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

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ClinicalTrials.gov Identifier: NCT01432483
Recruitment Status : No longer available
First Posted : September 13, 2011
Last Update Posted : January 26, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Cancer Drug: Denileukin diftitox (ONTAK)

Detailed Description:
The Access Program will be provided as long as appropriate according to the judgment of the provider. If Denileukin diftitox (ONTAK) becomes commercially available without restriction, then the access program will be discontinued.

Study Design

Study Type : Expanded Access
Official Title: Access Program With Denileukin Diftitox for the Treatment of Patients Currently Receiving Treatment With Commercially Available (Ontak)
Interventions

Intervention Details:
    Drug: Denileukin diftitox (ONTAK)
    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.
    Other Name: ONTAK
Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients are not eligible for the Access Program with denileukin diftitox if they:

• Are not currently on denileukin diftitox therapy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432483


Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Gary Palmer, MD Eisai Inc.
More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01432483     History of Changes
Other Study ID Numbers: E7272-A001-401
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: January 2015

Keywords provided by Eisai Inc.:
Cancer
ONTAK
Denileukin diftitox
persistent or recurrent disease
requiring continued delivery of essential cancer therapy

Additional relevant MeSH terms:
Denileukin diftitox
Interleukin-2
Antineoplastic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs