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

Large Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00099255
• Other study ID #: SG030-0004
• Status: Completed
• Phase: Phase 2
• First received: December 10, 2004
• Last updated: December 17, 2014
• Start date: September 2004
• Est. completion date: February 2007

Study information

• Verified date: December 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00118079

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Large Cell Lymphoma
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin
• Lymphoma, Primary Cutaneous Anaplastic Large Cell
• Lymphomatoid Papulosis
• Mycosis Fungoides

Intervention

Drug:
• SGN-30

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the objective response rate in patients with pcALCL, T-MF, and LyP
Primary	To determine the duration of response in patients treated with SGN-30
Primary	To investigate the toxicity profile of SGN-30
Secondary	To provide preliminary estimates of disease-free and overall survival rates in pcALCL and T-MF patients treated with SGN-30
Secondary	To determine the immunogenicity of SGN-30

External Links

•   Link
•   Anaplastic Large Cell Lymphoma resource site