EAP 177Lu-DOTA0-Tyr3-Octreotate for Inoperable, SSR+, NETs, Progressive Under SSA Tx
NCT ID: NCT02705313
Last Updated: 2018-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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APPROVED_FOR_MARKETING
EXPANDED_ACCESS
Brief Summary
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Detailed Description
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Clinical studies, including NETTER-1 for which the primary analysis has been conducted, showed clinical evidence of safety and effectiveness to support the expanded access use without any unreasonable potential risks for the patients in the context of the disease to be treated.
In July 2016, the first patient was treated under an Expanded Access Program (EAP) for inoperable, progressive, somatostatin receptor positive, midgut carcinoid tumors.
Compassionate use programs in Europe include pulmonary NETs. In the US, there were many centers with patients with NETs who did not meet the inclusion criteria for the original EAP. In May 2017, Advanced Accelerator Applications inquired with the FDA if amending the inclusion criteria of the original protocol to include all NETs would be permissible.
In June 2017, Advanced Accelerator Applications was able to submit a revision to the original Expanded Access Program's protocol for 177Lu-DOTA0-Tyr3-Octreotate to include neuroendocrine tumors arising from sites other than midgut.
The locations listed below that are participating in the EAP may have received IRB approval for either the original protocol or the new protocol or both. Please, inquire with the Facility Contact as to which protocol is active at their site.
Conditions
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Interventions
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177Lu-DOTA0-Tyr3-Octreotate
The treatment regimen consists of 4 administrations of 7.4 GBq (200 mCi) at the date and time of infusion. The recommended interval between two infusions is 8 weeks, which could be extended up to 16 weeks in case of dose modifying toxicity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ki67 index ≤ 20%
* Patients progressive under SSA (any dose) at the time of enrollment
* Target lesions over-expressing somatostatin receptors according to an appropriate imaging method (e.g. 111In-pentetreotide (Octreoscan) imaging or 68Ga-DOTA0-Tyr3-Octreotate (or 68Ga-edotreotide) imaging)
Exclusion Criteria
* Hb concentration \<5.0 mmol/L (\<8.0 g/dL); WBC \<2x109/L (2000/mm3); platelets \<75x109/L (75x103/mm3).
* Total bilirubin \>3 x ULN.
* Serum albumin \<3.0 g/dL unless prothrombin time is within the normal range.
* Pregnancy or lactation.
* For female patients of childbearing potential (defined as \< 2 years after last menstruation and not surgically sterile) and male patients, who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel).
* Any surgery, radioembolization, chemoembolization, chemotherapy and radiofrequency ablation within 12 weeks prior to enrollment.
* Interferons, Everolimus (mTOR-inhibitors) or other systemic therapies within 4 weeks prior to enrollment.
* Known brain metastases, unless these metastases have been treated and stabilized.
* Uncontrolled congestive heart failure (NYHA II, III, IV).
* Uncontrolled diabetes mellitus as defined by a fasting blood glucose \>2 ULN.
* Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of 177Lu-DOTA0-Tyr3-Octreotate, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least 4 weeks before the administration of 177Lu-DOTA0-Tyr3-Octreotate, unless the tumor uptake on target lesions is at least as high as normal liver uptake.
* Patients with any other significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may pose a risk to the patient safety
* Prior external beam radiation therapy to more than 25% of the bone marrow.
* Current spontaneous urinary incontinence making impossible the safe administration of the radioactive IMP.
* Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.
* Patients who have not provided a signed informed consent form to accept this treatment.
18 Years
ALL
No
Sponsors
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Advanced Accelerator Applications
INDUSTRY
Responsible Party
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Locations
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Banner M.D. Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
City of Hope (City of Hope Medical Center, City of Hope National Medical Center)
Duarte, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, San Francisco
San Francisco, California, United States
Kaiser Permanente, Santa Clara Homestead
Santa Clara, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora, Colorado, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Cancer Treatment Center of America - Southeastern Regional Medical Center
Newnan, Georgia, United States
Northwestern Medicine
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
The University of Iowa Hospitals & Clinics (UIHC) including the Carver College of Medicine
Iowa City, Iowa, United States
Ochsner Medical Center
Kenner, Louisiana, United States
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Kansas City Research Institute
Kansas City, Missouri, United States
Washington University School of Medicine Siteman Cancer Center
St Louis, Missouri, United States
CHI Health West Omaha Imaging Center
Omaha, Nebraska, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Stony Brook Cancer Center
Stony Brook, New York, United States
Montefiore Einstein Center for Cancer Care
The Bronx, New York, United States
Duke University Hospital
Durham, North Carolina, United States
The Ohio State University James Cancer Center
Columbus, Ohio, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh, Medical Center
Pittsburgh, Pennsylvania, United States
Bon Secours Medical Group/ Saint Francis Hospital Cancer Center
Greenville, South Carolina, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States
Carilion Clinic
Roanoke, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
University of Washington, Department of Radiology, Division of Nuclear Medicine
Seattle, Washington, United States
Countries
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Other Identifiers
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AAA-177Lu-03
Identifier Type: -
Identifier Source: org_study_id
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