search
Back to results

Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors

Primary Purpose

Malignant Carcinoid Tumor

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
90Y-SMT487
Sponsored by
Molecular Insight Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Carcinoid Tumor focused on measuring Malignant Carcinoid Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Life expectancy > 6 months.
  2. Subjects must have distant metastases.
  3. Subjects must be able to discontinue Sandostatin LAR treatment for at least 1 month prior to Day 1/Cycle 1; last dose of Sandostatin LAR must be 60 days or more prior to the first OctreoTher™ dose. For subcutaneous Sandostatin discontinuation should be 12 hours. Subjects taking other long acting somatostatin analogues must discontinue the analogue at least 2 times the dosing interval.
  4. Upon baseline disease assessment, all subjects must have at least 1 measurable site of disease that either has never been irradiated or if the measurable lesion has been previously irradiated; this same lesion has since demonstrated progression base don the SWOG response criteria.
  5. Subjects must state or agree with the statement that "I have symptoms from my cancer that bother me." Subjects must have failed to gain complete symptom control despite an optimal attempt at somatostatin therapy in the judgement of their physician.

Exclusion Criteria:

  1. Chemotherapy, biologic therapy or other investigational therapy within 4 weeks of Day 1.
  2. Surgery, hormonal therapy (not including somatostatin analogues) or radiation, within 2 weeks of Day 1.
  3. Subjects with know brain metastases unless these metastases have been treated and stabilized for at least six months prior to study start.
  4. Subjects who received high dose OctreoScan therapy or other radiolabelled somatostatin therapy or other systemic radiolabelled therapy (e.g. MIBG) for treatment of metastatic carcinoid.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    June 11, 2008
    Last Updated
    November 24, 2015
    Sponsor
    Molecular Insight Pharmaceuticals, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00696930
    Brief Title
    Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors
    Official Title
    A Phase II Open-label Multi-center Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    June 2008 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Molecular Insight Pharmaceuticals, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    Subjects will be screened to determine OctreoScan® uptake. And upon meeting the eligibility criteria, 90 subjects will complete a symptom assessment scale at baseline and throughout the study at specific time points. Actual treatment will consist of three six-week cycles of a fixed total dose of 13.3 GBq (360 mCi) of 90Y-SMT487. The total dose will be divided into three equal doses and administered as a single activity of 4.4 GBq (120 mCi) of 90Y-SMT487 once every six weeks for three cycles. An amino acid infusion will be administered along with each dose. Long-term follow up will occur at 6 and 12 months after Day 1/ Cycle 1. Survival will be assessed every six months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malignant Carcinoid Tumor
    Keywords
    Malignant Carcinoid Tumors

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    90Y-SMT487

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Life expectancy > 6 months. Subjects must have distant metastases. Subjects must be able to discontinue Sandostatin LAR treatment for at least 1 month prior to Day 1/Cycle 1; last dose of Sandostatin LAR must be 60 days or more prior to the first OctreoTher™ dose. For subcutaneous Sandostatin discontinuation should be 12 hours. Subjects taking other long acting somatostatin analogues must discontinue the analogue at least 2 times the dosing interval. Upon baseline disease assessment, all subjects must have at least 1 measurable site of disease that either has never been irradiated or if the measurable lesion has been previously irradiated; this same lesion has since demonstrated progression base don the SWOG response criteria. Subjects must state or agree with the statement that "I have symptoms from my cancer that bother me." Subjects must have failed to gain complete symptom control despite an optimal attempt at somatostatin therapy in the judgement of their physician. Exclusion Criteria: Chemotherapy, biologic therapy or other investigational therapy within 4 weeks of Day 1. Surgery, hormonal therapy (not including somatostatin analogues) or radiation, within 2 weeks of Day 1. Subjects with know brain metastases unless these metastases have been treated and stabilized for at least six months prior to study start. Subjects who received high dose OctreoScan therapy or other radiolabelled somatostatin therapy or other systemic radiolabelled therapy (e.g. MIBG) for treatment of metastatic carcinoid.

    12. IPD Sharing Statement

    Learn more about this trial

    Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors

    We'll reach out to this number within 24 hrs