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Glioblastoma clinical trials

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NCT ID: NCT01956734 Completed - Clinical trials for Glioblastoma Multiforme

Virus DNX2401 and Temozolomide in Recurrent Glioblastoma

D24GBM
Start date: September 2013
Phase: Phase 1
Study type: Interventional

Phase I trial, unicentric, uncontrolled. Intratumoral injection or intramural (into the resected tumor cavity) of DNX2401 into brain tissue will be followed by up to two 28 - day cycles of oral temozolomide (TMZ) in schedule of 7 days on/7 days off to evaluate safety of the combination. Completion of two full cycles of TMZ will be dependent upon tolerance and toxicity. The rationale in using the virus with chemotherapy begins with the lessons learned in many clinical trials in glioblastoma (GBM) about both the great difficulty of treating this disease with monotherapy and the limitations of the therapeutic virus. The best clinical results in recent years have been achieved with combinations of multiple therapeutics efforts, including, maximum resection and chemotherapy, immunotherapy and targeted therapies. There are very strong preclinical data about the synergy of DNX-2401 and TMZ proposed in our trial design. The dose-dense schemes of TMZ like the one we will use, have been developed with the aim to saturate o6-methylguanine-DNA-methyltransferase (MGMT). The published results to date have shown reasonable toxicity albeit with modest efficacy' these schemes are now in phase III trials. In addition, autophagy triggered by TMZ could help viral replication in the tumor cells 11. The last argument in favor of this virus + TMZ combination is the proved efficacy in killing GBM tumor stem cells. In vitro and animals models have shown this combination is much more effective that any of the treatments alone against GBM stem cells and the tumors derived from them.

NCT ID: NCT01934361 Completed - Clinical trials for Recurrent Glioblastoma Multiforme

Phase Ib/II Study of Buparlisib Plus Carboplatin or Lomustine in Patients With Recurrent Glioblastoma Multiforme

Start date: February 28, 2014
Phase: Phase 1
Study type: Interventional

This is a multi-center, phase Ib/ II study (two parts) with patients that had recurrent glioblastoma multiforme. The first part (phase Ib) was to investigate the maximum tolerated dose/Recommended phase ll dose (MTD/RP2D) of once daily buparlisib in combination with every-three-week carboplatin or buparlisib once daily in combination with every-six-week lomustine (CCNU) using a Bayesian model. Once MTD/ RP2D is established in either of the 2 arms, the corresponding phase II portion of the study was to start. Phase II was to assess the treatment effect of buparlisib in combination with carboplatin in terms of Progression Free Survival (PFS) and was to compare the treatment effect of buparlisib with lomustine versus lomustine plus placebo in terms of PFS. A preliminary assessment for both combinations (buparlisib plus carboplatin or lomustine) demonstrated that there was not enough antitumor activity compared to historical data with single agent carboplatin or lomustine. Based on the overall safety profile, and preliminary anti-tumor activity observed in this study, Novartis decided that no additional patients would be enrolled into this study. As a consequence, the Phase II part of the study was not conducted.

NCT ID: NCT01931098 Completed - Glioblastoma Clinical Trials

Oral Pazopanib Plus Oral Topotecan Metronomic Antiangiogenic Therapy for Recurrent Glioblastoma Multiforme (A) Without Prior Bevacizumab Exposure and (B) After Failing Prior Bevacizumab

Start date: December 10, 2015
Phase: Phase 2
Study type: Interventional

Background: Glioblastoma is the most common and most aggressive type of malignant brain tumor. The drug pazopanib is used to treat people with a type of kidney cancer. Topotecan is used to treat lung cancer. Both topotecan and pazopanib have individually been used to treat patients with glioblastoma and some anti-tumor activity has been found. Researchers want to see if these two drugs together may be able to help people with glioblastoma. Objectives: To learn if pazopanib with topotecan can help control glioblastoma. Also, to study the safety of this drug combination. Eligibility: Adults at least 18 years old whose glioblastoma has returned after treatment. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Brain computed tomography (CT) or magnetic resonance imaging (MRI) For these, participants lay in a machine that takes pictures. Chest CT scan or x-ray Heart electrocardiogram (EKG) A questionnaire about quality of life Participants will be assigned to a study group. Participants will take the study drugs for 28-day cycles for up to 1 year. They will take capsules of topotecan by mouth once every day. They will take tablets of pazopanib by mouth once every day. Participants will write in a diary the times they take the study drugs. Participants will have several study visits during each cycle. These may include Blood pressure measurement Blood and urine tests EKG Physical exam and/or neurological exam Brain MRI or CT scan to check the status of the disease A symptom questionnaire At the end of treatment, participants will have a physical exam. They may have blood drawn. Participants will have follow-up calls once every 3 months to check.

NCT ID: NCT01929720 Completed - Depression Clinical Trials

Cognitive-Behavioral Intervention for Worry, Uncertainty, and Insomnia for Cancer Survivors

FOCUS
Start date: August 2011
Phase: N/A
Study type: Interventional

This randomized clinical trial studies a cognitive-behavioral intervention to treat worry, uncertainty, and insomnia in cancer survivors. Counseling may reduce anxiety and insomnia as well as improve the well-being and quality of life of cancer survivors. This study also explores the neuro-immunologic correlates of anxiety and insomnia.

NCT ID: NCT01922076 Completed - Glioblastoma Clinical Trials

Adavosertib and Local Radiation Therapy in Treating Children With Newly Diagnosed Diffuse Intrinsic Pontine Gliomas

Start date: September 3, 2013
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and the best dose of adavosertib when given together with local radiation therapy in treating children with newly diagnosed diffuse intrinsic pontine gliomas. Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays, gamma rays, neutrons, protons, or other sources to kill tumor cells and shrink tumors. Giving adavosertib with local radiation therapy may work better than local radiation therapy alone in treating diffuse intrinsic pontine gliomas.

NCT ID: NCT01920191 Completed - CNS Tumor, Adult Clinical Trials

Phase I/II Trial of IMA950 Multi-peptide Vaccine Plus Poly-ICLC in Glioblastoma

Start date: August 2013
Phase: Phase 1/Phase 2
Study type: Interventional

RATIONALE : IMA 950 is multi tumour-associated peptides (TUMAPs) vaccine, these peptides have been identified on primary glioblastoma multiforme (GBM) cells. Poly-ICLC is a potent vaccine adjuvant with broad innate and adaptive immune enhancing effects. IMA 950 and Poly-ICLC will be administered to patients alongside standard primary therapy for glioblastoma. This includes the alkylating drug temozolomide (TMZ). Effective vaccine-induced immune responses associated with prolonged survival have been observed in glioblastoma patients during TMZ adjuvant therapy, suggesting a possible synergistic effect. A second component of glioblastoma standard treatment is external beam irradiation of the tumor site post-surgery. As a side effect, potentially beneficial tumor-infiltrating immune cells may also be killed by radiation. However, the combination of radiation with immunotherapy has been suggested to be favorable both in pre-clinical models.

NCT ID: NCT01907165 Completed - Glioblastoma Clinical Trials

Disulfiram in Treating Patients With Glioblastoma Multiforme After Radiation Therapy With Temozolomide

Start date: October 10, 2013
Phase: Early Phase 1
Study type: Interventional

This clinical trial studies disulfiram in treating patients with glioblastoma multiforme (GBM) who have completed radiation therapy with temozolomide. Disulfiram may block some of the enzymes needed for tumor cell growth and improve clinical outcome in GBM patients.

NCT ID: NCT01905228 Completed - Glioblastoma Clinical Trials

A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm

Start date: July 2013
Phase: Phase 1
Study type: Interventional

This is an open-label, multi-center, sequential groups, dose-escalation study of CBL0137 administered intravenously in participants with metastatic or unresectable advanced solid malignancies.

NCT ID: NCT01904123 Completed - Metastatic Melanoma Clinical Trials

STAT3 Inhibitor WP1066 in Treating Patients With Recurrent Malignant Glioma or Progressive Metastatic Melanoma in the Brain

Start date: July 13, 2018
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of STAT3 inhibitor WP1066 in treating patients with malignant glioma that has come back or melanoma that has spread to the brain and is growing, spreading, or getting worse. STAT3 inhibitor WP1066 may stop the growth of tumor cells and modulate the immune system.

NCT ID: NCT01894061 Completed - Adult Glioblastoma Clinical Trials

NovoTTF-100A With Bevacizumab (Avastin) in Patients With Recurrent Glioblastoma

Start date: June 12, 2013
Phase: Phase 2
Study type: Interventional

NovoTTF-100A is a device and Bevacizumab is a study drug that have both been approved by the FDA (Food and Drug Administration) for use as monotherapy in treating glioblastoma multiforme. The NovoTTF-l00A is a portable battery operated device which produces TTFields within the human body using surface electrodes (transducer arrays). Intermediate frequency electric fields (TTFields) stunt the growth of tumor cells. The purpose of this study is to determine the efficacy of the combination of Bevacizumab and NovoTTF-100A in Bevacizumab naive (meaning have never received bevacizumab before) patients with recurrent glioblastoma (GBM) as measured by 6-month progression free survival.