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Neurofibroma clinical trials

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NCT ID: NCT01702922 Completed - Clinical trials for Parents of Children With Cancer

Relationship Stressors in Parents of Children With Cancer or Neurofibromatosis Type 1 (NF1)

Start date: September 13, 2012
Phase:
Study type: Observational

Background: - Serious illnesses like cancer or Neurofibromatosis Type 1 (NF1), can cause high levels of stress in a family. When a child is diagnosed with cancer or NF1, parents face numerous stressors, each of which can strain relationships. Many parents struggle to effectively cope with the changes in parenting roles that often accompany treatment of childhood cancer or NF1. How parents cope with this stress can influence whether the relationship is strengthened or weakened. Stress levels can also affect the care of the child who has cancer or NF1. Researchers want to better understand the critical time points and events during the child s treatment when the relationship becomes most stressed and/or strengthened. Objectives: - To study how stress affects the relationship between parents who have a child with cancer or Neurofibromatosis Type 1 (NF1). Eligibility: - Parents of a child (between 1 and 24 years of age) who has been diagnosed with cancer or NF1. - Participants must have been in a partnership at the time the child was diagnosed with cancer or NF1. At least one of the parents must be a biological or legal parent of the child. Design: - Participants will fill out a questionnaire either online or by paper and pencil. It will take about 20 minutes to complete. The questions ask about the experience of dealing with a child s cancer OR NF1 diagnosis and how it affects participants relationship with their spouse/partner. - Some participants will also have an in-depth interview. It will last about an hour. It will ask further questions about the cancer OR NF1 diagnosis and treatment and its effect on the relationship. - Treatment will not be provided as part of this study.

NCT ID: NCT01682811 Completed - Neurofibromatoses Clinical Trials

Phase I Photodynamic Therapy (PDT) for Benign Dermal Neurofibromas (NF1)

Start date: March 12, 2012
Phase: Phase 1
Study type: Interventional

GENERAL OBJECTIVE The general objective is to assess the safety and efficacy of photodynamic therapy (PDT) in the treatment of neurofibromatosis 1 (NF1) tumors in the skin. SPECIFIC OBJECTIVE This is a light dose escalation pilot study to determine the safety and efficacy of PDT using 5-aminolevulinic acid (ALA) and 633 nm light in the treatment of benign dermal neurofibromas. Specifically, the primary goal of the current study is to determine the maximum tolerable light doses that can be administered to subjects undergoing topical photoillumination photodynamic therapy with standard application of Levulan Kerastick (ALA) for Topical Solution.

NCT ID: NCT01673009 Completed - Neurofibromatosis Clinical Trials

Phase II Study of Gleevec/Imatinib Mesylate (STI-571, NCS 716051) in Neurofibromatosis (NF1) Patients With Plexiform Neurofibromas

Start date: May 2006
Phase: Phase 2
Study type: Interventional

THe primary objective is to estimate the response rate at 6 months to Gleevec® in patients with plexiform neurofibromas

NCT ID: NCT01653028 Completed - Clinical trials for Recurrent Adult Soft Tissue Sarcoma

Alisertib in Treating Patients With Advanced or Metastatic Sarcoma

Start date: August 22, 2012
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well alisertib works in treating patients with sarcoma that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has spread to other places in the body (metastatic). Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT01639950 Completed - Leukemia Clinical Trials

Validating Pain Scales in Children and Young Adults

Start date: August 6, 2012
Phase:
Study type: Observational

Background: - Assessing pain levels is important to improve treatments for different illnesses. Most pain rating scales are used to determine pain levels in adults. Pain is also a common symptom among children who have cancer. Those who have genetic conditions that may lead to cancer may also have pain symptoms. However, the pain scales used for adults have not been fully tested in children and young adults. As a result, they may not be as accurate. Researchers want to test pain rating scales in children and young adults who have cancer and genetic conditions that can lead to cancer. Objectives: - To study the effectiveness of pain rating scales given to children and adults with Sickle Cell Disease (SCD),cancer, and related genetic conditions. Eligibility: - Adults 18 and 34 years of age and older who have SCD, cancer, or other genetic conditions that can lead to cancer. Design: - Participants with SCD, cancer or related genetic conditions will fill out four questionnaires. These questionnaires will ask about pain levels and how much pain interferes with daily life. - Pain treatments will not be provided as part of this study.

NCT ID: NCT01633008 Completed - Neurofibromatosis Clinical Trials

Acceptance and Commitment Therapy for Adolescents and Young Adults With Neurofibromatosis and Chronic Pain

Start date: June 15, 2012
Phase: Early Phase 1
Study type: Interventional

Background: - Neurofibromatosis type 1 (NF1) is a genetic disorder that can cause frequent and significant pain. This pain can have a severe impact on a person s quality of life. - Acceptance and Commitment Therapy (ACT) is a new type of therapy that may help people manage pain. It teaches behavioral techniques that can be used to change how people react to pain. ACT may help people with NF1 cope better with the pain associated with the disorder. Researchers want to test ACT techniques to see if they can improve coping in people with NF1 pain. Objectives: - To see if ACT can help treat chronic pain in adolescents and young adults who have NF1. Eligibility: - Adolescents and young adults between 12 and 21 years of age who have chronic pain associated with NF1. Design: - Participants will be screened with a physical exam and medical history. They will also complete a set of questionnaires about their pain levels, quality of life, and medications that they are taking. - Participants will take part in a training workshop for ACT. It will consist of three 2-hour sessions over 2 consecutive days. The workshop will teach techniques for setting goals that reflect personal values, and changing the focus from pain avoidance to pain management. There will be practice exercises between each session. - At the end of the workshop, participants will receive a workbook with the exercises to continue to practice at home. Participants will be encouraged to spend at least 20 minutes, three times per week, on these practice exercises. - There will be a followup phone call to check on pain management after the workshop. - Three months after the first study visit, participants will complete the study questionnaires again from home. They will provide more information about how they are managing their pain. The questionnaires will be returned by mail in an envelope provided by the study team.

NCT ID: NCT01595139 Completed - Glioma Clinical Trials

MicroRNAs in Patients With Neurofibromatosis Type 1

Start date: February 2012
Phase: N/A
Study type: Observational

MicroRNAs are small molecules which have recently been discovered in cells. They are known to be responsible for the normal development of cells and when they are disrupted can contribute to the development of cancer. Many previous studies have been done evaluating the expression of microRNAs in normal tissues as well as in a wide variety of cancers. Recently, microRNAs from tumor cells have been detected circulating in the blood of patients with cancer. This presents a novel opportunity to assess the utility of microRNAs in the blood as an early predictor of cancer as well as a marker of response to therapy. No previous studies have been performed evaluating microRNAs in archived tumor tissue and blood of patients with Neurofibromatosis type 1 (NF-1). The investigators propose a feasibility study to evaluate the presence of microRNAs in archived tumor tissue and the blood of patients with NF-1. If the investigators are able to identify circulating microRNAs in this population of pediatric patients, they will build upon this data in proposing a future study.

NCT ID: NCT01490476 Completed - Neurofibromatosis 2 Clinical Trials

Efficacy and Safety Study of RAD001 in the Growth of the Vestibular Schwannoma(s) in Neurofibromatosis 2 (NF2) Patients

AFINF2
Start date: January 2012
Phase: Phase 2
Study type: Interventional

The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients.

NCT ID: NCT01419639 Completed - Clinical trials for Neurofibromatosis Type II

Phase II Study of Everolimus (RAD001) in Children and Adults With Neurofibromatosis Type 2

Start date: October 2011
Phase: Phase 2
Study type: Interventional

This trial studies whether Everolimus is efficacious in treating neurofibromatosis 2.

NCT ID: NCT01412892 Completed - Clinical trials for Neurofibromatosis Type 1

Use of RAD001 as Monotherapy in the Treatment of Neurofibromatosis 1 Related Internal Plexiform Neurofibromas

NFitor
Start date: April 2011
Phase: Phase 2
Study type: Interventional

Background: Patients with the genetic disorder neurofibromatosis Type 1 (NF1) are at increased risk of developing tumors of the central and peripheral nervous system. These include plexiform neurofibromas. The conventional treatment of these internal plexiform neurofibromas is surgery. This surgery can be possible on a single and limited tumor. On the other hand these tumors are often surgically intractable due to their multiplicity and their infiltrating characteristics Increased activity of mammalian target of rapamycin(mTOR) protein is seen in neurofibromas. mTOR inhibitor rapamycin , or its derivatives such as everolimus may slow or stop tumor growth in patients with NF1. Objectives: Primary objectives To determine whether everolimus has an effect on the volume of surgically intractable and life-threatening internal plexiform neurofibromas in patients with neurofibromatosis 1. Secondary objectives To determine whether everolimus has an effect on the number and the volume of cutaneous neurofibromas; to determine whether everolimus modify the signaling pathways in cutaneous neurofibromas. Eligibility: - Adults with neurofibromatosis type 1 with at least one internal plexiform neurofibroma, life-threatening or causing significant morbidity through compression of organs. This or these internal plexiform neurofibroma(s) should be intractable by surgery. Design: An open-label, single arm, non-randomized, single stage phase IIa study. Baseline phase: Baseline evaluations will be performed within 2 weeks, and up to a maximum of 4 weeks for specific exams, before the first dose of study drug. Treatment phase/duration of treatment: All patients will be treated with RAD001 10 mg p.o daily dose for one year except in case of unacceptable toxicity, death, or discontinuation from the study for any other reason. Follow-up phase: All patients will have two follow-up visits scheduled at 18 and 24 months after the first dose of the study drug to follow for adverse events (AEs) and serious adverse events (SAEs) that may have occurred after discontinuation from the study and for internal plexiform neurofibromas assessment. Radiological review: All Magnetic Resonance Imaging (MRIs) obtained at baseline, during the treatment period and the follow-up period will be reviewed by the Neuroradiologist of the study.