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

Anaplastic Large-Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00079755
• Other study ID #: SG030-0003
• Status: Completed
• Phase: Phase 2
• First received: March 12, 2004
• Last updated: December 17, 2014
• Start date: February 2004
• Est. completion date: December 2006

Study information

• Verified date: December 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00107133

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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.

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anaplastic Large-Cell Lymphoma
• Lymphoma
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• SGN-30 (anti-CD30 mAb)

Locations

Country	Name	City	State
United States	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland
United States	University of Alabama, Birmingham	Birmingham	Alabama
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Northwestern University	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Texas MD Anderson Cancer Center	Houston	Texas
United States	University of Califorinia at Los Angeles	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Cornell University	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	Kaiser Permanente	Portland	Oregon
United States	Oregon Health Science University	Portland	Oregon
United States	University of Rochester	Rochester	New York
United States	University of Washington	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Georgetown University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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 dis — View Citation

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