CompletedPhase 2

Efficacy of Octreotide Treatment in Patients With Primary Inoperable Thymoma

Germany25 participantsStarted 2005-09

Plain-language summary

This study will investigate the efficacy of treatment with octroetide in patients with primary inoperable thymoma to reduce tumor size.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patients aged \>18 years
✓. Inoperability of thymic tumor. Inoperability is defined as at least adherence of the tumor to the neighbour organs, suspicious to infiltrate neighbour organs so that R0 resection cannot be expected.
✓. Positive result in SMS-szintigraphy,
✓. Thymomas of all WHO based histological subtypes (Rosai, 1999; Travis 2004) at Masaoka stage III based on histological examination of core biopsies or resection specimens.
✓. Patients with and without thymoma associated paraneoplastic syndrome
✓. Demonstrated tolerance to a test dose of s.c. octreotide injection at Visit 1.

✕. Performance status 0,1, or 2 (ECOG)
✕. Symptomatic cholelithiasis,
✕. Pretreatment with octreotide (longn acting release) within the 3 months
✕. Patient has received any other investigational agents within 28 days of first day of study drug dosing
✕. Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed
✕. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)

Shrinkage of tumor size and diameter of 3 respectively 6 months

Timeframe: 6 months

NCT IDNCT00332969

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-10

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patients aged \>18 years
✓. Inoperability of thymic tumor. Inoperability is defined as at least adherence of the tumor to the neighbour organs, suspicious to infiltrate neighbour organs so that R0 resection cannot be expected.
✓. Positive result in SMS-szintigraphy,
✓. Thymomas of all WHO based histological subtypes (Rosai, 1999; Travis 2004) at Masaoka stage III based on histological examination of core biopsies or resection specimens.
✓. Patients with and without thymoma associated paraneoplastic syndrome
✓. Demonstrated tolerance to a test dose of s.c. octreotide injection at Visit 1.

✕. Performance status 0,1, or 2 (ECOG)
✕. Symptomatic cholelithiasis,
✕. Pretreatment with octreotide (longn acting release) within the 3 months
✕. Patient has received any other investigational agents within 28 days of first day of study drug dosing
✕. Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other malignant disease is not allowed
✕. Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months of study)