Masthead

Recently in Clinical Trials Category

MD Anderson experts share updates at AACR Annual Meeting

| Trackbacks (0)

The 54th annual meeting of the American Association for Cancer Research opens this morning in San Diego with educational sessions and workshops that cover issues ranging from cancer immunotherapy to clinical trial design to targeted therapy to clinical cancer genetics. And how to use Twitter to enhance and advance one's career.

The meeting April 5-9 will bring together about 18,000 cancer researchers, physicians, patient advocates and others from around the world to compare notes and learn the latest in preclinical, translational and early phase clinical research.

Sixteen MD Anderson scientists and physicians are chairing sessions and presenting state-of-the-art updates Saturday.

MD Anderson presentations (times, dates and place on the links):

Nicholas Navin, Ph.D., assistant professor of genetics, chairs a session titled Evolving Tumor Cell Populations: Dealth with Diversity and also will present Cancer evolution at single-cell genomic resolution

Stephanie Alexander, program director, Genitourinary Medical Oncology -- Research, will present Intravital microscopy of tumor invasion and therapy resistance at a methods workshop titled Intravital Imaging of Live Tumors at Single Cell Resolution in Real Time.

Cassian Yee, M.D., professor of Melanoma Medical Oncology, will present Adoptive T cell therapy  during an educational session about cancer immunology for the non-immunologist.

The U.S. Food and Drug Administration today approved ibrutinib as a single treatment for chronic lymphocytic leukemia patients with relapsed or resistant disease.

MD Anderson physicians have been instrumental in the development of the drug, known commercially as Imbruvica, which achieves higher response rates with milder side effects than established treatments for the disease.

They continue to lead clinical trials, including those for new combinations, and lab studies to better understand how ibrutinib works and how drug resistance develops.

"Ibrutinib has distinguished itself by producing durable responses in patients after other treatments have failed and with little toxicity.  The main side effect is mild diarrhea which usually resolves over time," says Susan O'Brien, M.D., professor of Leukemia, who led the phase I trial of the drug.

"This is an exciting time for CLL, with ibrutinib and other drugs in clinical trials providing new approaches that move us away from reliance of chemotherapy combinations," O'Brien says.

Milder than chemotherapy

Combinations of chemotherapy and the antibody rituximab have greatly extended survival for many patients in recent years. The standard-of-care combination known as FCR, developed at MD Anderson, puts about one third of patients in remission for 10 years or longer. Even so, chemotherapy side effects remain hard on patients and raise the risk they may develop second cancers down the line.

By Will Fitzgerald

In the largest expressive writing trial conducted on an oncology population, researchers from MD Anderson found those patients who recorded their deepest thoughts and emotions saw improved physical functioning and quality of life.
122264_Cohen_L.jpg

A cancer diagnosis may be experienced as a traumatic event causing depressive symptoms, sleep disturbance, fatigue and intrusive thoughts for patients.  Managing the response to these thoughts and symptoms is an important aspect of patient care because they affect quality of life.

Additionally, research has shown the poor management of these symptoms has the potential to elevate inflammation in the body, which can contribute to tumor progression.

The study, published in the Journal of Clinical Oncology, and led by Lorenzo Cohen, Ph.D., enrolled 284 patients diagnosed with stage I - IV renal cell carcinoma from 2006 - 2009. 

Patients were randomly assigned to either an expressive writing group (EW) or neutral writing group (NW).  Neutral writing included general thoughts about dietary behaviors, sleep and attitudes toward smoking, whereas expressive writing focused on a patient's deepest most personal thoughts. Patients in both groups were prompted to write on just four separate occasions.

Participants in both groups completed a series of questionnaires measuring intrusive thoughts, cancer-related symptoms (MDASI), fatigue (BFI), depressive symptoms (CES-D), sleep disturbances (PSQI) and overall quality of life (SF-36). 

Ten months after the intervention, where the most pronounced group differences occurred, MDASI scores were significantly lower for those in the EW group than NW group and the EW group reported better physical functioning aspects of quality of life.  

Fatigue levels were also moderately lower for those in the EW group compared to the NW group. At the one-month follow-up point, the data revealed patients in the EW group reported fewer intrusive thoughts compared to patients in the NW group, and this is what led to improvements in cancer-related symptoms and fatigue levels at 10 months. 

The authors note previous research on this subject primarily focused on women with breast cancer, however the findings suggest expressive writing could benefit men and women with different forms of disease.  They also note that considering the findings in light of an entirely self-administered, brief, safe, and virtually no-cost intervention, EW seems to be a promising supportive care approach. 

Additional work is needed to evaluate subgroups of patients, such as those lacking social support, who might see increased benefits.  Cohen said upcoming work related to the study will evaluate biologic markers including saliva and blood, to potentially establish bio-behavioral processes behind the outcomes.

For more information on other integrative medicine research and therapies benefiting physical, psycho-spiritual and social health, visit MD Anderson's Integrative Medicine Program.


Details Emerge In Link Between Body Mass Index, Chemotherapy Response

| Trackbacks (0)

By Will Fitzgerald

 

MD Anderson researchers discussed new data on the connection between body mass index (BMI) and response to presurgical chemotherapy in patients with inflammatory breast cancer during a poster discussion at the 36th annual CTRC-AACR San Antonio Breast Cancer Symposium,

 

130114Ueno.jpgThe study examined 1,002 cases of patients with inflammatory breast cancer or locally advanced non-inflammatory breast cancer between 2006-2012. It was the first to assess BMI association only in stage III locally advanced breast cancer, which includes inflammatory breast cancer, in contrast to previous research performed in early breast cancer for pathological complete response and survival outcome prediction.

 

BMI data was collected at breast cancer diagnosis and at the last cycle of chemotherapy and researchers compared the change in BMI value over the course of treatment.

 

Led by postdoctoral fellow Takahiro Kogawa, M.D., Ph.D., and Naoto T. Ueno, M.D., Ph.D., and Richard Theriault, D.O., both professors of Breast Medical Oncology, the study found an increase in BMI was associated with improved pathological complete response, especially in patients with normal BMI, a discovery that surprised researchers.

 

"This was a complete surprise because it goes against what we've known for a while that increased weight is often a negative factor," Ueno said.  "However, it's not conclusive at this point and we'll need to evaluate the data more carefully in addition to follow-up prospective studies."

Even as the targeted therapy ibrutinib makes its way through clinical trials as a single treatment for chronic lymphocytic leukemia (CLL), researchers are studying the new drug in combinations and identifying genomic changes that allow malignant cells to resist treatment.

Jan Burger, M.D., Ph.D., associate professor of Leukemia at The University of Texas MD Anderson Cancer Center, presented two such studies at the 55th Annual Meeting of the American Society of Hematology this month.

  • Combining ibrutinib with the targeted antibody rituximab resulted in complete or partial responses in 37 of 39 (95 percent)  high-risk CLL patients. At a median follow-up of 18 months, 31 patients (78 percent) remained on the drug with no sign of progression, with overall survival at 84 percent.
  •  Genomic analysis of CLL before treatment and after resistance so far point to mutations inside and outside the B cell receptor pathway targeted by ibrutinib as promoting resistance.

"This combination improves on the already excellent response rate from ibrutinib alone, which is usually around 70-80 percent.  It's also well-tolerated with manageable side effects and significantly improves patients' quality of life," Burger said.

 

100324_O'Brien_S.jpgPatients on an extended clinical trial of the targeted therapy ibrutinib have their relapsed or resistant chronic lymphocytic leukemia stymied even as side effects decline more than two years into the study.

 

Susan O'Brien, M.D., professor of Leukemia presented a poster updating trial results Monday evening at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition.

 

It was a busy day for MD Anderson investigators -- 21 faculty members conducted 25 oral presentations today in leukemia, lymphoma, stem cell transplantation and hemopathology.

 

Out of 140 patients in the phase II trial, 86 percent of those who were previously untreated had a partial or complete response to the oral drug while 88 percent of those with relapsed or treatment-resistant CLL also responded to ibrutinib. Progression-free survival at 30 months was 76 percent of patients.

"Among patients with relapsed or refractory CLL, it's really amazing that so many people would still be responding and on the drug well out over two years. This is a very exciting drug," says O'Brien.

Ibrutinib continues to be well-tolerated, with most patients staying on the drug until disease progression, O'Brien noted, rather than having to quit due to side effects or other complications. Ibrutinib does not cure CLL but cuts down the disease, halts progression and improves quality of life.

 

When it comes to equipping T cells, the immune system's attack dogs, to find and kill cancer cells, Sleeping Beauty just might be a heroine in the story.

Genetically altering T cells to recognize a surface protein called CD19 and destroy cells that wear it has shown great promise for treating blood cancers, most recently in clinical trials presented during this week at the 55th American Society of Hematology (ASH) Annual Meeting in Exposition, now under way in New Orleans.

 

Encouraging early results from the first clinical trials of T cells modified by gene transfer using the Sleeping Beauty transposon to deliver a genetic package that creates an anti-CD19 receptor on T cells were reported Sunday night at ASH.

"Five months into these clinical trials, no acute or late toxicities have been noted from treatment with genetically modified chimeric antigen receptor (CAR) T cells in nine patients after they received blood stem cell transplantation," says Partow Kebriaei, M.D., associate professor of Stem Cell Transplantation and Cellular Therapy.

"Delivering CAR T cells after transplant targets minimal residual disease in hopes of maintaining remission for people with high-risk B cell malignancies," Kebriaei says.

Of the first five patients with acute lymphoblastic leukemia, three treated with the initial, minimal T cell dose had their disease progress while the first patient treated at the next highest dose remains in remission. It was too early to evaluate the fifth, who received an umbilical cord blood transplant.

Four non-Hodgkin lymphoma patients treated with the higherT cell dose all remained in remission after three months. Eventually, 25 patients will be treated in the clinical trial.

The U.S. Food and Drug Administration today approved ibrutinib for treatment of patients with mantle cell lymphoma who have received at least one other form of therapy.

Approval came under the FDA's accelerated approval program for potential breakthrough drugs based on a single-arm pivotal phase II clinical trial led by Michael Wang, M.D., professor of Lymphoma/Myeloma.

new wang photo.jpg "This is excellent news for mantle cell lymphoma patients," Wang says. "Ibrutinib is an oral drug taken once daily that has shown better response rates for patients than existing combination chemotherapy regimens and with much milder side effects."

Wang and colleagues reported clinical trial results in the New England Journal of Medicine on June 19.

The FDA announcement noted that the international clinical trial enrolled 111 patients and demonstrated a 66% overall response rate, with 17% of patients achieving a complete response and 49% partial responses.  Median response duration was 17.5 months. Approval was based on overall response rate; a survival advantage has not yet been established.

Seventy-seven patients had stage 4 disease entering the trial and the median number of previous treatments received was three.

Oral cancer patients with tumors at the back of the throat are half as likely to require a feeding tube when treated with intensity modulated proton therapy (IMPT) compared to patients treated with intensity modulated radiation therapy (IMRT), an MD Anderson study has found. 

 

IMPT, one of the most advanced forms of proton therapy, delivers a precise dose of protons to tumors embedded in the "nooks and crannies" of the head and neck, including oropharyngeal carcinoma, which occurs at the base of the tongue and tonsils.

 

Unlike IMRT, which destroys both cancerous and healthy cells, IMPT destroys cancer cells while sparing surrounding healthy tissue from damage and, simultaneously, preserving important quality-of-life factors such as neurocognitive function, vision, swallowing, hearing, taste and speech.

 

The American Cancer Society estimates that 36,000 people in the U.S. are diagnosed with oropharyngeal cancer each year (approximately a 20% increase since 2010).  Nearly 70% of cases are HPV (human papilloma virus) - positive.

 

Of the 50 patients enrolled in the study:

 

·         Twenty-five were treated with IMPT and 25 received IMRT.

·         Five patients treated with IMPT required the use of feeding tubes (20%) compared to 12 patients treated with IMRT (48%).

·         IMPT patients were spared from serious side effects usually caused by IMRT such as vomiting, nausea, hearing problems, and mucositis (inflammation and ulceration of the digestive track).

·         IMPT patients also could better sustain their nutrition and hydration levels, often leading to faster recovery during and after treatment.

 

Joining a clinical trial to prevent breast cancer recurrence

| Trackbacks (0)

 

 

I finished the most active treatment phase for male breast cancer in the first week of June, enjoyed a few weeks off from regular clinic visits and am now back to join a clinical trial that I hope will help me stay disease free and make a contribution to the development of a new therapy to suppress breast cancer recurrence. 

 

The trial is testing a relatively new approach, in which the immune system is trained to keep a watchful eye out for breast cancer cells. It is part of the exciting new breakthroughs that have occurred in the last few years, which are beginning to fulfill the promise of harnessing the immensely powerful immune system for the fight against cancer. One of the big challenges has been identifying the right way to train the immune system, both in terms of providing it the right target, and in knowing how to get it into high gear.

 

The trial I am joining was designed by Beth Mittendorf, M.D., in Breast Medical Oncology, who recently spoke about her work in an interview at ASCO.

 

Anatomy of a clinical trial

 

It is called "Prospective Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/neu Peptide AE37 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2- Node Positive and High Risk Node-Negative Breast Cancer Patients to Prevent Recurrence." 

 

That's quite a mouthful - it's almost a summary of the whole trial! Let's break it down.  

Search

Cancer Frontline on Twitter