Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma
NCT ID: NCT00099255
Last Updated: 2014-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2004-09-30
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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SGN-30
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Seagen Inc.
INDUSTRY
Locations
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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
Countries
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References
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Duvic M, Reddy SA, Pinter-Brown L, Korman NJ, Zic J, Kennedy DA, Lorenz J, Sievers EL, Kim YH. A phase II study of SGN-30 in cutaneous anaplastic large cell lymphoma and related lymphoproliferative disorders. Clin Cancer Res. 2009 Oct 1;15(19):6217-24. doi: 10.1158/1078-0432.CCR-09-0162. Epub 2009 Sep 29.
Related Links
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Related Info
Other Identifiers
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SG030-0004
Identifier Type: -
Identifier Source: org_study_id
NCT00118079
Identifier Type: -
Identifier Source: nct_alias