Tag: cancer clinical trials

New Clinical Trial: A Phase II Trial of PET-Directed Therapy for Limited Stage DLBCL

The Weill Cornell Lymphoma Program has recently opened a new clinical trial for men and women with Diffuse Large B-cell Lymphoma (DLBCL). The study sponsor is the Southwest Oncology Group, and the principal investigator at Weill Cornell is Peter Martin, M.D.. For more information about the study, please call Amelyn Rodgriguez, RN at (212) 746-1362 or e-mail Amelyn at amr2017@med.cornell.edu.

Key Eligibility

  • Men and women age 18 years and older
  • Patient must have biopsy proven diffuse large B-cell lymphoma
  • Patient cannot have received prior chemotherapy, radiation, or antibody therapy for lymphoma
  • Detailed eligibility reviewed when you contact the study team

Study Details 

This phase II trial studies how well PET-directed chemotherapy works in treating patients with limited-stage diffuse large B-cell lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone, work in different ways to stop cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Comparing results of diagnostic procedures, such as PET scan and CT scan, done before, during, and after chemotherapy may help doctors predict a patient’s response to treatment and help plan the best treatment.

Primarily, this study will assess the 5 year progression- free survival (PFS) rate in patients with newly diagnosed limited-stage diffuse, large B-cell lymphoma (DLBCL) using positron emission tomography (PET)/CT scan to direct therapy after 3 courses of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP).

Patients will be stratified according to whether the patient was upstaged to advanced stage DLBCL, based on local review of the baseline PET/CT (yes vs no).

  • Chemotherapy: Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV over 30-60 minutes, vincristine sulfate IV, and doxorubicin hydrochloride IV on day 1, and prednisone orally on days 1-5. Treatment repeats every 21 days for 3* courses. NOTE: *Patients found to have advanced stage DLBCL based on local review of the baseline PET scan receive 6 courses of R-CHOP.
  • FDG/PET – Radiotherapy: Patients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan at baseline, on days 15-18 of course 3, and at 12 weeks after completion of course 3. Patients with complete response (PET scan negative) receive one additional course of R-CHOP as above. Patients with partial response (PET scan positive) undergo involved-field radiotherapy (IFRT) 5 days a week for approximately 4-5 weeks.
  • Monoclonal antibody: Beginning 3-6 weeks after completion of IFRT, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes and rituximab IV on day 1 and on day 7, 8, or 9.
  • Patients may undergo blood sample collection at baseline for correlative studies. Bone marrow tissue samples may be also collected for correlative studies.
  • After completion of study therapy, patients are followed up every 6 months for 2 years and then yearly for 5 years.

Clinical Trials or Standard Treatment? Understanding Options for Blood Cancers

On March 18, 2015 Lymphoma Program Director, Dr. John Leonard presented a brief program with the LLS entitled, “Clinical Trials or Standard Treatment? Understanding Options for Blood Cancer“. The program covered:

  • The role of clinical trials in blood cancer treatment
  • How clinical trials are designed.
  • How to determine the best treatment options for patients
  • Talking to your healthcare team about treatment options

An audio recording of the presentation is available along with program slides and and a transcript of the presentation.

Dr. John Leonard Comments on Fox 5 News Regarding the Importance of Clinical Trials

Via the Meyer Cancer Center.

Recently Fox 5 News interviewed Lymphoma Program director, Dr. John Leonard about patient participation in clinical trials. As the director of the Joint Clinical Trials Office at Weill Cornell Medical College and NewYork-Presbyterian Hospital, Dr. Leonard is an expert in all questions relating to clinical trials. In the video Dr. Leonard cautioned that,

“…finding patients for clinical trials is often about numbers not money. Dr. Leonard says his office is trying to get the word out and let more patients know that clinical studies are out there that than can potentially help them.

Dr. Leonard’s office focuses on finding more effective treatments for serious illnesses like cancer and neurological disorders. He says it is a great opportunity for patients to gain access to the newest treatments before they’re available to anyone else.

Dr. Leonard has personally treated patients on clinical trials who have been among the first people to ever get a drug, and also among the first people to be effectively treated, cured, or had a better outcome because they participated in a clinical trial.

Remember, there is a big difference between answering an online ad for a medical study and going to a reputable institution like Weill Cornell Medical College or New York Presbyterian Hospital.

You can see plenty of cautionary tales online from people who signed up for studies online and gave their personal information only to find out that study was a scam designed to get and sell that personal information to marketers.

If you think a clinical trial might work for you, Dr. Leonard suggests contacting your physician.”

If you are interested in participating in a clinical trial for patients with lymphoma at Weill Cornell Medical College please click on the link.

Dr. John Leonard can be followed on Twitter @JohnPLeonardMD.

The Lymphoma Program can be followed on Twitter @lymphomaprogram.