search
Back to results

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

Primary Purpose

Hodgkin Disease, Lymphoma, Large-Cell, Sarcoma, Kaposi

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SGN-30 (monoclonal antibody)
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hodgkin Disease

Eligibility Criteria

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

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

Sites / Locations

  • University of Alabama, Birmingham
  • USC Norris Cancer Center
  • University of Miami
  • Dana Farber Cancer Institute
  • Siteman Cancer Center
  • University of Nebraska
  • Cornell Medical College, New York Presbyterian
  • University of Rochester
  • MD Anderson Cancer Center
  • University of Washington

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 13, 2003
Last Updated
October 7, 2011
Sponsor
Seagen Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00051597
Brief Title
A Safety/Efficacy Study of SGN-30 (Antibody) in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies
Official Title
A Phase I/II Multi-Dose Study of SGN-30 in Patients With Refractory or Recurrent CD30+ Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seagen Inc.

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Disease, Lymphoma, Large-Cell, Sarcoma, Kaposi, Lymphoma, T-Cell, Cutaneous, Lymphoma, B-Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SGN-30 (monoclonal antibody)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy P Sing, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama, Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
USC Norris Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Siteman Cancer Center
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
Country
United States
Facility Name
Cornell Medical College, New York Presbyterian
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
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
18079362
Citation
Bartlett NL, Younes A, Carabasi MH, Forero A, Rosenblatt JD, Leonard JP, Bernstein SH, Bociek RG, Lorenz JM, Hart BW, Barton J. A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. Blood. 2008 Feb 15;111(4):1848-54. doi: 10.1182/blood-2007-07-099317. Epub 2007 Dec 13.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs