Clinical Trials - NCCC : NCCC

Clinical Trials

Before a treatment regimen can become standard, it must go through a clinical trial. Clinical trials test if a potential treatment is safe and effective in humans. Clinical trials go through a series of phases, starting with a smaller group of patients and expanding to a much larger group. The video below explains the three main phases of a clinical trial.



Most cancer-related clinical trials involve possible new treatments, including vaccines, surgical approaches, and immunotherapy (using the patient’s own immune system to fight the cancer).

Benefits and Risks

For some patients, a clinical trial may be the best treatment option, but any patient should carefully measure the risks and benefits involved. It’s important to understand what a clinical trial is, what your rights are as a patient, and what the risks and benefits are before making a decision. The National Institutes of Health, lists the following benefits and risks of trial participation:

Benefits:

  • Play an active role in your own health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading health care facilities during the trial.

Risks:

  • There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
  • The experimental treatment may not be effective for the participant.
  • The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

Before entering a clinical trial, a patient will go through the process of informed consent where they are informed of the risks and benefits specific to that trial, as well as complete details of all the tests, treatments, and procedures involved. The patient will also learn about their rights, including the right to withdraw at any time.

Cervical Cancer Clinical Trials

Clinical trials are not limited to new cervical cancer treatment options—researchers are also looking at cervical cancer prevention, diagnosis, palliative care (support and symptom management), as well as psychosocial issues related to cancer. ClinicalTrials.gov, a service of the National Institutes of Health, offers an extensive list of clinical trials as well as detailed information on the trial, including criteria for patients to qualify.

Below are a sampling of clinical trials that are currently recruiting new participants, to offer an idea of the type of research currently underway. ClinicalTrials.gov also offers information on trials that have been completed, along with results from those trials.

Prevention and Diagnosis
Screen and early detection is an important aspect of cervical cancer prevention. These two trials are looking at ways to reach women who may not be screened regularly by enabling women to collect cervical samples at home and submit these for evaluation and diagnosis.

Treatment
New research into cervical cancer treatment includes immunotherapy—boosting the body’s immune system to aid it in fighting disease—and targeted therapy—identifying specific targets, such as genes or proteins, in cancer cells to stop their growth and spread.

  • Study of ADXS11-001 in Subjects With High Risk Locally Advanced Cervical Cancer (AIM2CERV)
    For patients with high-risk locally advanced carcinoma of the cervix (HRLACC) following concurrent chemotherapy and radiation therapy. The estimated probability of disease recurrence or death within 4 years of diagnosis is 50% and the prognosis is very grave for those who experience a recurrence. The purpose of the study is to compare the disease free survival of ADXS11-001 to placebo administered following concurrent chemotherapy and radiation therapy with curative intent in subjects with HRLACC.
  • Study of LN-145, Autologous Tumor Infiltrating Lymphocytes in the Treatment of Patients With Cervical Carcinoma
    LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with recurrent, metastatic, or persistent cervical carcinoma. The cell transfer therapy used in this study involves patients receiving a NMA lymphocyte depleting preparative regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2.
  • NCI-MATCH: Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma
    This phase II trial studies how well treatment that is directed by genetic testing works in patients with solid tumors or lymphomas that have progressed following at least one line of standard treatment or for which no agreed upon treatment approach exists. Genetic tests look at the unique genetic material (genes) of patients’ tumor cells. Patients with genetic abnormalities (such as mutations, amplifications, or translocations) may benefit more from treatment which targets their tumor’s particular genetic abnormality.

Palliative Care

  • Effect of Outpatient Symptom Management on Gynecologic Oncology Patients Receiving Chemotherapy
    Patients with gynecologic malignancies often have a high prevalence of symptoms throughout their disease course including fatigue, pain, anxiety and depression. Palliative care is defined by the World Health Organization (WHO) as “an approach that improves the quality of life of patients and their families facing the problems associated with life threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual.” This study will provide a screening mechanism to identify advanced stage or recurrent gynecologic oncology chemotherapy patients with palliative care needs and determine which symptom management option provides the best improvement in symptom burden, that performed by a specialty clinic staffed by providers formally trained in palliative care or that provided by the patient’s gynecologic oncologist.
  • Palliative Care in Improving Quality of Life in Patients With High Risk Primary or Recurrent Gynecologic Malignancies
    This randomized clinical trial studies a palliative care program in improving the quality of life of patients with high-risk gynecologic malignancies. Palliative care is care given to patients and their families facing the problems associated with life-threatening illness, through the prevention and relief of suffering by means of early identification and impeccable assessment and treatment of pain and other problems, physical, psychosocial and spiritual. Studying a palliative care program may help doctors learn more about patients quality of life, use of healthcare services, and the relief of pain.

Psychosocial Issues

  • Psychosexual Intervention in Patients With Stage I-III Gynecologic or Breast Cancer
    This randomized phase II trial studies how well psychosexual intervention works in patients with stage I-III gynecologic or breast cancer. Psychosexual intervention may improve sexual and psychosocial function. Patients are randomized to 1 of 2 arms. ARM I (Enhanced standard care): Patients participate in enhanced standard care intervention comprising stress reduction, information delivery regarding gynecologic or breast cancer treatments and sexuality, and provision of a survivorship care plan. ARM II (Psychological intervention): Patients participate in individual or group therapy and complete assessment interviews.

Clinical Trial Resources

  • Information on clinical trials, including a search tool and live chat line, from the National Cancer Institute
  • Taking Part in Cancer Treatment Research Studies. This booklet book explains cancer treatment clinical trials and gives you some things to think about when deciding whether to take part.
  • ClinicalTrials.gov. A service of the U.S. National Institutes of Health, this site allows you to search for clinical trials for any condition.
  • MedlinePLus, from the US National Library of Medicine, offers an overview of clinical trials along with a load of links to more information
  • A glossary of terms related to clinical trials

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