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 -

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. 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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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