A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies

This study has been completed.
Sponsor:
Information provided by:
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT00051597
First received: January 13, 2003
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to evaluate a multi-dose regimen of SGN-30, a novel chimeric monoclonal antibody (mAb), in patients with refractory or recurrent CD30+ hematologic malignancies.

This is a single-arm, open-label phase I/II study designed to define the toxicity profile, pharmacokinetic (PK) profile, and anti-tumor activity of a multi-dose regimen of SGN-30 in patients with refractory or recurrent CD30+ hematologic malignancies. The phase I study will be a modified dose escalation of SGN-30. Based on preclinical pharmacology and toxicokinetics (TK) and the first use in human single-dose phase I study, SGN-30 will be administered on a weekly schedule. An initial dose of 2 mg/kg will escalate until the maximum tolerated dose (MTD) has been reached or until a weekly dose of 12 mg/kg is achieved.


Condition Intervention Phase
Hodgkin Disease
Lymphoma, Large-Cell
Sarcoma, Kaposi
Lymphoma, T-Cell, Cutaneous
Lymphoma, B-Cell
Drug: SGN-30 (monoclonal antibody)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Multi-Dose Study of SGN-30 in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Estimated Enrollment: 70
Study Completion Date: August 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

Histologically confirmed CD30+ hematologic malignancy. Immunohistochemistry or flow cytometry may be performed on either original diagnostic biopsy material or biopsy of relapsed disease.

Patients must have at least one of the following:

  • Patients with HD must have failed systemic chemotherapy either as initial therapy for advanced stage disease or as salvage therapy after initial radiotherapy (XRT) for early stage disease and be ineligible for, or refuse treatment by stem cell transplantation
  • Patients with other CD30+ malignancies must be beyond 1st remission or refractory to front line chemotherapy
  • Patients with refractory or chemo-resistant multiple myeloma (MM), as defined by a failure to respond (<50% reduction in M-protein level), or disease progression less than 2 months after receiving at least two conventional chemotherapy regimens
  • Patients with MM in the Plateau Phase of their disease may be included in the study. Plateau phase will be defined as persistent (more than 6 weeks) M-protein in the serum or urine despite a significant initial reduction (>50%) in response to previous therapy. These patients should have received at least two of the conventional chemotherapy regimens listed above prior to enrollment in this study.
  • Patients with relapsed MM as defined by disease progression more than 2 months after initial therapy and subsequent failure to respond (<50% reduction or progression in M-protein levels) to ONE of the above listed regimens or other salvage regimens (high dose cyclophosphamide, topotecan).

Patients must have at least one of the following:

  • Bidimensional or unidimensional measurable disease on physical examination or radiologic evaluation
  • Circulating tumor cells in peripheral blood
  • Evidence of bone marrow disease to any degree in patients with HD
  • >10% tumor cells in bone marrow in patients with other CD30+ malignancies
  • Minimum of 4 weeks from last therapy (including radiotherapy or chemotherapy); a minimum of 6 weeks from last treatment with nitrogen mustard agents, melphalan or BCNU
  • ECOG performance status ≤ 2 (Appendix B) with a life expectancy > 3 months

EXCLUSION CRITERIA:

  • A diagnosis of Cutaneous T-Cell Lymphoma (CTCL) or non-secretory MM
  • Symptomatic cardiac disease including ventricular dysfunction, coronary artery disease or arrhythmias
  • More than one primary malignancy with the exception of non-melanoma skin cancer or cervical carcinoma in situ (CIN) on a biopsy or squamous intraepithelial lesion (SIL) on PAP smear
  • Active viral, bacterial, or systemic fungal infection including known HIV positivity
  • Symptomatic brain metastases requiring treatment
  • Concurrent therapy with other anti-neoplastic agents, corticosteroids, or experimental agents
  • Any serious underlying medical condition which would impair the ability of the patient to receive or tolerate the planned treatment including prior allergic reactions to recombinant human or murine proteins
  • Receipt of any therapeutic mAbs within 6 months unless a recent serum testing reveals no antibody titer and no evidence of anti-chimeric or anti-murine antibody in the peripheral circulation
  • Female patients who are pregnant or breastfeeding
  • Dementia or altered mental status that would prohibit the understanding and rendering of informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00051597

Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
United States, California
USC Norris Cancer Center
Los Angeles, California, United States, 90033
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Missouri
Siteman Cancer Center
St. Louis, Missouri, United States, 63110
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198
United States, New York
Cornell Medical College, New York Presbyterian
New York, New York, United States, 10021
University of Rochester
Rochester, New York, United States, 14642
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Amy P Sing, MD Seattle Genetics, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00051597     History of Changes
Other Study ID Numbers: SG030-0002
Study First Received: January 13, 2003
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Sarcoma, Kaposi
Lymphoma, B-Cell
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Hematologic Neoplasms
Sarcoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Neoplasms, Connective and Soft Tissue
Neoplasms, Vascular Tissue
Lymphoma, Non-Hodgkin
Neoplasms by Site
Hematologic Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 15, 2014