Dosimetry-Guided, Peptide Receptor Radiotherapy (PRRT) With 90Y-DOTA- tyr3-Octreotide (90Y-DOTATOC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03273712|
Recruitment Status : Recruiting
First Posted : September 6, 2017
Last Update Posted : June 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors Meningioma Neuroblastoma Medulloblastoma||Radiation: 90Y-DOTA tyr3-Octreotide Diagnostic Test: 68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan Drug: Amino Acids||Phase 2|
This is a Phase 2 peptide receptor radionuclide therapy trial of 90Y-DOTATOC in patients with somatostatin receptor positive tumors. The somatostatin receptor targeting of the therapeutic will be checked with 68Ga-DOTATOC PET-CT imaging prior to therapy. Treatment consists of 3 cycles, 6-8 weeks apart. Cycle 1 dose is fixed with Cycles 2 and 3 doses to be determined by dosimetry-based calculation of renal doses from previous cycles not to exceed 23 Gy for the total renal dose.
The goals of this project are to
- Demonstrate the safety and efficacy of dosimetry-guided peptide receptor radiotherapy using 90Y-DOTA-tyr3-Octreotide in patients with neuroendocrine and other somatostatin receptor expressing tumors.
- Monitor all adverse events associated with peptide receptor radiotherapy using 90Y-DOTATOC.
- Establish 68Ga-DOTA-tyr3-Octreotide (68Ga-DOTATOC) or 68Ga-DOTATATE PET/CT as an accurate technique for diagnosis, staging, treatment targeting, and monitoring response to 90Y-DOTATOC therapy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II, Dosimetry Guided, Peptide Receptor Radiotherapy (PRRT) Using 90Y-DOTA tyr3-Octreotide (90Y-DOTATOC) in Children and Adults With Neuroendocrine and Other Somatostatin Receptor Positive Tumors|
|Actual Study Start Date :||September 29, 2017|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Patients will receive 3 doses of 90YDOTATOC followed by 90Y-DOTATOC PET scans, with 6 -8 weeks between doses. They will be followed for 6-9 months after the last treatment dose. CT or MRI scans will be given at the 3 month and 6-9 month followups plus a 68Ga-DOTATOC or DOTATATE PET scan at the 6-9 month followup. The exact dose of 90YDOTATOC therapy for each patient will be determined by dosimetry.
Radiation: 90Y-DOTA tyr3-Octreotide
90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
Other Name: 90Y-DOTATOC
Diagnostic Test: 68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan
68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
Drug: Amino Acids
This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
Other Name: Lysine and Arginine
- Treatment efficacy as assessed by change and defined as complete response, partial response or stable disease (CR+PR+SD) [ Time Frame: Lesions will be quantified and compared between pre-therapy and through follow-up visits: 1) occuring 3-4 months after treatment and 2) occurring 6-9 months after treatment ]Tumor response defined by RECIST1.1 criteria applied on up to five target lesions (primary tumor if not surgically removed, up to two liver lesions, up to two nodal metastases, metastatic lesion in other organs, such as ovary, breast) that will be quantified and compared between pre-therapy and 3-9 months post-therapy high-resolution, contrast-enhanced CTs. 90Y DOTATOC will be deemed worthy of further study if its associated response rate is ≥ 0.60, and clinically uninteresting if its rate is ≤ 0.40.
- Renal, hematologic and clinical toxicities [ Time Frame: Initiation of treatment through last followup visit (6-9 months) after last treatment ]Adverse events will be recorded and reported in tabular form by type and grade. If four or more subjects experience renal toxicity ≥ Grade 4, the radiopharmaceutical will be declared too toxic and the trial will be stopped. If any other irreversible Grade 4 toxicity is observed in four or more subjects, the treatment will be declared too toxic and will be stopped. Adverse events will be graded according to the most recent CTE guidelines.
- Accuracy of 68Ga-DOTATOC PET/CT in Participants [ Time Frame: 9 months ]Analyze accuracy of 68Ga-DOTATOC PET/CT to monitor response to PRRT after Cycle 1 and to evaluate overall response to PRRT. Change in metabolic activity (Standardized Uptake Value or SUV) in target lesions will be utilized to determine response to therapy using 1) SUVmax and 2) change in metabolic tumor burden and compared to RECIST criteria.
- Response to therapy of lesions identified by 68Ga-DOTATOC PET/CT [ Time Frame: 9 months ]For those subjects who participated in NCT01869725, determine response to therapy of lesions identified by 68Ga-DOTATOC PET/CT but not on Octreoscan as a confirmatory measure of true positives. The number, size, and location of discordant lesions between 68Ga-DOTATOC PET and Octreoscan will have been tabulated. This analysis will be updated using the results of post-therapy.
- Standard Uptake Value (SUV) on initial 68Ga-DOTATOC PET and SSTR2 expression [ Time Frame: 9 months ]Determine if Standard Uptake Value (SUV) on initial 68Ga-DOTATOC PET imaging correlates with SSTR2 expression as measured by quantitative messenger RNA (qPCR) or immunohistochemistry (IHC) on the diagnostic biopsy specimen. Compare SUVmax between primary tumor, liver lesions, and extra-hepatic lesions with expression levels of sst2 using qRT-PCR and/or receptor IHC from fresh frozen or paraffin-embedded samples where available.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03273712
|Contact: M. Sue O'Dorisio, MD, PhDemail@example.com|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: M. Sue O'Dorisio, MD, PhD 319-356-7873 firstname.lastname@example.org|
|Principal Investigator:||M. Sue O'Dorisio, MD, PhD||University of Iowa|