EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

NCT00328458 | Completed Phase 1 DMC

• 3 other identifiers: 03C.2752003-33JT 1035
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Neoplasms; Head and Neck Neoplasms

Keywords

CNS and head and neck cancers; Histologically confirmed CNS malignancy head and neck; there is on standard therapy or; have failed standard therapy

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) of EPO906

  Baseline to 7 weeks

Secondary Outcomes (1)

• Number of participants that successful complete 7 weekly cycles of EPO906 concurrently with radiotherapy

  Baseline to 7 weeks

Study Arms (2)

Cohort 1 Brain Tumors

EXPERIMENTAL

The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort.

Drug: EPO906 (epothilone B)

Cohort 2 Head and Neck Tumors

EXPERIMENTAL

The investigational drug - EPO906 will be administered as an intravenous infusion over five to ten minutes on weeks 1, 3 and 6, for the duration of radiation therapy up to a maximum of 7 weeks. Duration of therapy will be determined by disease cohort.

Drug: EPO906 (epothilone B)

Interventions

EPO906 (epothilone B) DRUG

Cohort 1 Brain Tumors; Cohort 2 Head and Neck Tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer Center

MeSH Terms

Conditions

Central Nervous System Neoplasms; Head and Neck Neoplasms

Interventions

epothilone B

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Adam Dicker, MD, PhD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2006
• First Posted: May 22, 2006
• Study Start: February 1, 2004
• Primary Completion: May 1, 2008
• Study Completion: July 1, 2009
• Last Updated: May 2, 2025

Record last verified: 2025-05

Locations

US (1)