Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma

Completed · Phase 2

Conditions studied: Large Cell Lymphoma

In brief

This multi-center, phase II study will be conducted to define the toxicity profile and antitumor activity of SGN-30 in patients with pcALCL and other closely related lymphoproliferative disorders.

Key facts

Study ID

NCT00099255

Run by

Seagen Inc.

People needed

40

Starts

2004-09-01

Expected to finish

2007-02-01

Last updated by the study team

2014-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have a definite diagnosis.
• Patients must be histologically confirmed CD30 positive within 3 months of enrollment
• Patients with pcALCL must have target lesions present for at least 1 month without spontaneous regression
• pcALCL patients must have failed treatment with local radiation therapy, or failed systemic therapy of a single agent
• Patients must be considered an eligible candidate for systemic therapy as determined by the investigator
• All patients must have a three week wash-out from previous treatments, unless in the opinion of the investigator it is not in the best interest of the patient, at which point the individual case must be discussed with the medical monitor prior to enrollment.
• Patients must have an ECOG performance status of < 2 (Appendix B) and a life expectancy > six months.
• Patients must be at least 18 years of age.
• Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
• Females of childbearing potential must have a negative HCG pregnancy test result within three days of enrollment. All patients must agree to use an effective contraceptive method during the course of the study.
• Patients must give written informed consent.
• Required baseline laboratory data: Absolute neutrophil count greater than or equal to to 1,000/mm3, Platelet count greater than or equal to 75,000/mm3, Serum bilirubin less than or equal to 1.5 times ULN, Serum creatinine less than or equal to 1.5 times ULN, BUN less than or equal to 1.5 times ULN, SGOT less than or equal to 2.5 ULN, SGPT less than or equal to 2.5 ULN
• Criteria for Exclusion
• Patients with Sezary syndrome, or any type of lymphoproliferative disease other than pcALCL, T-MF or LyP
• Patients with systemic ALCL or extracutaneous involvement of cutaneous ALCL
• Patients with known active systemic viral, bacterial, or fungal infection
• Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive
• Patients who have been treated previously with any anti-CD30 antibody
• Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation
• Patients with a history of other malignancies during the past five years with the exception of adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ
• Patients with symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias
• Patients who are pregnant or breastfeeding
• Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment
• Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of California at Los Angeles — Los Angeles, California, United States
• Stanford University — Stanford, California, United States
• Yale — New Haven, Connecticut, United States
• Northwestern Universtiy — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Johns Hopkins — Baltimore, Maryland, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Memorial Sloan-Kettering — New York, New York, United States
• Cleveland University — Cleveland, Ohio, United States
• Kaiser Permanente - Oncology Research — Portland, Oregon, United States
• Vanderbilt University — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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