ACNS0821: Temozolomide with Irinotecan versus Temozolomide, Irinotecan plus Bevacizumab (NSC# 704865, BB-IND# 7921) for Recurrent/Refractory Medulloblastoma/CNS PNET of Childhood, A COG Randomized Phase II Screening Trial Save

Date Added
July 11th, 2013
PRO Number
Pro00024598
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

There is no current standard treatment for recurrent/refractory
medulloblastoma/PNET. The combination of the drugs temozolomide and
irinotecan has been used to treat adults and children with other types of cancer.
The combination has also been used in previous studies to treat a small number
of children with recurrent or refractory medulloblastoma/PNET as well as other
recurrent tumors, with encouraging results. This study uses the results of these
earlier studies, and looks at how well giving temozolomide and irinotecan daily
for 5 days every 28 days works when given to children and young adults with
recurrent or refractory medulloblastoma/PNET.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years Save

Date Added
June 13th, 2013
PRO Number
Pro00024678
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Pediatrics
Summary

Ependymoma is a type of rare childhood cancer that occurs in the brain and spinal cord. Survival statistics are generally disappointing with a 5-year survival of 50-64%. The standard of care for ependymoma is maximal surgical resection followed by radiation therapy directed at the primary site of disease.

Radiation therapy is associated with immediate and long-term toxicities in children, especially young children. For this reason, it has been the practice of some doctors not to give radiation therapy to children with ependymoma when the tumor has been completely surgically removed. The investigators who designed this study have created strict measures to choose those who will not receive additional treatment after surgery and careful follow-up to minimize the risks to those who are assigned to observation only.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of EVEROLIMUS in Patients with High-Risk, Hormone Receptor-Positive AND HER2/neu Negative Breast Cancer Save

Date Added
May 20th, 2013
PRO Number
Pro00022260
Researcher
Lindsay Peterson
Keywords
Cancer, Cancer/Breast
Summary

This study is for women or men with hormone responsive breast cancer that has already been removed by surgery and have completed any required chemotherapy or radiation. The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney cancer. It is considered investigational for breast cancer patients. In this study subjects will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.
It is expected that subjects will be enrolled in this study for approximately 54 weeks or until side effects become too great, or until cancer returns. After subjects are finished with study treatment, they will return to the clinic every six months for the first 2 years and then yearly for the next 10 years.

Institution
MUSC
Recruitment Contact
Marietta Gustilo
843-792-2584
gustilom@musc.edu

A PHASE III TRIAL OF 6 VERSUS 12 TREATMENTS OF ADJUVANT FOLFOX PLUS CELECOXIB OR PLACEBO FOR PATIENTS WITH RESECTED STAGE III COLON CANCER Save

Date Added
April 30th, 2013
PRO Number
Pro00024065
Researcher
Paul O'brien
Keywords
Cancer, Cancer/Gastrointestinal, Men's Health, Women's Health
Summary

This study is for subjects who have cancer of the colon, which has been surgically removed, but has spread to lymph nodes. This study is being done to evaluate the effects (good and bad) of different chemotherapy treatments. One of the common combinations of chemotherapy drugs used to treat this type of cancer includes 5-fluorouracil (also called 5-FU), leucovorin and oxaliplatin, and is also called ?FOLFOX?. The Food and Drug Administration (FDA) has approved each of these drugs as treatment for colon cancer. FOLFOX is a standard treatment used to prevent colon cancer from coming back (recurrence).
In this study, researchers will evaluate the effects (good and bad) of an oral drug called celecoxib when given in combination with FOLFOX chemotherapy. Celecoxib is approved by the FDA to treat arthritis and some other painful conditions. The addition of celecoxib to FOLFOX chemotherapy is considered investigational. One of the purposes of this study is to determine if giving subjects celecoxib (by mouth) and chemotherapy decreases the risk of colon cancer recurrence.
This study will also look at whether receiving FOLFOX chemotherapy for 6 treatments (12 weeks) is as good as 12 treatments (24 weeks) in preventing recurrence of colon cancer. Currently, the standard of care is 12 treatments with FOLFOX. In this trial, researchers will explore whether 6 treatments are as effective as 12 treatments and whether side effects can be reduced with fewer treatments. It expected that subjects will be enrolled in this trial for up to 3 years.

Institution
MUSC
Recruitment Contact
Andie Adelman
843-792-1507
adelman@musc.edu

A Randomized Phase III Trial of the Value of Early Local Therapy for the Intact Primary Tumor in Patients with Metastatic Breast Cancer Save

Date Added
April 18th, 2013
PRO Number
Pro00015069
Researcher
Megan Ruppel
Keywords
Cancer, Cancer/Breast
Summary

The purpose of this study is to compare the good and bad effects of a new approach that includes surgery plus radiation for the tumor in your breast to the standard approach of continued treatment with the medication which is working to control your tumor.

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

A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or CT 2103 (IND# 70177) Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancer who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy Save

Date Added
April 4th, 2013
PRO Number
Pro00020221
Researcher
William Creasman
Keywords
Cancer, Women's Health
Summary

This study is for patients with ovarian, primary peritoneal or fallopian tube cancer that has been confirmed by surgery. Primary peritoneal and fallopian tube cancers are considered identical to ovarian cancers in terms of microscopic appearance and treatment; they differ only by the initial body site of cancer development. In this research study, women with advanced ovarian, primary peritoneal or fallopian tube cancer who have no evidence of disease after the completion of initial chemotherapy will be randomly assigned (like the flipping of a coin) to one of the three possible treatment regimens to determine which will result in longer patient survival rates if continued once a month for 12 months versus stopping all chemotherapy until there is evidence of recurrence of the disease process. Patients have an equal chance of being placed in any one of the three regimens. Neither the patient nor the study doctor will decide which regimen will be received. Two different chemotherapy regimens and one regimen including no further treatment will be examined and compared. The first of the chemotherapy arms, paclitaxel, is a standard chemotherapy drug used to treat ovarian cancer. The second agent, CT-2103, is an experimental drug with anti-cancer activity similar to that of paclitaxel.

Patients will undergo a thorough check-up prior to the start of treatment. Additionally, they will be asked to complete a questionnaire about their quality of life a total of six times: once before going on the study, 2, 4, 6 and 12 months later, and then one year after completing treatment.

If patients are randomized to receive either paclitaxel or CT-2103, they will be given the drug, once a month through their vein, for a maximum of 12 monthly cycles. The paclitaxel is delivered over 3 hours, while CT-2103 is given as a 10-20 minute infusion.

This study is also interested in testing samples of patients? blood and tumors to determine if this testing can be used in the future to determine which patients may respond to treatment, have side effects or have a good prognosis.

Patients randomized to receive either paclitaxel or CT-2103 will recieve treatment for a maximum of 12 months depending on how well they respond and the seriousness of any side effects. The study doctor will follow patients' medical condition by office visits every three months for two years and then every six months for three more years.

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

AALL1131: A Phase III Randomized Trial for Newly Diagnosed High Risk B-precursor Acute Lymphoblastic Leukemia (ALL) Testing Clofarabine (IND# 73789, NSC# 606869) in the Very High Risk Stratum Save

Date Added
March 14th, 2013
PRO Number
Pro00016822
Researcher
Jacqueline Kraveka
Keywords
Adolescents, Cancer, Cancer/Leukemia, Pediatrics
Summary

To collect information about the patient's leukemia and to seek the optimal treatment for children with ALL based on the individual level of risk of the cancer coming back after treatment. The risk groups are defined as a result of recent research conducted by the Children?s Oncology Group (COG). We would like to learn if the use of an experimental intrathecal therapy (ITT), which has been given to many people with ALL and has been well tolerated, would be better at preventing relapse in the central nervous system and improve disease outcomes in children with High Risk ALL.

Institution
MUSC
Recruitment Contact
Jacqueline Kraveka
843-792-2957
kravekjm@musc.edu

Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas Save

Date Added
March 12th, 2011
IRB Number
19663
Researcher
Scott Lindhorst
Keywords
Brain, Brain Tumor, Cancer, Cancer/Brain, Drug Studies
Summary

This study is for patients with a low grade glioma (a slow growing tumor in the brain). The purpose of this study is to compare the effects, good and/or bad, of adding the chemotherapy pill temozolomide to radiation. Temozolomide is an experimental drug for low-grade gliomas. Patients will be randomly assigned to 1 of 2 groups. One group will receive radiation alone, while the other group receives Temozolomide chemotherapy in addition to the radiation. Patients will receive radiation for 5.5 weeks; patients may also take temozolomide during the 5.5 weeks of radiation and for up to one year thereafter. Follow-up exams will occur every 3 months for 15 years.

Institution
MUSC
Recruitment Contact
Bo Keller
843-792-1286
Kellej@musc.edu

A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Cemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma Save

Date Added
March 7th, 2011
IRB Number
20167
Researcher
Michael Lilly
Keywords
Bladder, Cancer, Cancer/Genitourinary, Drug Studies, Urinary
Summary

The purpose of this study is to compare the effects, good and/or bad, of the combination of the chemotherapy drugs gemcitabine and cisplatin (chemotherapy) with the combination of gemcitabine, cisplatin, and the experimental drug bevacizumab on you and your transitional cell cancer to find out which is better. Bevacizumab is an antibody that we think can block a protein called VEGF and inhibit the growth of new blood vessels. Bevacizumab has been approved by the FDA for the treatment of metastatic colorectal, lung, and breast cancer, but for transitional cell carcinoma, it is not FDA-approved and should be considered experimental.

Bevacizumab is the common name for the commercial drug Avastin. The bevacizumab used in this trial, however, is for use in research studies only and may be made at locations different from those where Avastin is made. Although some differences may exist, bevacizumab for research use and the commercial drug, Avastin, are manufactured by a similar process, meet similar standards for final product testing and are expected to be very similar in safety and effectiveness. The combination of gemcitabine and cisplatin is one commonly used treatment that has been shown to make some patients with transitional cell carcinoma live longer. This research is being done to see if adding bevacizumab to gemcitabine and cisplatin will delay the growth of your cancer and allow you to live longer.

This is a randomized trial so patients will receive one of two treatments: Arm A: Gemcitabine, cisplatin, and placebo (sugar water or salt water)OR Arm B: Gemcitabine, cisplatin, and bevacizumab (an experimental drug). Arm A is the current standard treatment for patients with this type of cancer. Your participation in this trial will continue for as long the cancer is responding to or is stabilized by the drugs and you do not have any severe side effects from the drugs.

Institution
MUSC
Recruitment Contact
Alan Brisendine
843-792-9007
matsont@musc.edu

A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy Save

Date Added
October 5th, 2009
IRB Number
18814
Researcher
Frank Brescia
Keywords
Cancer, Cancer/Breast, Drug Studies
Summary

This study is being done to find out if adding trastuzumab to breast radiation therapy will be more effective than breast radiation therapy alone in preventing the occurrence of breast cancer in the same breast, in the other breast, or in other parts of the body.
Trastuzumab is called a targeted therapy because it targets breast cancers that make too much of a protein called HER2. Too much of the HER2 protein can cause cells to receive extra growth signals. Trastuzumab has been shown to block the HER2 protein and to slow down or stop the growth of HER2+ invasive breast cancers.
Patients will be randomized into one of two treatment groups. One group will receive radiation only, and the other group will receive Trastuzumab plus radiation therapy.

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

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