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

Seagen

Status and phase

Completed

Phase 2

Conditions

Large Cell Lymphoma

Treatments

Drug: SGN-30

Study type

Interventional

Funder types

Industry

Identifiers

NCT00099255

SG030-0004

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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