EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

Back to results

Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

EPO906 (epothilone B)

About this trial

This is an interventional treatment trial for Central Nervous System Neoplasms focused on measuring CNS and head and neck cancers, Histologically confirmed CNS malignancy head and neck, there is on standard therapy or, have failed standard therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Thomas Jefferson University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort 1 Brain Tumors

Cohort 2 Head and Neck Tumors

Arm Description

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.

Outcomes

Primary Outcome Measures

Maximum tolerated dose (MTD) of EPO906

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00328458

First Posted

May 19, 2006

Last Updated

July 13, 2018

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00328458

Brief Title

EPO906 Plus Radiation Therapy for the Treatment of Cancer Patients

Official Title

A Phase I, Open-label, Dose-escalation, Safety Study of the Combination of EPO906 and Radiation Therapy for the Treatment of Patients With Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

February 2004 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 1 Brain Tumors

Arm Type

Experimental

Arm Description

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.

Arm Title

Cohort 2 Head and Neck Tumors

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

EPO906 (epothilone B)

Primary Outcome Measure Information:

Title

Maximum tolerated dose (MTD) of EPO906

Time Frame

Baseline to 7 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline to 7 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adam Dicker, MD, PhD

Organizational Affiliation

Thomas Jefferson University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thomas Jefferson University Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Central Nervous System Neoplasms, Head and Neck Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial