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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00099255
Recruitment Status : Completed
First Posted : December 10, 2004
Last Update Posted : December 18, 2014
Information provided by:
Seagen Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Large Cell Lymphoma Drug: SGN-30 Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multi-Dose Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma, Large Cell Transformation of Mycosis Fungoides, and Lymphomatoid Papulosis
Study Start Date : September 2004
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Primary Outcome Measures :
  1. To determine the objective response rate in patients with pcALCL, T-MF, and LyP
  2. To determine the duration of response in patients treated with SGN-30
  3. To investigate the toxicity profile of SGN-30

Secondary Outcome Measures :
  1. To provide preliminary estimates of disease-free and overall survival rates in pcALCL and T-MF patients treated with SGN-30
  2. To determine the immunogenicity of SGN-30

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • 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

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 identifier (NCT number): NCT00099255

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90095
Stanford University
Stanford, California, United States, 94305
United States, Connecticut
New Haven, Connecticut, United States, 06520
United States, Illinois
Northwestern Universtiy
Chicago, Illinois, United States, 60611
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21827
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Memorial Sloan-Kettering
New York, New York, United States, 10021
United States, Ohio
Cleveland University
Cleveland, Ohio, United States, 44106
United States, Oregon
Kaiser Permanente - Oncology Research
Portland, Oregon, United States, 97227
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Seagen Inc.
Additional Information:
Publications of Results:
Layout table for additonal information Identifier: NCT00099255    
Obsolete Identifiers: NCT00118079
Other Study ID Numbers: SG030-0004
First Posted: December 10, 2004    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 2014
Keywords provided by Seagen Inc.:
Primary Cutaneous Anaplastic Large Cell Lymphoma
Large Cell Transformation of Mycosis Fungoides
Lymphomatoid Papulosis
Additional relevant MeSH terms:
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Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphomatoid Papulosis
Lymphoma, Primary Cutaneous Anaplastic Large Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell