Central Nervous System Neoplasms, Head and Neck Neoplasms
Conditions
Keywords
CNS and head and neck cancers, Histologically confirmed CNS malignancy head and neck, there is on standard therapy or, have failed standard therapy
Brief summary
The purpose of this study is to determine the safety of the drug EPO906 that could shrink tumors when used with radiation therapy in cancer patients.
Detailed description
* To determine the maximum tolerated dose (MTD) of EPO906 administered in combination with radiation therapy and establish a recommend phase II dose. * To evaluate the safety and toxicity profile of EPO906 when administered concurrently with radiotherapy in three disease cohorts. * To evaluate tumor response.
Interventions
DRUGEPO906 (epothilone B)
Sponsors
Novartis Pharmaceuticals
Sidney Kimmel Cancer Center at Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Requires a minimum of 3 weeks of radiation therapy * Solid tumors with advanced or recurrent disease for which there is no standard therapy or tumors have failed standard therapy * World Health Organization (WHO) performance status equal to or less than 2 * Life expectancy equal to or greater than 3 months
Exclusion criteria
* Any peripheral neuropathy * Unresolved diarrhea greater than grade 1 * Patients who received any other investigational compound within the past 28 days * Severe cardiac insufficiency * Patients on Coumadin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) of EPO906 | Baseline to 7 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy | Baseline to 7 weeks |
Countries
United States
Outcome results
None listed