Status:
COMPLETED
Safety and Imaging Study of GC1008 in Glioma
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Genzyme, a Sanofi Company
Conditions:
Primary Brain Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Brain tumors account for only 2% of all cancers but result in a disproportionate share of cancer morbidity and mortality. The five-year survival rates for the most common histologic subtypes, anaplast...
Detailed Description
Brain tumors account for only 2% of all cancers but result in a disproportionate share of cancer morbidity and mortality. The five-year survival rates for the most common histologic subtypes, anaplast...
Eligibility Criteria
Inclusion
- Part 1
- Inclusion Criteria
- \> 18 years
- WHO 0,1,2
- Suspicion of malignant glioma on contrast-enhanced MRI
- Able to give written informed consent
- Exclusion Criteria
- Meningeal carcinomatosis, uncontrolled seizures, or a disease that either causes or threatens neurologic compromise
- Pregnant or nursing women
- Known allergy to component of 89Zr-GC1008
- Significant medical or psychosocial problems
- Part 2
- Inclusion Criteria
- Relapsed malignant glioma
- Patient may have undergone surgery for the recurrence. Residual and measurable disease after surgery is not required. Surgery must have confirmed the recurrence. Post-operative MRI must be made within 48 hours following surgery
- For non operated patients, recurrent disease must be at least one bidimensionally measurable target lesion (contrast enhancing lesion) with one diameter of at least 2cm, based on MRI scan done within 4 weeks prior to start of treatment
- 18 years
- WHO 0,1,2
- Serum albumin ≥3.0 g/dL
- Adequate organ function including:
- Hb ≥10.0 g/dL
- ANC ≥1,500/mm3
- platelets ≥100,000/mm3
- Serum total bilirubin ≤1.5 x ULN (Patients with Gilbert's Disease may be included if their total bilirubin is ≤3.0 mg/dL)
- ALT and AST ≤2.5 x ULN.
- Estimated or measured creatinine clearance ≥60 mL/min
- PT and PTT within normal ranges
- Negative tests for hepatitis viruses B and C and HIV, unless the result is consistent with prior vaccination or prior infection with full recovery
- Enrollment \>4 weeks since major surgery, radiotherapy, chemotherapy (≥6 weeks if they were treated with a nitrosourea, mitomycin, or monoclonal antibodies), immunotherapy, or biotherapy/targeted therapies and recovered from the toxicity of prior treatment to ≤ Grade 1, exclusive of alopecia. Concurrent cancer therapy is not permitted (except for corticosteroids) (For long acting agents, a treatment free interval of 2 half lives should be considered)
- Able to give written informed consent
- Patients of child-producing potential must agree to use effective contraception while enrolled on study and receiving the experimental drug, and for at least 3 months after the last treatment
- Exclusion Criteria
- History of ascites or pleural effusions , unless successfully treated, completely resolved, and the patient has not been treated for these conditions for \>4 months
- Active thrombophlebitis, thromboembolism, hypercoagulability states, bleeding, or use of anti-coagulation therapy. Patients with a history of deep venous thrombosis may participate if successfully treated, completely resolved, and no treatment has been given for \>4 months
- Hypercalcemia: Calcium \>11.0 mg/dL (2.75 mmol/L) unresponsive or uncontrolled in response to standard therapy
- Pregnant or nursing women
- Diagnosis with another malignancy - unless following curative intent therapy, the patient has been disease free for at least 5 years and the probability of recurrence of the prior malignancy is \<5%. Patients with curatively treated early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for this study
- Organ transplant, including allogeneic bone marrow transplant
- Investigational agents used within 4 weeks prior to study enrollment (within 6 weeks for long-acting agents such as a monoclonal antibody)
- Immunosuppressive therapy including: cyclosporine A, tacrolimus, or sirolimus
- Significant or uncontrolled medical illness, such as congestive heart failure, myocardial infarction, symptomatic coronary artery disease, significant ventricular arrhythmias within the last 6 months, or significant pulmonary dysfunction. Patients with a remote history of asthma or active mild asthma may participate
- Active infection, including unexplained fever (temperature \>38.1 'C), or antibiotic therapy within 1 week prior to enrollment
- Systemic autoimmune disease
- Known allergy to component of GC1008 or 89Zr-GC1008
- Significant medical or psychosocial problems
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01472731
Start Date
December 1 2011
End Date
November 1 2012
Last Update
May 6 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ