Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)

NCT01432483 | Unknown

• 1 other identifier: E7272-A001-401
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to provide continued therapy with Denileukin diftitox (ONTAK) to patients who are currently on therapy and who have no other suitable treatment options, where therapy is requested by their physician.

Conditions

Cancer

Keywords

Cancer; ONTAK; Denileukin diftitox; persistent or recurrent disease; requiring continued delivery of essential cancer therapy

Interventions

Denileukin diftitox (ONTAK) DRUG

Given at a dose of 9 or 18mcg/kg/day by intravenous infusion over 30 to 60 minutes for 5 consecutive days every 21 days for 8 cycles.

Also known as: ONTAK

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• To receive denileukin diftitox (ONTAK) under this protocol, the patient's physician must request this therapy for the specific patient. Patients may continue treatment with denileukin diftitox if they:
• Are currently on therapy with denileukin diftitox and require ongoing therapy to maintain control of their disease.
• Are willing and able to comply with all aspects of the Access Protocol
• Provide written informed consent to participate

You may not qualify if:

• Patients are not eligible for the Access Program with denileukin diftitox if they:
• Are not currently on denileukin diftitox therapy

Sponsors & Collaborators

• Eisai Inc.: lead

MeSH Terms

Conditions

Neoplasms; Recurrence

Interventions

denileukin diftitox

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gary Palmer, MD

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 13, 2011
• Last Updated: January 26, 2015

Record last verified: 2015-01