A Phase II Multi-Dose Study of SGN-30 (anti-CD30 mAb) in Patients with Refractory or Recurrent Hodgkin’s Disease or Anaplastic Large Cell Lymphoma -

Conditions: Refractory or Recurrent Hodgkin’s Disease or Anaplastic Large Cell Lymphoma MedDRA version 6.0PT=Hodgkin's Disease NOS recurrent=10020256PT=Hodgkin's Disease NOS refractory=10020257PT=Anaplastic large cell lymphoma T- and null-cell types recurrent=1002229PT=Anaplastic large cell lymphoma T- and null-cell types refractory=1002230
MedDRA version: 6.0Level: PTClassification code 10020256

Registration Number: EUCTR2004-000607-17-BE

Lead Sponsor: Seattle Genetics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

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. 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 transplantation.
7.Patients who have undergone stem cell transplantation must have received at least one therapy post-transplantation. Patients who have not had stem cell transplantation must be considered ineligible or refuse treatment by stem cell transplantation. Treatments associated with bone marrow transplant, such as mobilization and conditioning, will be considered as one regimen.
8.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.
9.Patients must have an ECOG performance status of less than or equal to 2 and a life expectancy > three months.
10.Patients must be at least 18 years of age.
11.Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
12.Females of childbearing potential must have a negative beta-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.
13.Patients must give written informed consent. A copy of the signed informed consent form will be retained in the patient’s chart.
14.Required baseline laboratory data:
- Absolute neutrophil count greater than or equal to 1,250/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

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

1.Patients with primary cutaneous ALCL
2.Patients who have been treated previously with any anti-CD30 antibody
3.Patients who have received any mAb unless a recent serum testing reveals no antibody titer and no evidence of human anti-murine antibodies (HAMA) or human anti-chimeric antibodies (HACA) in the peripheral circulation
4.Patients receiving any investigational biological agent within eight weeks of enrollment or any other investigational agent within four weeks of enrollment
5.Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation
6.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
7.Patients with known active viral, bacterial, or systemic fungal infection; patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
8.Patients with symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias
9.Patients with symptomatic brain metastases requiring treatment
10.Patients who are pregnant or breastfeeding
11.Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment
12.Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent