and allow preservation of the breast.
Treatment:
All study participants will receive ABI-007, vinorelbine, and trastuzumab. Patients will receive treatment every week for a total of 20 weeks before surgery. After surgery, the patients will receive treatment every three weeks for 32 weeks.
Support Provided by: Abraxis BioScience, Inc. and Georgia Center for Oncology Research and Education
Principal Investigator: Vasileios Assikis, MD
Contact: For more information, please call 404-605-2887 or email phri@piedmont.org
GYNECOLOGICAL CANCER
Title of Study: OCEANS: A Phase II, Multicenter, Randomized, Blinded, Placebo-Controlled Trial of Carboplatin Gemcitabine Plus Bevacizumab in Patients With Platinum-Sensitive Recurrent Ovary, Primary Peritoneal, or FallopianTube Carcinoma.
Study Summary:
This study tests an experimental drug called Bevacizumab. It is called experimental because it is not approved by the U.S. Food and Drug Administration (FDA) to treat ovarian, peritoneal, or fallopian cancer. The purpose of this study is to test if bevacizumab, when given in combination with two other drugs (carboplatin and gemcitabine), is safe, able to delay tumor growth, shrink tumors, or affect how long people with ovarian, peritoneal, or fallopian cancer live.
Treatment:
Patients will be randomly assigned (by chance) to one of two treatment arms. Randomly assigned means a computer will decide who enters each group and each patient has an equal chance (or a 50:50 chance) of being placed in either group. The two groups include:
Treatment with carboplatin and gemcitabine plus bevacizumab.
OR
Treatment with carboplatin and gemcitabine plus placebo (a substance that looks like bevacizumab but is not an active drug [like a sugar pill]).
This is a blinded study meaning neither the patient nor the patient’s doctor will know whether the patient is receiving placebo or bevacizumab.
The treatment will be given by a needle into the vein (also called an intravenous infusion) every 21 days (three weeks) until the tumor grows or if the treatment is stopped for any other reason. After the patient has stopped receiving the study treatment, the study staff will call the patient every three months to ask about their health status.
Support Provided by: Genentech, Inc.
Principal Investigator: Alfred Jenkins, M.D.
Contact: For more information, call 404-605-1919 or email phri@piedmont.org.
Title of Study: OVATURE: Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study Comparing Phenoxodiol (Oral Dosage Form) in Combination with Carboplatin versus Carboplatin with Placebo in Patients with Platinum-Resistant or Platinum-Refractory Late-Stage Epithelial Ovarian, Fallopian or Primary Peritoneal Cancer Following at Least Second Line Platinum Therapy
Study Summary:
The purpose of this project is to see if an anti-cancer drug called phenoxodiol is effective against late stage ovarian cancer, fallopian tube or primary peritoneal cancer. The study will also see if there are any bad effects (also called side-effects) of the drug. Phenoxodiol is an experimental anti-cancer drug, which means it has not been approved for sale by the U.S. Food and Drug Administration (FDA).
Treatment:
This study will randomize patients into one of two groups. Being randomized means the patient is put into a group by chance by a computer. There is an equal chance (a 50:50 chance) of being placed in either group. Neither the patient nor the study doctor can choose the group the patient will be in. The two groups are:
Treatment with phenoxodiol and carboplatin
OR
Treatment with carboplatin and placebo (an inactive pill that looks like phenoxodiol)
The treatment will be given in an outpatient setting. The drug phenoxodiol or placebo (depending upon which group the patient is placed) is given as a capsule. The patient will take the capsules every 8 hours for 4 weeks and repeating this for another 4 weeks. Carboplatin is given intravenously (by a needle placed in a vein) once a week for 4 weeks and repeating this for another 4 weeks. After 8 weeks, the patient will have tests or procedures to see if their cancer is responding to the treatment.
Study Medication Provided by: Marshall Edwards Pty Limited
Principal Investigator: Alfred Jenkins, MD
Contact: For more information, please call 404-605-1919 or email phri@piedmont.org
Title of Study: EXPLORE: Examination of PNH, by Level of CD59 on Red and White Blood Cells, in Bone Marrow Failure Syndromes
Study Summary:
The primary objective of this study is to help determine the percentage of subjects with Aplastic Anemia (AA), Myelodysplastic Syndromes (MDS), and other bone marrow failure syndromes who have the PNH cells in their blood. PNH is an uncommon and potentially fatal blood disease that occurs at almost any age (average age 35 years) and is found equally between men and women. The percentage of patients with AA, MDS, and other bone marrow failure syndromes who have PNH is unclear. However, the determination of this number could represent an opportunity to detect, diagnose, and potentially treat patients with unrecognized PNH disease within these populations.
Treatment:
Subjects will provide a blood sample, which will allow for testing of the red blood cells, white blood cells and platelets. The amount of blood to be collected will be between three and six teaspoons. Patient participation will last for one visit.
Subjects who test positive for the PNH clone will be notified of such by the investigator and will be eligible to enroll in a PNH registry program.
Support provided by: Alexion Pharmaceuticals, Inc.
Principal Investigator: Robert Allen, MD
Contact: For more information, please call 404-605-1919 or email phri@piedmont.org
LIVER CANCER
Title of Study: SGL2005/064: A Phase II Trial of ZIO-101 in Advanced Hepatocellular Carcinoma.
Study Summary:
This study tests an experimental drug called ZIO-101. An experimental drug is one that has not been approved by the U.S. Food and Drug Administration [FDA] for widespread use. This study will test whether ZIO-101 is safe and helps treat liver cancer.
Treatment:
Patients will receive the study drug by an injection, which will take about one hour twice a week with three or four days between each injection. The injections can continue up to six months or until the patient has a bad effect or their cancer gets worse, whichever comes first.
Support Provided by: ZIOPHARM Oncology, Inc
Principal Investigator: Charles Henderson, M.D.
Contact: For more information, call 404-605-2887 or email phri@piedmont.org
LUNG CANCER
Title of Study: MAGRIT: A Double-Blind, Randomized, Placebo-Controlled Phase III Study to Assess the Efficacy of recMAGE-A3 + AS15 Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3-Positive Non-Small Cell Lung Cancer.
Study Summary:
Many patients with lung cancer have surgery to remove the cancer. Although the lung cancer has been removed, there is still a risk that the cancer may return. This study tests an investigational product called MAGE-A3 ASCI to see if it may prevent the cancer from coming back (called recurrence) after surgery has been done. Investigational means that MAGE-A3 ASCI has not been approved by the U.S. Food and Drug Administration (FDA).
It is known that some cancer tissue produces a protein called MAGE-A3. After surgery to remove the cancer, the cancer tissue is tested to see if it does produce the MAGE-A3 protein (meaning it “tests positive”). For those individuals who test positive for MAGE-A3, this study tries to teach their body’s immune system to fight the cancer in the same way that it fights an infection by germs or viruses. Because cancer is produced by an individual’s own body, the immune system does not recognize the cancer cells as it would recognize germs or viruses. It needs to be “trained” to do so. This study attempts this through injections of a protein that is found in the tumor (the MAGE-A3 protein) into the patient’s body, thus training train the body to recognize and destroy the cells with this protein. In this way, it is hoped that any recurrence of cancer will be delayed or prevented.
The purpose of this clinical study is to see whether MAGE-A3 ASCI works, and if it does, to measure its effect.
Treatment:
The study begins either after surgery, or after surgery and chemotherapy if the patient is scheduled to receive chemotherapy by their doctor. After their scheduled treatment, patients are randomly placed (by a computer) into two groups. Randomly placed means that the group into which the patient is placed is decided by chance. The chance that the patient will receive either one of the treatments below is 50/50:
Treatment with ASCI (the investigational product being studies).
OR
Treatment with a placebo (contains no active drug-like a sugar pill).
The treatment consists of 13 shots of ASCI or the placebo into the muscles of the thigh or upper arm. These injections are given at the hospital. After the 13 shots, the patient will visit the hospital every six months for five years. After five years of visits, the patient is contacted by telephone every year for 10 years to find out if the cancer has come back.
This is a double-blinded study, which means neither the patient nor the doctor knows whether the patient is receiving ASCI or placebo injections. However, this information is available to the study doctor if needed in an emergency.
Support Provided by: GlaxoSmithKline Biologicals
Principal Investigator: Vasileios Assikis, M.D.
Contact: For more information, call 404-605-2887 or email phri@piedmont.org.
Title of Study: RTOG 0617 - A Randomized Phase III Comparison of Standard- Dose (60 gy) Versus High-Dose (74 gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patients with Stage IIIa/IIIb Non-Small Cell Lung Cancer
Study Summary:
This study will compare the effects of high-dose radiation therapy with standard dose radiation therapy in patents with lung cancer that has spread to regional lymph nodes and are not a candidate for surgery.
Treatment:
The patient will be "randomized" into one of the study groups described below.
Group 1
Standard or usual dose of radiation therapy plus paclitaxel and carboplatin
vs.
Group 2
High dose radiation therapy plus paclitaxel and carboplatin
A series of follow up tests will be performed in order to determine the effect of the treatment on the patient’s cancer, on their overall health, and on their quality of life.
Support provided by: Radiation Therapy Oncology Group
Principal Investigator: Adam Nowlan, M.D., MPH
Contact: For more information, please call 404-605-1919 or email phri@piedmont.org
Title of Study: UPFRONT - Randomized Phase 3b Study of Three Treatment Regimens in Subjects with Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE® (Bortezomib), Thalidomide, and Dexamethasone (VTD) versus VELCADE® and Dexamethasone (VD) versus VELCADE®, Melphalan, and Prednisone (VMP)
Study Summary:
The purpose of this study is to learn about the safety and effectiveness of the three drug combinations VD, VTD, and VMP, in subjects who have a certain type of cancer. All three drug combinations are considered “experimental” and have not been approved by the FDA for that type of cancer. Each of the individual study drugs making up the three (3) drug combination has been used to treat patients with multiple myeloma. In addition, one (1) of the drugs, thalidomide, has been approved by the FDA to treat newly diagnosed patients when used in combination with dexamethasone. We will determine how the cancer responds to these “experimental” combinations of study drugs by measuring the cancer-related proteins (M protein) in the blood and/or urine. The study will also measure how long it takes for the cancer to show a response to the drug combinations, how long the cancer continues to respond to the drug combinations and how long the cancer maintains a response when the patient is no longer taking any of the study drugs. The study will also evaluate how the patient is feeling throughout the study as well as their use of other medical services.
Treatment:
The treatment period will be conducted in cycles. During this time the patient will come to the clinic 4 times per cycle. The patient’s doctor will review their response to the study treatment throughout the course of the study and make changes to the doses of study drugs if necessary.
This study has 3 phases: Screening, Treatment, and Follow-up. This is an “open-label” study which means that both the patient and the doctor will know what study medications the patient is taking throughout the study. All patients will be randomly assigned to only one of the three drug combinations VD, VTD, or VMP.
During the study, the doctor may discuss with the patient the option of collecting their stem cells to be frozen for potential future stem cell transplantation.
Once the treatment part of the study is completed, the patient will be asked to return to the clinic every 12 weeks to assess their disease status.
Support provided by: Millennium Pharmaceuticals, Inc.
Principal Investigator: Donald J. Filip, MD
Contact: For more information, please call 404-605-1919 or email phri@piedmont.org
PROSTATE CANCER
Title of Study: RTOG 0232 - A Phase III Study Comparing Combined External Beam Radiation and Transperineal Interstitial Permanent Brachytherapy with Brachytherapy Alone for Selected Patients with Intermediate Risk Prostatic Carcinoma.
Study Summary:
The purpose of this study is to compare the effects of two different radiation treatments in patients with prostate cancer. The effects of placing small radioactive pellets (also called seeds) inside a patient’s prostate (brachytherapy) after external radiation therapy will be compared to the effects of using brachytherapy alone in patients with prostate cancer.
This study will also look at the biopsied prostate cancer tissue for information that may help to predict and treat prostate cancer in the future. In addition, the study will gather information about the effects of the treatment on the patient’s quality of life.
Treatment:
Subjects will be randomly assigned (by chance) to one of two treatment arms. The two groups include:
Group 1: External Radiation Therapy and then Brachytherapy
OR
Group 2: Brachytherapy Alone
Subjects placed in Group 1 will receive daily external radiation therapy treatments five days a week (Monday through Friday) for five weeks. Two to four weeks after the completion of external radiation therapy, radioactive seeds will be implanted into the patient’s prostate. The number of needles and seeds varies depending on the size and shape of the patient’s prostate.
Subjects placed in Group 2 will not have radiation prior to the Brachytherapy but will have the radioactive seeds implanted in their prostate after randomization. However, the radioactive seeds will deliver a somewhat higher dose of radiation.
All subjects (Group 1 and Group 2) will have a CT scan of the prostate, a pelvic x-ray, and two chest x-rays 3 to 5 weeks following the radioactive seeds being implanted. Further, four questionnaires about sexual and urinary functioning and overall quality of life will be completed by all subjects prior to treatment, at 4 months, 12 months, and 24 months after treatment and once a year after that for three years.
Support provided by: Radiation Therapy Oncology Group
Principal Investigator: Adam Nowlan, M.D.
Contact: For more information, please call 404-605-1919 or email phri@piedmont.org
Title of Study: RTOG 0521 – A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT VS AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized, High-Risk Prostate Cancer.
Study Summary:
The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for high-risk prostate cancer is more effective than the standard treatment by itself. The kind of treatment that most physicians would consider standard for this stage of prostate cancer combines radiation therapy and hormones. .The use of chemotherapy is experimental in prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments.
Treatment:
Subjects will be randomly assigned (by chance) to one of two treatment arms. The two groups include:
Group 1: Hormonal Treatment then Radiation Therapy
OR
Group 2: Hormonal Treatment then Radiation Therapy then Chemotherapy
Subjects in both Group 1 and 2 will take hormonal therapy for a total of 24 months and will receive radiation therapy for approximately 8 weeks.
Subjects in Group 2 only will receive chemotherapy and prednisone for approximately 18 weeks plus prednisone for another 3 weeks after chemotherapy stops.
When all subjects finish taking the radiation treatments, they will visit their doctor’s office for follow-up exams every 3 months for 2 years, then every 6 months for 3 years, then annually.
Support provided by: Radiation Therapy Oncology Group
Principal Investigator: Adam Nowlan, M.D.
Contact: For more information, please call 404-605-1919 or email phri@piedmont.org
Title of Study: RTOG 0534 - Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed only Radiotherapy (SPPORT) in Prostate Cancer Patients With A Rising PSA after Radical Prostatectomy
Study Summary:
The purpose of this study is to compare the effects, good and/or bad of three treatment methods on participants and their cancer.
Treatment:
The patient will be "randomized" into one of the study groups described below.
Group 1
Prostate bed radiation treatments
vs.
Group 2
Prostate bed radiation treatments + hormone therapy
vs.
Group 3
Prostate bed radiation treatments + nodal radiation therapy + hormone therapy
A series of follow up tests will be performed in order to determine the effect of the treatment on the patient’s cancer, on their overall health, and on their quality of life.
Support provided by: Radiation Therapy Oncology Group
Principal Investigator: Adam Nowlan, M.D., MPH
Contact: For more information, please call 404-605-1919 or email phri@piedmont.org
Title of Study: SYMMETRY - A Randomized, Double-blind, Phase 3 Trial of STA-4783 in Combination with Paclitaxel Alone for Treatment of Chemotherapy-Naive Subjects with Stage IV Metastatic Melanoma
Study Summary:
The purpose of this study is to determine if STA-4783 plus paclitaxel (an approved cancer medicine for cancers other than melanoma) is effective in the treatment of metastatic melanoma compared to paclitaxel alone. Paclitaxel is approved by the FDA for ovarian cancer, breast cancer, Kaposi’s sarcoma, and non-small cell lung cancer.
The study will also evaluate the safety and PK (pharmacokinetics, or how the study drug works in the body; for example, how long it lasts in the body) of STA-4783 plus paclitaxel. Some of the blood samples taken for PK will also be looked at to see if there is any difference in how a certain protein in the blood (called heat shock protein 70) is affected by STA-4783 in combination with paclitaxel.
Treatment:
After completion of the screening tests, it is possible that the patient will not be able to participate in the study. The patient must have acceptable results from all of the screening exams and procedures in order to participate.
Prior to receiving the first dose of study drug(s), photographs will be taken of the patient’s skin lesions if identified by their study doctor.
The patient will receive their first dose of study drug(s) within the 14 days following their screening visit. Study drug(s) are given in cycles that last four weeks. For the first three weeks of each cycle, they will receive a dose once a week. During week 4 of each cycle, they will not receive any study drug(s). This cycle will be repeated until their participation in the treatment portion of the study ends.
The study drug(s), STA-4783 plus paclitaxel or paclitaxel alone, will be administered. Treatment will be given to the patient by IV infusion and it will take about one hour.
The patient will be contacted by the research staff about every 4 weeks (± 1 week) from the date of their last dose of study drug(s) in order to follow their health condition to find out how they are feeling and to learn if they have received any other cancer treatment. The follow-up will continue until the study is completed (about 6 months after the last subject is enrolled in the study) or may stop earlier if the study is closed by the Sponsor.
Support provided by: Synta Pharmaceuticals Corp.
Principal Investigator: Vasileios Assikis, M.D.
Contact: For more information, please call 404-605-1919 or email phri@piedmont.org.
