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Clinical Trials

The goal of a clinical trial is to find a better way to treat cancer and help patients. The trials test various treatment options, including new drugs, new approaches to surgery or radiation therapy, new combinations of treatments, or new methods, such as gene therapy.  Search our database of clinical trials at the Johns Hopkins Kimmel Cancer Center.

With unparalleled expertise in pancreas cancer care, our experts offer the most advanced knowledge through promising clinical trials tailored to each patient’s care. We offer clinical trials not only with therapies made by pharmaceutical and biotechnology companies, but, also with experimental therapies developed by Johns Hopkins pancreas cancer physician-scientists and laboratory researchers.

Johns Hopkins Kimmel Cancer Center investigators are leaders in setting new standards for pancreas cancer care. Advances in clinical care are made by conducting research that tests novel therapies.

Our physicians currently are participating or leading numerous clinical trials concerning various aspects of pancreas cancer. Each study has its own guidelines for who can participate. Study participants generally are grouped according to their similarities, such as the type and stage of cancer, age, gender, or previous treatments.

Pancreatic Cancer Clinical Trial Summaries (February 2012)

Neoadjuvant/Adjuvant (Resected Cancer)

Study Number: J0810
Status: Open
PI: Dr. Dan Laheru/ Dr Lei Zheng
Research Nurse/study contact: Carol Judkins
Email: judkica@jhmi.edu
Phone: 410-614-5241

Summary: This study builds upon previous work testing a pancreatic cancer vaccine integrated around chemoradiation for patients with resected pancreatic cancer. This study looks to combine a drug (Cytoxan) that may enhance the effectiveness of the vaccine. We are testing the best way to give the cytoxan with the vaccine. The first vaccine will be given prior to surgery so that we can look at the effects of the immune system in and around the pancreatic tumor. Following surgery patients will receive a second vaccine, will then complete planned chemoradiation/chemotherapy which will take about 6 months, and then receive 4 additional vaccines at monthly intervals. Patients who complete this study will have the option of enrolling into a follow-up long term boost vaccine study (J09110).

Adjuvant (Resected Cancer)

Study Number: J09100
Status: Open
PI: Dr. Dan Laheru/ Dr Lei Zheng
Research Nurse/study contact: Carol Judkins
Email: judkica@jhmi.edu
Phone: 410-614-5241

Summary: Patients who have completed J0810 will have the option of continuing scheduled boost vaccines at 6 month intervals. This study will also consider patients who did not participate in J0810 but who have had surgery and adjuvant chemoradiation/chemotherapy and who are still cancer free.

Borderline Resectable Pancreas Cancer

Study Number: J1130
Status: Open
PI: Dr. Ana De Jesus
Research Nurse/study contact: Dionne Savage
Email: dsavage3@jhmi.edu
Phone: 410-614-0382

This study investigates the use of a new class of drug called Hedgehog signaling integrated with Gemcitabine in patients as upfront treatment for 4 months with borderline resectable pancreas cancer. Hedgehog signaling is thought to be important in cancer cell growth and maintenance of the pancreatic cancer local environment known as the stroma. This stroma is thought to be tumor protective and not allow the effective penetration of chemotherapy into the tumor. We will look at how the drug delivery of gemcitabine to the tumor is changed with the addition of a hedgehog inhibitor.  The phase II component of this study is a randomized 1:1 design with half of patients receiving gemcitabine + LDE225 and the other half of patients receiving gemcitabine alone prior to planned surgery.


Locally advanced unresectable

Study Number: J1003
Status: Open
PI: Dr. Joe Herman
Research Nurse/study contact: Beth Griffith
Email: bgriffit@jhmi.edu
Phone: 410-502-9243

Summary: For patients with locally advanced unresectable cancer, many patients will be recommended treatment with combined chemotherapy and radiation therapy with plan to keep the cancer from growing/spreading or in the best of circumstances to try and decrease the size of the tumor so that surgeons can consider surgery. Most radiation treatments require 5.5 weeks. This study administers a stereotactic radiation (cyberknife) which allows a more focused treatment. The study gives one month of gemcitabine as upfront therapy followed by cyberknife radiation therapy administered over 5 treatments. Following completion of cyberknife patients will continue on gemcitabine based chemotherapy.

Metastatic Cancer

First Line Treatment

Study Number: J0950
Status: Open
PI: Dr. Dan Laheru
Research Nurse/study contact: Dionne Savage
Email: dsavage3@jhmi.edu
Phone: 410-614-0382

Summary: A recent multi-institutional study demonstrated that a combination of Gemcitabine + Nab-Paclitaxel (Abraxane) is safe and is an effective combination. This study looks to demonstrate this effect in a randomized phase III International study. Every patient will receive Gemcitabine as this treatment is still considered an appropriate treatment. Half of the patients will receive Gemcitabine and Abraxane. This is not a placebo based study in that every patient will know if they are receiving Abraxane or not.

Study Number: J1013
Status: Open
PI: Dr. Dan Laheru/Dr. Ana De Jesus
Research Nurse/study contact: Roz Walker
Email: rwalker3@jhmi.edu
Phone: 410-955-9629

Summary: This study investigates the use of a new class of drug called Hedgehog signaling integrated with Gemcitabine + Nab-paclitaxel (abraxane). Gemcitabine + abraxane is not an approved treatment for metastatic pancreas cancer but there is some early studies which demonstrated that this could be an effective combination upon which to build new treatments. Hedgehog signaling is thought to be important in cancer cell growth, maintenance of the pancreatic cancer local environment known as the stroma, maintenance of an early pancreatic cancer cell population known as stem cells, and possibly an important mediator of pancreatic cancer immunology. The study will use a Hedgehog inhibitor developed by Genentech (GDC0449). This study is supported through our Stand Up to Cancer (SU2C) program grant.

Study Number: J11125
Status: Open
PI: Dr. Dung Le
Research Nurse/study contact: Katrina Purtell
Email: kalino1@jhmi.edu
Phone: 410-955-9629

Summary: This study investigates combinations of drugs when the patients are most likely to tolerate therapy and to decrease the likelihood of developing resistant clones which is more likely to occur when drugs are given sequentially. The choice of GTX as a backbone is based on collective experience with this regimen and its promise in phase II studies. It has been observed that despite multiple dose reductions, usually due to bone marrow toxicity and not clinical symptoms, many patients still have a prolonged response to therapy, suggesting that with multi-agent chemotherapy, maximal doses are not necessary to show a continued effect. Using lower doses of GTX will allow us to test the hypothesis that adding cisplatin to this multi-agent regimen will be safe and improve efficacy. Cisplatin is chosen based on the following observations: (1) cisplatin is a DNA intercalating agent which works through a different mechanism than gemcitabine, taxotere, or xeloda; (2) pancreatic cancers with defects in BRCA/Fanconi DNA repair pathway are sensitive to cisplatin; (3) meta-analyses suggest that gemcitabine/platinum combinations improve survival in good performance status patients.


Second Line Treatment

Study Number: J1149
Status: In review
PI: Dr. Dung Le
Research Nurse/study contact: Beth Onners
Email: onnerbe@jhmi.edu
Phone: 410-502-2800


Summary: This study uses the pancreatic cancer vaccine that has been developed at Johns Hopkins. We are investigating approaches to combine antigen presentation approaches. This is a Phase 2, Randomized, Multicenter, Open-Label Study of the Efficacy and Immune Response of the Sequential Administration of GVAX Pancreas Vaccine (with Cyclophosphamide) Alone or Followed by CRS-207 in Adults with Metastatic Pancreatic Adenocarcinoma

Study Number: J1095
Status: Open Dec 2010
PI: Dr. Dan Laheru
Research Nurse/study contact: Sheila Linden
Email: slinden2@jhmi.edu
Phone: 410-614-4397


Summary: This study investigates the hypothesis that there might be better circumstances in which gemcitabine works. Gemcitabine requires a transport protein (hENT-1) to carry the drug across the plasma membrane into the cell where it can affect cancer growth. There is some recent data suggesting that the absence of this transport protein adversely affects the effectiveness of this drug. This study looks at a lipid modified Gemcitabine that can bypass this transport protein. Ths study would be open for patients whose tumors do not express this transport protein.

Study Number: J1065
Status: Open early 2011
PI: Dr. Dan Laheru
Research Nurse/study contact: Gina Norton
Email: rnorton1@jhmi.edu
Phone: 410-614-5948

Summary: this study investigates an important pathway in pancreatic cancer cell growth called NOTCH signaling. This study uses an oral agent Gamma Secretase Inhibitor RO4929097


Study Number: J1070
Status: Open
PI: Dr. Mike Goggins
Research Nurse/study contact: Gina Norton
Email: rnorton1@jhmi.edu
Phone: 410-614-5948

Summary: In the laboratory, pancreatic cancers with genetic defects in the BRCA/Fanconi DNA repair pathway are sensitive to a new class of drugs known as PARP inhibitors (an example of a PARP inhibitor is the drug that we are testing in this study olaparib) and to DNA intercalating agents such as mitomycin C and cisplatin. Early clinical trials indicate that patients with BRCA deficient cancers respond to PARP inhibitors. Patients with familial pancreatic cancer and Jewish patients with pancreatic cancer are more likely than sporadic pancreatic cancer patients to have defects in the BRCA/Fanconi pathway.  Combining olaparib with a chemotherapy regimen of Irinotecan, Cisplatin and Mitomycin C (ICM) is hypothesized to prevent resistance to the PARP inhibitor.

Clinical Care Studies

Management of cancer associated ascites

Study Number: J0940
Status: Open
PI: Dr. Ana De Jesus
Research Nurse/study contact: Sheila Linden
Email: slinden2@jhmi.edu
Phone: 410-614-4397


Summary: The management of patients who develop accumulation of fluid in the abdomen (ascites) is very challenging. Often this treatment includes restriction of sodium, diuretics, manual removal of fluid (paracentesis) and more recently the placement of an abdominal cathether (pleurx catheter). There are risks of placing an abdominal catheter including infection. Often the pleurx catheter is placed once other treatment approaches have not worked. The benefit of such a device early in management is not clear. This study investigates whether a pleurx catheter should be integrated earlier in the care of patients with ascites. Patients will be randomized to receive standard treatment (diuretics, paracentesis) or pleurx cathether. If patients on the standard treatment are ultimately are thought to need a pleurx catheter, this will be placed for them. The study will pay for the costs of the catheter. The definition of recurrent/refractory malignant ascites for this study:
1. Symptomatic ascites that recurred after one paracentesis in a patient with known malignant ascites.
2. Removal of at least 5 L in the preceding two months for symptoms relief


 

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