Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET. (PUTNET)

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: NCT04276597
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Excel Diagnostics and Nuclear Oncology Center

Tracking Information
First Submitted Date  ICMJE February 14, 2020
First Posted Date  ICMJE February 19, 2020
Last Update Posted Date July 12, 2021
Estimated Study Start Date  ICMJE July 30, 2021
Estimated Primary Completion Date July 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2020)
Assessment of the overall response rate [ Time Frame: 12 monts ]
determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2020)
Progression Free Survival (rPFS) in subjects receiving 4 cycles of therapy Monitoring of the changes in quality of life (QOL) through assessment of ECOG performance status and a QOL subject questionnaire. [ Time Frame: 12 months ]
determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.
Official Title  ICMJE A Phase II, Non-Randomized, Open-Label, Single-center, Physician Sponsored Study to Determine the Safety and Effectiveness of Lu-177 DOTATOC in Adult Subjects With Somatostatin Receptor Expressing Pulmonary, Pheochromocytoma, paragangliomUnknown Primary, and Thymus Neuroendocrine Tumors (PUTNET) or Any Other Non-.GEP-NET.
Brief Summary

Determine the safety and effectiveness of Lu-177 DOTATOC in adult subjects with somatostatin receptor-expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymus neuroendocrine tumors or any other non-.GEP-NET.

The treatment regimen will consist of 4 doses of 200 (±10%) mCi 177Lu-DOTATOC administered at 8+/- 1-week intervals.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Neuroendocrine Neoplasm
  • Pheochromocytoma
  • Paraganglioma
  • Thymus Carcinoid
  • Unknown Primary Tumors
  • Neuroendocrine Tumors
  • Neuroendocrine Skin Carcinoma
  • Neuroendocrine Breast Tumor
  • Neuroendocrine Carcinoma Metastatic
  • Neuroendocrine Neoplasm of Ovary
Intervention  ICMJE Drug: 177Lu-DOTATOC
177Lu labeled somatostatin receptors targeting ligand
Study Arms  ICMJE Experimental: Lu177 DOTATOC treatment
4 doses of 200mCi 177Lu- DOTATOC PRRT
Intervention: Drug: 177Lu-DOTATOC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 17, 2020)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 30, 2024
Estimated Primary Completion Date July 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Signed informed consent.
  • Subjects of either sex, aged ≥18 years.
  • ECOG status 0-2.
  • Life-expectancy of at least 12 weeks.
  • Histologically/cytologically confirmed diagnosis of SSTR (+) neuroendocrine tumors of the lung, Pheochromocytoma, Paraganglioma, thymus, and unknown primary, unresectable or metastatic.
  • Measurable disease per RECIST 1.1, on CT/MRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter (lymph nodes along short axis >15 mm).
  • Appropriate diagnostic imaging studies, at the discretion of the P.I. including but not limited to CT, MRI , 18F-FDG PET/CT, NAF PET/CT bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day.
  • Somatostatin receptor positive (SSTR+) disease, as evidenced by available FDA, commercially of IND approved SSTR imaging (SRI), within 4 weeks prior to the first cycle
  • Recent blood test results (within 2weeks pre-dose) as follows:
  • Sufficient bone marrow capacity as defined by WBC ≥2,500/µl and WBC≥2,000/mm3 for subsequent cycles; platelets ≥ 100,000 (100 * 103/mm3) for the first treatment and ≥75,000 for the subsequent therapies, Hgb ≥8.9 g/dl for the first treatment and 8.0 g/dl for the subsequent therapies, ANC ≥1500/mm3 for the first treatment and ≥1000/ mm3; for the subsequent therapies.
  • ALT, AST values ≤3 times ULN
  • Bilirubin: ≤3 times ULN
  • Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dl
  • Negative pregnancy test in women capable of child-bearing within 48 hours of IMP administration.
  • Serum albumin > 3.0g/L (<3 g/L may be acceptable at the discretion of investigator, if PT, PTT, and INR are within normal range)
  • All available FDA-approved therapies for which the subject is eligible have been exhausted (with the exception of PRRT), unless available therapies are refused by the subject (with the exception of somatostatin analogue, octreotide, and somatuline).

Exclusion Criteria:

  • Known hypersensitivity to any of the excipients of Lu-177 DOTATOC.
  • Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 1 day) prior to treatment.
  • Subjects with unusual hematological parameters, including an increased MCV (>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be sought for adequate further work-up
  • Any subject who is taking concomitant medications that decrease renal function (such as aminoglycoside antibiotics).
  • Female subjects who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 67 days (more than 10 half-lives of 177Lu after the last treatment, or male subjects who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 67 days after the last treatment.
  • Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
  • Indication for surgical lesion removal with curative potential
  • Planned (for the period of study participation): chemotherapy, immunotherapy, radiation therapy (unless regional for pain relief) chemo-embolization, bland embolization, radio-embolization, treatment with cyclosporine-A.
  • Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrolment
  • Completion of: (1) cytotoxic chemotherapy for less than 6 weeks; (2) a biological agent for less than 5 half-lives; and (3) radiation therapy (except regional for pain relief) for less than 6 weeks prior to study enrolment,
  • Uncontrolled congestive heart failure; subjects suspected of having this condition need to show ejection fraction of > 35% as determined by MUGA scan.
  • Glomerular Filtration Rate (GFR) < 35 mL/min
  • Subjects with prior peptide receptor radionuclide therapy (PPRT).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Susan Cork 713-781-6200 ext 3203 scork@exceldiagnostics.com
Contact: Rouzbeh Esfandiari, MD 713-781-6200 ext 3279 resfandiari@exceldiagnostics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04276597
Other Study ID Numbers  ICMJE 143631
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Excel Diagnostics and Nuclear Oncology Center
Study Sponsor  ICMJE Excel Diagnostics and Nuclear Oncology Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ebrahim Delpassand, MD Excel Diagnostics and Nuclear Oncology Center
Study Director: Rodolfo Nunez, MD Excel Diagnostics and Nuclear Oncology Center
Study Director: Afshin Shafie, MD Excel Diagnostics and Nuclear Oncology Center
Study Director: Ayman Gaber, MD Excel Diagnostics and Nuclear Oncology Center
PRS Account Excel Diagnostics and Nuclear Oncology Center
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP