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

Primary Purpose

Anaplastic Large-Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SGN-30 (anti-CD30 mAb)
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Large-Cell Lymphoma focused on measuring Anaplastic Large-Cell Lymphoma, Lymphoma, antigens, CD30, Monoclonal Antibody

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Alabama, Birmingham
  • University of Califorinia at Los Angeles
  • Georgetown University
  • University of Miami
  • Northwestern University
  • University of Maryland Greenebaum Cancer Center
  • Dana Farber Cancer Institute
  • University of Minnesota
  • Washington University School of Medicine
  • University of Nebraska
  • Roswell Park Cancer Institute
  • Cornell University
  • University of Rochester
  • Duke University Medical Center
  • Kaiser Permanente
  • Oregon Health Science University
  • University of Texas MD Anderson Cancer Center
  • University of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 12, 2004
Last Updated
December 17, 2014
Sponsor
Seagen Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00079755
Brief Title
Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent Anaplastic Large Cell Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seagen Inc.

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Large-Cell Lymphoma
Keywords
Anaplastic Large-Cell Lymphoma, Lymphoma, antigens, CD30, Monoclonal Antibody

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SGN-30 (anti-CD30 mAb)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
University of Califorinia at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
91342
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-7680
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Kaiser Permanente
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12097283
Citation
Wahl AF, Klussman K, Thompson JD, Chen JH, Francisco LV, Risdon G, Chace DF, Siegall CB, Francisco JA. The anti-CD30 monoclonal antibody SGN-30 promotes growth arrest and DNA fragmentation in vitro and affects antitumor activity in models of Hodgkin's disease. Cancer Res. 2002 Jul 1;62(13):3736-42.
Results Reference
result
PubMed Identifier
19466965
Citation
Forero-Torres A, Leonard JP, Younes A, Rosenblatt JD, Brice P, Bartlett NL, Bosly A, Pinter-Brown L, Kennedy D, Sievers EL, Gopal AK. A Phase II study of SGN-30 (anti-CD30 mAb) in Hodgkin lymphoma or systemic anaplastic large cell lymphoma. Br J Haematol. 2009 Jul;146(2):171-9. doi: 10.1111/j.1365-2141.2009.07740.x. Epub 2009 May 19.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/19466965
Description
Related Info

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

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