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

This study has been completed.
Sponsor:
Information provided by:
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00099255
First received: December 10, 2004
Last updated: June 7, 2013
Last verified: October 2011
  Purpose

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 Intervention Phase
Large Cell Lymphoma
Drug: SGN-30
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

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

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

Estimated Enrollment: 40
Study Start Date: September 2004
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099255

Locations
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
Yale
New Haven, Connecticut, United States, 06520
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Northwestern Universtiy
Chicago, Illinois, United States, 60611
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
Seattle Genetics, Inc.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00099255     History of Changes
Obsolete Identifiers: NCT00118079
Other Study ID Numbers: SG030-0004
Study First Received: December 10, 2004
Last Updated: June 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Seattle Genetics, Inc.:
Keyword?
Primary Cutaneous Anaplastic Large Cell Lymphoma
Large Cell Transformation of Mycosis Fungoides
Lymphomatoid Papulosis

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Mycosis Fungoides
Lymphoma, Large-Cell, Anaplastic
Lymphomatoid Papulosis
Lymphoma, Primary Cutaneous Anaplastic Large Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell

ClinicalTrials.gov processed this record on July 28, 2014