177Lutetium-DOTA-Octreotate Therapy in Somatostatin Receptor-Expressing Neuroendocrine Neoplasms

NCT ID: NCT01237457

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-27
• Study Completion Date: 2017-07-25

Brief Summary

This is a phase II treatment protocol evaluating 177Lu-DOTATATE therapy for somatostatin receptor-expressing cancers including, but not limited to, those arising from the neural crest and involving such organs as the lungs, breast, gastrointestinal tract, skin, and endocrine (examples: pheochromocytoma, medullary carcinoma of the thyroid, non-radioiodine avid differentiated thyroid cancer, melanoma, renal cell, Merkel cell, paraganglioma, small cell lung, Carcinoid, and pancreatic islet cell malignancies).

Conditions

Neuroendocrine Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Patients with somatostatin receptor-expressing neuroendocrine neoplasms will receive up to 200 mCi of 177Lu-DOTATATE every 6-11 weeks, preferably 6-9 weeks to a cumulative dose of 800 mCi.

Group Type: EXPERIMENTAL

177Lu-DOTATATE

Intervention Type: DRUG

Patients will receive 200mCi dose of 177Lu Dotatate

Interventions

177Lu-DOTATATE

Patients will receive 200mCi dose of 177Lu Dotatate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with biopsy proven Gastroenteropancreatic (GEP tumors including bronchial carcinoids)
• Presence of somatostatin-receptors on the known tumor lesions demonstrated by OctreoScan within 6 months of the first dose of radiolabelled octreotate therapy. The uptake on the OctreoScan should be at least as high as normal liver uptake on planar imaging.
• Life Expectancy greater than 12 weeks.
• Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dL and a measured creatinine clearance (or measured GFR using plasma clearance methods, not gamma camera based) of ≥ 50ML/min.
• Hemoglobin (Hgb) concentration ≥ 5.5 mmol/L (≥ 8.9 g/dL); WBC ≥ 2*109/L (2000/mm3); platelets ≥ 100*109/L (100*103/mm3).
• Total Bilirubin ≤ 3X UNL.
• Serum Albumin > 30g/L or serum albumin ≤ 30g/L but normal prothrombin time.
• All patients must have a Karnofsky performance status of at least 60%
• Patients must be greater than 18 years of age. Patients younger than 18 years will be presented to FDA for compassionate use on a case by case basis

Exclusion Criteria

• Possible surgery with curative intent.
• Surgery, radiotherapy, chemotherapy or other investigational therapy within 3 months of the start of therapy.
• Patients with known brain metastases unless these metastases have been treated and stabilized for at least 6 months prior to study start. Patients with a history of brain metastases must have a head CT with contrast to document stable disease prior to study start.
• Uncontrolled congestive heart failure.
• Any subject who is taking concomitant medications which decrease renal function (such as aminoglycoside antibiotics).
• Any subject receiving therapy with somatostatin analogues, unless the dose has been stable for at least 3 months prior to the first cycle in this study and the disease status during these 4 months has been documented by modified RECISTS criteria as described in this study
• Any subject receiving therapy with short acting somatostatin analogues in whom these analogues cannot be interrupted for 12 hours before and 12 hours after the administration of the radio labelled somatostatin analogues, or any subject who receives therapy with long-acting somatostatin analogues in whom these analogues cannot be interrupted for at least 6 weeks before the administration of the radio labeled somatostatin analogues, unless the uptake on the Octreoscan during continued somatostatin analogue medication is at least as high as normal liver uptake on planar imaging.
• In patients 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.
• Subjects with another significant medical, psychiatric, or surgical condition, currently uncontrolled by treatment, which may interfere with completion of the study.
• Prior radiation therapy to more than 25% of the bone marrow.
• Female patients who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 60 days (10 half lives of 177Lu after the last treatment, or male patients who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 60 days after the last treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Excel Diagnostics and Nuclear Oncology Center

OTHER

Sponsor Role: collaborator

Ebrahim S Delpassand

OTHER

Sponsor Role: lead

Responsible Party

Ebrahim S Delpassand

Chairman and Medical Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ebrahim S Delpassand, M.D

Role: PRINCIPAL_INVESTIGATOR

Excel Diagnostics and Nuclear Oncology Center

Locations

Excel Diagnostics and Nuclear Oncology Center

Houston, Texas, United States

Countries

United States

Other Identifiers

78,256

Identifier Type: -

Identifier Source: org_study_id