RECRUITING

Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma

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Conditions

PheochromocytomaParagangliomaNeuroendocrine TumorsNeuroendocrine NeoplasmsHypertensionCatecholamineFamilial SyndromesSomatostatin ReceptorsIonizing Radiation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: Pheochromocytoma and paraganglioma are rare tumors. They usually form inside and near the adrenal gland or in the neck region. Not all these tumors can be removed with surgery, and there are no good treatments if the disease has spread. Researchers think a new drug may be able to help. Objective: To learn the safety and tolerability of Lu-177-DOTATATE. Also, to see if it improves the length of time it takes for the cancer to return. Eligibility: Adults who have an inoperable tumor of the study cancer that can be detected with Ga-68-DOTATATE PET/CT imaging Design: Participants will be screened with a medical history, physical exam, and blood tests. Eligible participants will be admitted to the NIH Clinical Center. Participants will get the study drug in an intravenous infusion. They will get 4 doses, given about 8 weeks apart. Between 4 and 24 hours after each study drug dose, participants will have scans taken. They will lie on their back on a scanner table. Participants will have vital signs taken. They will give blood and urine samples. During the study, participants will have other scans taken. Some scans will use a radioactive tracer. Participants will complete quality of life questionnaires. Participants will be contacted by phone 1-3 days after they leave the Clinical Center. They will then be followed every 3 to 6 months for 3 years or until their disease gets worse.

Official Title

Lu-177-DOTATATE (Lutathera) in Therapy of Inoperable Pheochromocytoma/ Paraganglioma

Quick Facts

Study Start:2017-10-10
Study Completion:2027-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03206060

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Surgically inoperable participants with clinical diagnosis of PHEO/PGL who also have demonstrated disease histologically consistent with pheochromocytoma or paraganglioma (preferably confirmed by research site pathology review if initial pathology was done outside of research site, but not mandatory)
  2. * Progressive disease by RECIST 1.1 with or without symptoms within the last 12 months. NOTE: Untreated participants with existing histologic diagnoses are eligible if progression can be demonstrated
  3. * PHEO/PGL that is not associated with any known susceptibility genetic mutations for PHEO/PGL except SDHx mutation (a.k.a. "apparent sporadic"), based on documented genetic testing results obtained prior to study enrollment. PHEO/PGL that is associated with non-SDHx mutations such as VHL, NF1, and RET will not be eligible for this study.
  4. * Both metastatic and inoperable primary-only participants are eligible.
  5. * Must have presence of SSTR+ disease as documented by positive Ga-68-DOTATATE PET scan within 12 weeks of anticipated treatment.
  6. * Positivity of Ga-68-DOTATATE PET scan defined as having at least one lesion that is greater than or equal to 10 mm in diameter with uptake that is higher than or equal to liver and is qualitatively higher and distinguishable from background activity.
  7. * Measurable disease as defined by RECIST 1.1
  8. * Age greater than or equal to 18
  9. * Karnofsky Performance Score greater than or equal to 60 or ECOG Performance Status of 2 or better.
  10. * Able to understand and willings to sign informed consent.
  11. * Ability and willingness to obtain all required scans per study schedule.
  12. * Negative serum pregnancy test for women of child-bearing potential. NOTE: A female is not of childbearing potential if a prior history of hysterectomy with bilateral oophorectomy or other procedure has rendered the participant surgically sterile, or \>2 years since last menstruation.
  13. * Female participants of childbearing potential and male participants who are not surgically sterile or with female partners of childbearing potential must agree to use effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel) prior to study entry, for the duration of study participation, and for 4 months for male participants or 7 months for female participants (10 half-lives of Lu-177) after the last dose of Lu-177-DOTATATE.
  14. * Must have outside endocrinologist/medical oncologist who can follow the participant after receiving PRRT (NIH only requirement).
  15. * Patients with secreting tumors must be receiving adequate pharmacologic catecholamine blockade as determined by the treating physician.
  16. * Ineligible, unable to or unwilling to receive standard first line therapy for PHEO/PGL.
  1. * Creatinine clearance \<50 mL/min calculated by the MDRD method, eventually confirmed by measured creatinine clearance (or measured glomerular filtration rate (GFR) using plasma clearance methods.
  2. * Serum albumin less than or equal to 3.0 g/dL unless prothrombin time is within the normal range.
  3. * Liver dysfunction as evidenced by Child s Class C Liver Disease or worse Alternatively, AST or ALT \> 2.5 times institutional upper limit of normal (ULN) unless liver metastases are present, in which case up to 5 times ULN would be allowed.
  4. * Hb \< 8.0 g/dL; WBC \< 2.0 x 10\^9/L (or Absolute Neutrophil Count \< 1000); Platelets \< 100 x 10\^9/L
  5. * In participants with symptoms of congestive heart failure, New York Heart Association (NYHA) classification of grade III or IV
  6. * Pregnancy or lactation.
  7. * Prior anti-tumoral radionuclide therapy with unsealed sources. Prior therapy with sealed radioactive sources such as brachytherapy will be allowed.
  8. * Prior local radiation therapy would be allowed as long as there is at least one non-irradiated index lesion.
  9. * Known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks, prior to enrollment in the study. Patients with a history of brain metastases must have a head CT or MRI scan with contrast to document stable disease for at least 24 weeks prior to enrolment in the study.
  10. * Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and proven no evidence of recurrence for 5 years.
  11. * Patients who participated in any therapeutic clinical study with an investigational agent within the last 30 days.
  12. * Patients may be on somatostatin analogue therapy (e.g. but not only limited to sandostatin or lanreotide therapy). However, therapy with somatostatin analogues should not be initiated or altered within 3 months of study enrolment. Patients on short term octreotide may have dose held for 24 hours prior to Lu-177-DOTATATE therapy. Those on long acting octreotide therapy will receive treatment at 1 to 5 days prior to their next cold octreotide dose, in order to prevent competition for the receptor.
  13. * Patient weight \> 400 lbs (table limit for PET scanner) or per local institutional standard for participating sites.
  14. * Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, hypertension (\>180/110), arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  15. * Inability to tolerate at least one modality of diagnostic anatomic imaging, such as CT or MRI.

Contacts and Locations

Study Contact

Joy Zou, R.N.
CONTACT
(240) 760-6153
zoujh@mail.nih.gov
Frank I Lin, M.D.
CONTACT
(240) 760-6166
frank.lin2@nih.gov

Principal Investigator

Frank I Lin, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

Univ of California San Francisco Medical Center at Mission Bay
San Francisco, California, 94158
United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States
Univ or Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Frank I Lin, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-10-10
Study Completion Date2027-01-01

Study Record Updates

Study Start Date2017-10-10
Study Completion Date2027-01-01

Terms related to this study

Keywords Provided by Researchers

  • Hypertension
  • Catecholamine
  • Familial Syndromes
  • Somatostatin Receptors
  • Ionizing Radiation

Additional Relevant MeSH Terms

  • Pheochromocytoma
  • Paraganglioma
  • Neuroendocrine Tumors
  • Neuroendocrine Neoplasms