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Trial record 2 of 881 for:    "Reticulum Cell Sarcoma"

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

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ClinicalTrials.gov Identifier: NCT00099255
Recruitment Status : Completed
First Posted : December 10, 2004
Last Update Posted : December 18, 2014
Sponsor:
Information provided by:
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE December 10, 2004
First Posted Date  ICMJE December 10, 2004
Last Update Posted Date December 18, 2014
Study Start Date  ICMJE September 2004
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2006)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • To determine the objective response rate in patients who receive SGN-30 at 2 different dosages
  • To determine the duration of response in patients with pcALCL treated with SGN-30
  • To investigate the toxicity profile of SGN-30
Change History Complete list of historical versions of study NCT00099255 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2006)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • To provide preliminary estimates of disease-free and overall survival rates in pcALCL patients treated with SGN-30
  • To determine the immunogenicity of SGN-30 in patients with pcALCL
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Large Cell Lymphoma
Intervention  ICMJE Drug: SGN-30
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00099255
Other Study ID Numbers  ICMJE SG030-0004
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Seattle Genetics, Inc.
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP