Ontak (Denileukin Diftitox) in Patients With Systemic Mastocytosis (SM)

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

1. To assess the response rate of ONTAK in Systemic Mastocytosis (SM) patients.

Secondary Objectives:

1. To assess the safety of ONTAK in SM patients.

2. To evaluate the time to progression and duration of response following treatment with ONTAK.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Denileukin diftitox; Interleukin-2

Criteria

Inclusion Criteria:

• Patients with SM, including mast cell leukemia (MCL).

• ECOG Performance Status (PS) 0-3

• Adequate renal function (indicated by serum creatininehepatic function (indicated by ALT3 * upper limit of normal; and albumin >/= 2.8 g/dL).

• Provide written informed consent.

• Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study drug, and must agree to use an effective means of contraception following the pregnancy test, throughout the study and for at least three weeks after their last treatment on protocol.

Exclusion Criteria:

• History of hypersensitivity to diphtheria toxin.

• Active cardiovascular disease as defined by New York Heart Association (NYHA) Class III-IV categorization.

• Serious intercurrent medical illnesses or active infections requiring parenteral antibiotics that would interfere with the ability of the patient to carry out the treatment program.

• Concurrent malignancy (other than resected basal or squamous cell skin cancers or in-situ cervical cancer). Unless, patient has SM-associated clonal hematologic disease that does not require therapy, as judged by treating physician and approved by principal investigator.

• Female patients who are pregnant or breastfeeding.

• No chemotherapy, radiotherapy, immunotherapy, hormonal anticancer therapy, or experimental medications (including approved drugs tested in an investigational setting) may be administered while a patient is a participant in this protocol.