Status:
COMPLETED
Phase II Study of KW2871 Combined With High Dose Interferon-α2b in Patients With Metastatic Melanoma
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
University of Pittsburgh
University of Chicago
Conditions:
Metastatic Melanoma
Cutaneous Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was a Phase 2, open-label study of KW2871 (ecromeximab) in combination with high-dose interferon-α2b (HDI) in patients with metastatic melanoma. The primary objectives of this study were to asses...
Detailed Description
Eligible patients were sequentially enrolled into dose-escalating cohorts to receive KW2871 intravenously (IV) once every 2 weeks starting on Day 3 of Week 1 at the following doses: 5 mg/m\^2 in Cohor...
Eligibility Criteria
Inclusion
- Age ≥ 18 years of age.
- Histologically proven metastatic cutaneous, mucosal, or unknown primary melanoma.
- Measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST).
- Ambulatory (Eastern Cooperative Oncology Group \[ECOG\] performance status 0 or 1) or expected survival ≥ 4 months.
- Within the last 2 weeks prior to study day 1, the following laboratory parameters within the ranges specified:
- Hemoglobin: ≥ 9 g/dL
- Platelets: ≥ 100 x 10\^9/L
- Neutrophils: ≥ 1.5 x 10\^9/L
- International normalized ratio: ≤ 2.0 (≤ 3.0 if on warfarin therapy)
- Serum creatinine: ≤ 1.5 x upper limit of normal (ULN)
- Serum total bilirubin: ≤ 1.5 x ULN
- Aspartate aminotransferase/alanine aminotransferase: ≤ 2.5 x ULN
- Able and willing to give valid written informed consent.
Exclusion
- Other malignancy within 3 years prior to study entry for which the patient received active treatment, except for treated melanoma or non-melanoma skin cancer, cervical cancer, and breast carcinoma in situ.
- Mental impairment that may have compromised the ability to give informed consent and comply with the study requirements.
- Participation in any other clinical trial involving chemotherapy, radiotherapy, or other immunotherapy within 4 weeks prior to study enrollment.
- Prior exposure to anti-GD3 antibodies.
- Pregnancy or breastfeeding.
- Women of childbearing potential who refused or were unable to use effective means of contraception.
- Active autoimmune or other disorders that required systemic treatment with immunomodulatory or immunosuppressant medications (i.e., corticosteroids, cyclophosphamide, methotrexate, other biologics). Corticosteroids at substitution doses were allowed.
- Metastatic brain disease was allowed provided that appropriate treatment had been administered (surgery or irradiation) and 2-month follow-up by brain magnetic resonance imaging (MRI) showed disease control (stability or regression).
- Autoimmune-related hypothyroidism and vitiligo-like depigmentation were allowed provided the patient was medically stable with treatment (thyroid-hormone replacement or observation).
- Serious medical illness, such as cardiovascular disease (uncontrolled congestive heart failure or hypertension, active ischemic disease of the heart \[angina\], recent \[\<3 months\] myocardial infarction, severe cardiac arrhythmia), bleeding disorders, obstructive or restrictive pulmonary diseases, active systemic infections requiring antibiotics, serious intercurrent illness requiring hospitalization, inflammatory bowel disorders, or significant psychiatric disease, which in the opinion of the principal investigator would have prevented adequate informed consent or rendered study treatment unsafe or contraindicated.
- Patients with clinical suspicion of human immunodeficiency virus (HIV) or hepatitis underwent the following viral tests: patients with HIV must have had negative antibodies; patients with hepatitis B virus must have had negative antigens; patients with hepatitis C virus must have had a negative test for serum antibodies. If any of the tests were positive, patients were excluded from the study.
Key Trial Info
Start Date :
March 28 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00679289
Start Date
March 28 2008
End Date
February 3 2014
Last Update
October 12 2022
Active Locations (2)
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1
University of Chicago Hospital
Chicago, Illinois, United States, 60637
2
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213