Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent Anaplastic Large Cell Lymphoma

Sponsor

Seagen Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00079755

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To investigate safety and antitumor activity of SGN-30 in patients with Hodgkin's Disease and anaplastic large cell lymphoma (ALCL).

As of March 22, 2005, interim analysis of the Hodgkin's Disease (HD) arm has been completed per the statistical plan in the protocol. SG030-0003 is now closed to further recruitment of HD patients.

Condition or Disease	Intervention/Treatment	Phase
Anaplastic Large-Cell Lymphoma	Drug: SGN-30 (anti-CD30 mAb)	Phase 2

Detailed Description

SGN-30 is the chimeric form of a novel murine monoclonal antibody (mAb), AC-10, that has specificity for CD30. The CD30 antigen has a very low expression on normal cells, but is expressed on malignant cells in Hodgkins disease and anaplastic large cell lymphoma.

This study is designed to define the toxicity profile and antitumor activity of SGN-30 in patients with refractory or recurrent Hodgkin's disease and with refractory or recurrent anaplastic large cell lymphoma. Patients will receive 6 weekly intravenous (IV) infusions of SGN-30 followed by a 4 week observation period.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2004

Actual Primary Completion Date :

Dec 1, 2006

Actual Study Completion Date :

Dec 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients must have refractory or recurrent HD or refractory or recurrent ALCL.
Patients must have histologically confirmed CD30+ HD or ALCL.
Patients must have bidimensional measurable disease on physical examination or radiologic evaluation.
Patients must have failed systemic chemotherapy either as initial therapy for advanced disease or as salvage therapy after initial radiotherapy for early stage disease.
Patients may have received no more than four treatments (radiation, chemotherapy, and/or biologics) prior to enrollment.
Patients may have received no more than one stem cell transplantation.
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.
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.
Patients must have an ECOG performance status of ≤ 2 and a life expectancy > three 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 β-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. A copy of the signed informed consent form will be retained in the patient's chart.
Patients must meet baseline lab data requirements.

Exclusion Criteria:

Patients with primary cutaneous ALCL
Patients who have been treated previously with any anti-CD30 antibody
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
Patients receiving any investigational biological agent within eight weeks of enrollment or any other investigational agent within four weeks of enrollment
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 known active viral, bacterial, or systemic fungal infection; patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
Patients with symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias
Patients with symptomatic brain metastases requiring treatment
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama, Birmingham	Birmingham	Alabama	United States	35294-3300
2	University of Califorinia at Los Angeles	Los Angeles	California	United States	91342
3	Georgetown University	Washington	District of Columbia	United States	20007
4	University of Miami	Miami	Florida	United States	33136
5	Northwestern University	Chicago	Illinois	United States	60611
6	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland	United States	21201
7	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
8	University of Minnesota	Minneapolis	Minnesota	United States	55455
9	Washington University School of Medicine	St. Louis	Missouri	United States	63110
10	University of Nebraska	Omaha	Nebraska	United States	68198-7680
11	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
12	Cornell University	New York	New York	United States	10021
13	University of Rochester	Rochester	New York	United States	14642
14	Duke University Medical Center	Durham	North Carolina	United States	27710
15	Kaiser Permanente	Portland	Oregon	United States	97227
16	Oregon Health Science University	Portland	Oregon	United States	97239
17	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
18	University of Washington	Seattle	Washington	United States	98109