An Open Label Registry Study of Lutetium-177 (DOTA0, TYR3) Octreotate (Lu-DOTA-TATE) Treatment in Patients with Somatostatin Receptor Positive Tumours

Launched by LONDON HEALTH SCIENCES CENTRE RESEARCH INSTITUTE OR LAWSON RESEARCH INSTITUTE OF ST. JOSEPH'S · Sep 10, 2014

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Lu-DOTA-TATE, which is a type of radiopharmaceutical used for patients with specific types of tumors known as somatostatin receptor positive tumors, particularly neuroendocrine carcinomas. The main goals of the study are to see how well this treatment can help patients live longer without their disease getting worse and to assess how it affects their quality of life. Researchers will also be monitoring any side effects from the treatment.

To be eligible for this trial, participants need to be between the ages of 14 and 90 and must have a confirmed somatostatin receptor positive tumor that can be measured. They should also be in good overall health, with certain lab results meeting specific criteria. Patients who have previously received treatment with Lu-DOTA-TATE or other related therapies may also join the study. Throughout the trial, participants will receive the treatment and be closely monitored by medical professionals to ensure their safety and track the treatment’s effectiveness. It’s important for potential participants to discuss this option with their healthcare provider to see if it’s the right fit for them.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Group A: Primary therapy subjects will be included in the study if they meet all of the following general criteria:
• • 1. Male or female ≥ 14 - 90 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
• • 2. Presence of somatostatin receptor positive tumour(s) (either histologically or Octreoscan image proven), with at least 1 tumour site reliably evaluable by CT or MRI of at least 1.5 cm (smallest dimension) with respect to RECIST criteria (the target lesion).
• • 3. Presence of somatostatin receptors on (at least) the target lesion demonstrated by uptake of OctreoScan® at least equal to liver uptake within 12 weeks of enrollment.
• • 4. Life expectancy greater than 26 weeks from enrollment.
• • 5. Serum creatinine ≤ 130 μmol/L, and a measured glomerular filtration rate (GFR) using plasma clearance of ≥50 mL/min measured within 2 weeks of enrollment.
• • 6. Haemoglobin concentration ≥ 90 g/L; white blood cell count (WBC) ≥ 3 x 109/L; platelets ≥ 100 x 109/L measured within 2 weeks of enrollment.
• • 7. Liver function tests (serum albumin, total bilirubin, alanine amniotransferase (ALT),aspartate aminotransferase (AST) and alkaline phosphatase) ≤ 3 X the limit of normal.
• • 8. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 measured within 2 weeks of enrollment.
• • 9. Provide written informed consent prior to enrollment.
• • 10. Ki 67 \< 20%, unless patients has been treated with chemotherapy and lesions are stable (Ki 67 \< 30%)
• Group B: Secondary therapy subjects will be included in the study if they meet all of the following general criteria:
• • 1. Male or female ≥ 14 - 90 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of the last menstrual period, a negative pregnancy test is required.
• • 2. Have received Lu-DOTA-TATE treatment at the London Health Sciences Centre under the Special Access Programed or other radionuclide therapy for neuroendocrine tumor.
• • 3. Provide written informed consent prior to enrollment.
• Exclusion Criteria:
• Group A: Primary therapy subjects will be excluded from the study if they meet any of the following criteria:
• • 1. Potential for surgery with curative intent. Local surgery for symptomatic relief permitted as long as target lesion unaffected.
• • 2. Surgery, radiation therapy, radioisotope therapy, change in Sandostatin LAR therapy dosage, cytotoxic chemotherapy, embolization or other investigative therapy \[interferons, mammalian target of rapamycin (mTOR) inhibitors\] within 12 weeks of enrollment. Localized external beam irradiation permitted as long as target lesion unaffected.
• • 3. Known brain metastases unless these metastases have been treated or stable (confirmed by CT) for ≥ 6 months prior to enrollment
• • 4. Uncontrolled diabetes mellitus defined as fasting glucose ≥ 3 X the upper limit of normal within 12 weeks of enrollment.
• • 5. Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence, co-existing malignancies).
• • 6. Pregnancy.
• • 7. Breast feeding.
• • 8. Prior radiation therapy to more than 25% of the bone marrow.
• Group B: Secondary therapy subjects will be excluded from the study if they meet any of the following criteria:
• • 1. Another significant medical, psychiatric or surgical condition uncontrolled by treatment, which may interfere with completion or conduct of the study (such as urinary incontinence, co-existing malignancies).
• • 2. Pregnancy.
• • 3. Breast feeding.