Status:
TERMINATED
Biodistribution Study of CMD-193 in Patients With Advanced Tumours Expressing the Lewis-Y Antigen
Lead Sponsor:
Ludwig Institute for Cancer Research
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This was a Phase 1 dose-escalation study of CMD-193, a humanized monoclonal antibody linked to the toxin calicheamicin, in subjects with advanced tumors expressing the Lewis-Y antigen. The primary stu...
Detailed Description
Subjects received a single infusion of 111-In-CMD-193 on Day 1. Collection of blood for PK and whole body gamma camera imaging for assessment of biodistribution and tumor uptake were performed on Days...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Signed and dated Institutional Review Board (IRB)-approved informed consent before any protocol-specific screening procedures were performed.
- Histologically confirmed malignant solid tumor that had progressed following standard therapy, or for which no standard effective treatment was available.
- Tumor expression of Lewis-Y antigen (≥20% tumor cells positive for Lewis-Y by immunohistochemistry assay).
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST), including the presence of at least one measurable lesion at least 2 cm in size suitable for 18F-FDG PET imaging.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 18 weeks.
- Age ≥18 years.
- Recovery to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) ≤ Grade 1 toxicity from any significant effects of prior surgery, radiation therapy, and cancer therapy (except alopecia).
- Renal test: serum creatinine ≤ 1.5 x upper limit of normal (ULN).
- Hepatic tests: alanine aminotransferase (ALT) levels ≤2.5 x ULN and total bilirubin ≤1.5 x ULN.
- Pancreatic tests: amylase ≤1.5 x ULN and lipase ≤ 1.5 x ULN.
- Bone marrow tests: absolute neutrophil count (ANC) of ≥1500 mm\^3 (≥1.5 x 10\^9/L) and platelet count of ≥ 150,000/mm\^3 (≥150 x 10\^9/L).
- For women of childbearing potential, a negative serum pregnancy test result no longer than 48 hours before the first dose of CMD-193. A woman of childbearing potential was one who was biologically capable of becoming pregnant. This included women who were using contraceptives or whose sexual partners were either sterile or using contraceptives.
- All subjects who were not surgically sterile or postmenopausal must have agreed and committed to the use of a reliable method of birth control for the duration of the study and for 28 days after the last dose of CMD-193.
- Willingness of female subjects to refrain from breastfeeding infants during the study or within 28 days after the last dose of CMD-193.
- Exclusion Criteria
- Chemotherapy, radiation therapy, other cancer therapy, or investigational agents within 21 days of the first dose of CMD-193 (42 days if the previous chemotherapy included nitrosoureas or mitomycin C).
- Symptomatic or clinically active central nervous system (CNS) metastases. Subjects who had prior treatment with radiotherapy or surgical resection for CNS metastases were permitted if CNS metastases had remained stable and not required any treatment for at least 3 months prior to the first dose of CMD-193.
- Significant prior allergic reaction to recombinant human or murine proteins.
- History of cirrhosis, current or chronic hepatitis B or C infections, or other significant active liver disease.
- Unstable or serious concurrent medical conditions. Examples included, but were not limited to, bleeding gastric ulcers, gastrointestinal bleeding, hepatitis, significant disorders of the immune system (eg, systemic lupus erythematosus), pancreatitis, congestive heart failure, serious active infections (e.g. requiring antibiotics or antiviral agents), unstable angina, recent myocardial infarction (within 6 months of screening), ongoing maintenance therapy for life-threatening ventricular arrhythmia, or uncontrolled major seizure disorder.
- Other malignancy within 3 years prior to entry into the study, except for treated non-melanoma skin cancer and cervical carcinoma in situ.
- Any other condition that, in the Investigator's judgment, would have substantially increased the risk associated with the subject's participation in this study.
Exclusion
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00293215
Start Date
February 1 2006
End Date
May 1 2007
Last Update
October 10 2022
Active Locations (2)
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1
Cancer Care Services, Dept. of Medical Oncology, Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4209
2
Ludwig Institute Tumor Targeting Program, Austin Health
Heidelberg (Melbourne), Victoria, Australia, 3084