Status:
COMPLETED
A Safety Study of SGN-40 in Patients With Non-Hodgkin's Lymphoma
Lead Sponsor:
Seagen Inc.
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Non-Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is an open-label, multi-dose, Phase I, dose escalation study to define the safety profile and preliminary anti-tumor activity of SGN-40 in patients with refractory or recurrent non-Hodgkin B-cell...
Detailed Description
A minimum of 3 patients will be entered into each dose-level cohort for 5 weeks. A dose-escalation schema will be employed in cohorts. The initial dose starts at 1 mg/kg on Day 1 and 4 followed by 2mg...
Eligibility Criteria
Inclusion
- Patients must have a histological diagnosis of B cell non-Hodgkin's lymphoma, including diffuse large B-cell, mantle cell, follicular, small lymphocytic, and marginal zone lymphoma by the World Health Organization criteria.
- Patients must have an archived paraffin or fresh tumor specimen available for immunohistologic evaluation of CD40, CD20, \& CD79a.
- Patients must have relapsed lymphoma and must have failed frontline chemotherapy.
- Patients who have not received autologous stem cell transplant must have refused or be ineligible for it.
- Patients must have completed radiotherapy, chemotherapy, and/or treatment with investigational anti-cancer agents 4 weeks prior to registration. Patients must have completed any monoclonal antibody treatment, including rituximab, 6 months prior to registration.
- Patients must have completed autologous bone marrow transplant 4 months prior to registration.
- Patient must have at least one site of measurable disease defined by unidimensional lesion ≥ 2 cm by conventional CT scan.
- Patients must have an ECOG performance status ≤ 2 and a life expectancy \> 3 months.
- Patients must have the following required baseline laboratory data:
- Platelet count ≥ 75,000/mm3,
- Hemoglobin ≥ 9.0 g/dL,
- Absolute neutrophil count ≥ 1,250/mm3,
- ALT/AST ≤ 2.5 times ULN,
- Total bilirubin ≤ 1.5 times ULN,
- Creatinine \< 1.5 mg/dL,
- Females of childbearing potential must have a negative serum β-hCG pregnancy test result within 3 days prior to the first dose of SGN-40 and must agree to use an effective contraceptive method during the course of the study and for 6 months following the last dose of study drug.
- If a deep venous thrombosis or other vascular even has required medical or surgical intervention in the past year, patients must either be on stable dose of anticoagulant therapy for at least 3 weeks or have completed anticoagulant therapy at least 3 months prior to registration with radiographic confirmation that thrombosis is resolved.
- 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.
Exclusion
- Patients with history or clinical evidence of leptomeningeal or central nervous system (CNS) lymphoma.
- Patients with a documented history within 6 months of registration of a cerebral vascular event, myocardial infarction, deep venous thrombosis or other vascular event that has required medical or surgical intervention. Patients must have completed anticoagulant therapy at least 3 months prior to registration. Prophylactic anticoagulant therapy for indwelling catheters is acceptable.
- Patients who have received an allogeneic stem cell transplant.
- Patients who have had major surgery within 4 weeks prior to registration.
- Patients with a known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
- Patients with a history of another primary malignancy that has not been in remission for at least 5 years (non-melanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear are exempt from the five year limit).
- Patients with any active systemic viral, bacterial, or fungal infection within four weeks prior to registration.
- Patients with known positivity for HIV, hepatitis B or hepatitis C infection.
- Patients with a history of significant chronic or recurrent infections requiring treatment.
- Patients with a history of migraines or severe headaches requiring medical therapy within 12 months of enrollment.
- Patients on systemic steroids who have not been on a stable daily dose (not exceeding 10 mg prednisone or equivalent) during 4 weeks prior to the first dose of SGN 40.
- 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 the understanding and/or rendering of informed consent.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00103779
Start Date
December 1 2004
End Date
March 1 2007
Last Update
December 18 2014
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Stanford University
Stanford, California, United States, 94305
3
University of Miami
Miami, Florida, United States, 33136
4
Cornell University
New York, New York, United States, 10029