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April 2012: Trials in Progress

Published: Tuesday, Apr 17, 2012
The Trials in Progress section is intended to stimulate discussion about ongoing clinical trials and to promote collaboration across the oncology community. Each month, OBTN will present summaries of ongoing research in a broad range of cancer types.

Brain Cancer

Donepezil for neurocognitive symptoms in irradiated brain tumor patients

This phase III study will compare the effects of the reversible acetylcholinesterase inhibitor donepezil versus placebo for improving neurocognitive symptom cluster in patients who have undergone partial- or whole-brain irradiation for brain tumors. Donepezil is approved for the treatment of mild to moderate Alzheimer’s-type dementia. Subjects will be randomized to donepezil or placebo once or twice daily for up to 24 weeks in the absence of unacceptable toxicity. The primary outcome measures are fatigue, subjective confusion, and cognitive performance at 24 weeks. The researchers will also compare the effects of these regimens on mood and quality of life.

Sponsor: Wake Forest University

ClinicalTrials.gov Identifier: NCT00369785


Sarcoma

TH-302 with doxorubicin or solo doxorubicin in soft-tissue sarcoma

This phase III study will determine whether the hypoxiaactivated prodrug TH-302 in combination with doxorubicin is a safe and effective treatment for patients with locally advanced unresectable or metastatic soft-tissue sarcoma who have not received prior chemotherapy. Eligible patients are required to have a pathologically confirmed diagnosis of soft-tissue sarcoma of the following histopathologic types: synovial sarcoma, high-grade fibrosarcoma, undifferentiated sarcoma or sarcoma not otherwise specified, liposarcoma, leiomyosarcoma (excluding gastrointestinal stromal tumor), angiosarcoma (excluding Kaposi’s sarcoma), malignant peripheral nerve sheath tumor, pleomorphic rhabdomyosarcoma, myxofibrosarcoma, epithelioid sarcoma, or undifferentiated pleomorphic sarcoma/malignant fibrous histiocytoma (including pleomorphic, giant cell, myxoid, and inflammatory forms). Study participants will be randomized to treatment with TH-302 with doxorubicin or doxorubicin alone. The primary outcome measure is overall survival. The study aims to recruit about 450 patients, with a completion date in early 2015.

Sponsor: Threshold Pharmaceuticals

ClinicalTrials.gov Identifier: NCT01440088


Head and Neck Cancer

Efficacy of Reolysin with paclitaxel and carboplatin in platinum-refractory head and neck cancer

This phase III study is comparing intravenous administration of Reolysin (Reovirus Type 3 Dearing) combined with paclitaxel and carboplatin or chemotherapy treattreatment alone in patients with metastatic or recurrent squamous cell carcinoma of the head and neck who have progressed on or after prior platinum-based chemotherapy. Reolysin is an unmodified oncolytic reovirus that selectively replicates in Ras-activated cancer cells while not causing any significant human illness in its wild form. The primary outcome measure is overall survival. Patients will be evaluated clinically after each treatment course and radiologically every 6 weeks during and after treatment. The safety of the paclitaxel and carboplatin with intravenous blinded placebo or intravenous blinded Reolysin will also be assessed. The study aims to recruit 280 patients.

Sponsor: Oncolytics Biotech

ClinicalTrials.gov Identifier: NCT01166542


Management of chronic dry mouth in radiation-treated head and neck cancer

This phase II/III study is comparing acupuncture-like transcutaneous electrical nerve stimulation (ALTENS) versus pilocarpine for treating xerostomia in patients undergoing radiation therapy for head and neck cancer in a cooperative group setting. Subjects are randomized to undergo either electrode placement at several acupuncture points followed by ALTENS to each of these points twice weekly for 20 minutes or oral pilocarpine 3 times daily. Treatment is continued for up to 12 weeks in the absence of disease progression or unacceptable toxicity. The primary outcome measures include successful delivery of ALTENS using the Codetron unit (phase II) and overall xerostomia burden at 9 months after randomization as measured by an established xerostomia-related quality-of-life scale (phase III). Overall, 45 patients will be accrued to the phase II portion and 144 patients to the phase III portion of the study.

Sponsor: Radiation Therapy Oncology Group

ClinicalTrials.gov Identifier: NCT00656513


Hematologic Cancer

Lenalidomide and dexamethasone with or without bortezomib in multiple myeloma


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