Clinical trial NCT00099255: Study of SGN-30 (Anti-CD30 mAb) in Patients With Primary Cutaneous Anaplastic Large Cell Lymphoma
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Large Cell Lymphoma
Keywords: Keyword?
Primary Cutaneous Anaplastic Large Cell Lymphoma
Large Cell Transformation of Mycosis Fungoides
Lymphomatoid Papulosis
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
First posted: 2004-12-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: To determine the objective response rate in patients with pcALCL, T-MF, and LyP
measure: To determine the duration of response in patients treated with SGN-30
measure: To investigate the toxicity profile of SGN-30
Secondary outcomes:
measure: To provide preliminary estimates of disease-free and overall survival rates in pcALCL and T-MF patients treated with SGN-30
measure: To determine the immunogenicity of SGN-30
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale
state: Connecticut
city: Chicago
country: United States
facility: Northwestern Universtiy
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan-Kettering
state: New York
city: Cleveland
country: United States
facility: Cleveland University
state: Ohio
city: Portland
country: United States
facility: Kaiser Permanente - Oncology Research
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
References:
citation: 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.