Below are two new clinical trials for breast and lung cancer. Read more about each clinical study being offered at the Johns Hopkins Kimmel Cancer Center and the criteria for eligible participants.
A clinical trial for rectal cancer patients will test a technique that delivers high doses of radiation directly to rectal tumors.
The study will evaluate the effectiveness of endorectal brachytherapy (EBT) in patients with stage II and III low rectal cancers, with tumors less than 12 centimeters from the anus.
Who Can Join?
Eligible rectal cancer patients may include those with:
- Stage II and III rectal cancer
- Rectal cancer that has not spread to other parts of the body
What is involved in the clinical trial?
As part of the experimental treatment, patients will receive four days of EBT before surgery, in contrast to the standard treatment of 28 days (over five to six weeks) of external (X-ray) beam- radiation therapy and chemotherapy delivered before surgical removal of the tumor.
EBT uses a wire containing a high-dose radiation source threaded through a cylinder-shaped applicator inserted into the patient’s rectum. As the radiation moves slowly through the applicator, the wire delivers a high dose of focused radiation to the surface of the tumor. Normal tissue farther away from the applicator, including the bladder, small intestine and reproductive organs, receives a lower dose than with standard “long-course” radiation therapy. The treatment is delivered for 15 minutes a day over four days, and radiation sources are completely removed from the body at the end of each session. Patients have a six-to-eight-week recovery period following EBT before they undergo surgery.
This study is funded by NucletronTM.
For more information or to see if you qualify, call Beth Griffith at 410-502-9243 or email email@example.com.
Epigenetic Therapy for Patients with Surgically Resected Early Stage Lung Cancer
Traditionally, patients with early stage lung cancer have been monitored with CT screenings to see if the cancer returns, there have been no additional treatment options for surgery. Now, at Johns Hopkins, there is a new therapy that is being investigated for patients after surgery. This new treatment utilizes epigenetic therapy in the treatment of early stage lung cancer.
The experimental use of epigenetic therapy after surgery is being compared to the current standard of care which is supportive care after surgery for patients diagnosed with Stage 1 Non-Small Cell Lung Cancer (NSCLC).
What is Epigenetic Therapy and How is it Different?
Epigenetic therapy represents a novel concept in treating cancer. It has not been FDA-approved for the use in lung cancer. The doses of the drugs given are lower than the maximally tolerated doses of these drugs, which may limit the toxicity.
The goal of this type of therapy is not to kill the cancer cells directly. Instead, the objective is to allow the cells to live to absorb the drugs. The drugs then change the cancer cells from the inside out, making them a more normal cell. Since the Epigenetic Therapy is given in a low does, it has fewer side effects than standard chemotherapy.
Who Can Join?
Eligible participants may include those with:
- Patients that have received complete resection of pathologically proven NSCLC (stage 1A or 1B).
- Must be between 4-8 weeks out from surgery.
- Must be older than 18 years of age.
- Must not have received any chemotherapy or radiation therapy for your lung cancer.
- Must have acceptable lab values and assessed to be in a good state of health.
What is Involved?
- Eligble patients will be randomized to epigenetic treatment consisting of two drugs; 5-Azacitidine & Entinostat or standard of care
- All patients will need to spit into a cup, have blood samples drawn, and receive physical examinations as well as radiological imaging.
- Patients that are randomized to epigenetic treatment will receive subcutaneous injections in the outpatient setting on days 1-5 and 8-10, and an oral agent on days 3&10 of each 28-day cycle. Up to 6 cycles of treatment will be given.
- Patients randomized to standard of care will be followed with CT screenings and collections of research labs every 3 months for the first 2 years and then every 6 months after that.
For More Information
If you think this trial may be right for you, contact us. We will help determine if you may be eligible for the trial and answer any questions.
Joanne Riemer, RN
443-287-4114 - firstname.lastname@example.org
Malcolm Brock, M.D.
410-955-8506 - email@example.com
Charles Rudin, M.D.
410-502-0678 - firstname.lastname@example.org
Beverly Lee/Kristen Rodgers
This study is funded by Stand Up 2 Cancer
For more information or to see if you qualify, call 410-955-8804 or email HopkinsBreastTrials@jhmi.edu.
A new clinical trial for breast cancer patients will test the effects of two drugs, called 5-Azacitidine (5-AZA) and Entinostat. Preliminary results from clinical trials at Johns Hopkins in cancers other than breast cancer indicate that this combination is safe and tolerable and associated with improved outcome for certain patients. The drugs are believed to work by targeting specific changes that occur in important breast cancer genes.
Who can Join?
Eligible participants may include those with:
- a diagnosis of triple negative breast cancer
- hormone-resistant (HER2-negative) breast cancer
- advanced breast cancer, or inoperable breast cancer
- metastatic breast cancer
In addition, patients must have measurable disease that can be biopsied prior to and during the trial, and be in good health. 5-Azacitidine is given by injections and an Entinostat pill is taken orally at Johns Hopkins or a participating site eight days each month over a 10-day period. Patients with progressive disease may continue the drugs in combination with hormonal therapy, such as tamoxifen or letrozole, at the discretion of the treating physician.
To find out if you may be eligible, call the Clinical Trials Line at the Johns Hopkins Kimmel Cancer Center at 410-955-8804 or email HopkinsBreastTrials@jhmi.edu. To locate a center near you, visit clinicaltrials.gov trial identifier: NCT01349959
Johns Hopkins IRB-Approved Study #NA_00046053