Refractory or Recurrent Hodgkin’s Disease or Anaplastic Large Cell Lymphoma MedDRA version 6.0 PT=Hodgkin's Disease NOS recurrent=10020256 PT=Hodgkin's Disease NOS refractory=10020257 PT=Anaplastic large cell lymphoma T- and null-cell types recurrent=1002229 PT=Anaplastic large cell lymphoma T- and null-cell types refractory=1002230 MedDRA version: 6.0 Level: PT Classification code 10020256
Conditions
Interventions
Product Name: --
Product Code: SGN-30
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: --
CAS Number: --
Current Sponsor code: SGN-30
Other descriptive name: chimeric AC-10
Concentratio
Sponsors
Seattle Genetics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must have refractory or recurrent HD or refractory or recurrent ALCL. 2. Patients must have histologically confirmed CD30+ HD or ALCL. ALK status must be known and tissue must be available for central review. Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy tissue of relapsed disease. 3. Patients must have bidimensional measurable disease on physical examination or radiologic evaluation. 4. Patients must have failed systemic chemotherapy either as initial therapy for advanced disease or as salvage therapy after initial radiotherapy for early stage disease. 5. Patients may have received no more than four treatments (radiation, chemotherapy, and/or biologics) prior to enrollment. 6. Patients may have received no more than one stem cell transplanta (SCT). Patients who have not had a SCT must be considered ineligible or refuse treatment by SCT when it is available as a treatment option. Treatments associated with bone marrow transplant, such as mobilization and conditioning, will be considered as one regimen. 7. Patients must have completed radiotherapy and/or chemotherapy at least four weeks prior to enrollment. Any prior treatment with nitrogen mustard agents, melphalan, or BCNU must have been completed at least six weeks prior to enrollment. 8. Patients must have an ECOG performance status of = 2 (see Appendix B) and a life expectancy = three months. 9. Patients must be at least 18 years of age. 10. Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution. 11. Females of childbearing potential must have a negative ß-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. 12. Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient’s chart. 13. Required baseline laboratory data (Support with GF and/or transfusions is allowed): - Absolute neutrophil count = 1,000/mm3 - Platelet count = 50,000/mm3 - Serum bilirubin = 1.5 times ULN - Serum creatinine = 1.5 times ULN - Urea BUN = 1.5 times ULN Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with primary cutaneous ALCL, unless they have systemic involvement. 2. Patients who have been treated previously with any anti-CD30 antibody 3. Patients receiving any investigational biological agent within eight weeks of enrollment or any other investigational agent within four weeks of enrollment 4. Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation 5. 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. 6. Patients with known systemic viral, bacterial, or systemic fungal infection; patients who are known to be HIV, Hepatitis B antigen positive, or Hepatitis C positive. 7. Patients with symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias, if this would, in the opinion of the investigator interfere with assessment of the safety or efficacy of the study drug. 8. Patients with symptomatic brain metastases requiring treatment 9. Patients who are pregnant or breastfeeding 10. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment 11. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of this phase II study are as follows: - To determine the objective response rate of SGN-30 in two study groups, patients with HD, treated with 6 or 12 mg/kg and patients with ALCL treated with 6 or 12 mg/kg - To determine the duration of response in patients with HD and in patients with ALCL - To investigate the toxicity profile of SGN-30 at a dose of 6 or 12 mg/kg for ALCL or doses of 6 or 12 mg/kg for HD ;Secondary Objective: The secondary objectives of this phase II study are as follows: - To provide preliminary estimates of disease-free and overall survival in patients with HD and in patients with ALCL - To determine the immunogenicity of SGN-30 at a dose of 6 or 12 mg/kg in patients with ALCL and to determine the immunogenicity of SGN-30 at a dose of 6 or 12 mg/kg in patients with Hodgkin's disease. ;Primary end point(s): For Hodgkin’s Disease patients, objective tumor response (Partial Remission, Complete Remission, Stable Disease or Progressive Disease) will be determined based on the Cotswolds criteria (J Clin Oncol 1989; 7(11):1630-6). For ALCL patients, objective tumor response (Partial Remission, Complete Remission, Stable Disease or Progressive Disease) will be determined based on the Cheson criteria (J Clin Oncol 1999; 17(4):1244-53). Initial responses will be determined four weeks after the final SGN-30 infusion. Time to response (PR+CR), duration of response, progression-free survival, and overall survival will be summarized for evaluable patients. | — |
Countries
Denmark, Italy, Sweden
Outcome results
None listed