CompletedPhase 2

The Efficacy and Safety of Temozolomide in Patients With MPPGL

China62 participantsStarted 2019-10-01

Plain-language summary

Metastatic pheochromocytoma / paraganglioma (MPP) are rare while the prognosis was poor. Temozolomide (TMZ) is a novel oral alkylation chemotherapeutic agent. TMZ has been recommended in National Comprehensive Cancer Network (NCCN) Guidelines Version 1.2019 for treating MPP patients.However, studies investigating TMZ efficacy in MPP patients are extremely limited. The largest study involved only 15 patients till date. The safety and efficacy of TMZ treatment in MPP patients need to be verified in larger studies.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion Criteria: Patients with metastatic pheochromocytomas and paragangliomas. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. Estimated life expectancy longer than 6 months. Having normal organ function as defined by hemoglobin levels ≥10 g/dL, absolute neutrophil count ≥ 1.5 x 109/L, platelet count ≥ 80 x 109/L, total bilirubin ≤1.5 institutional upper limit, aspartate aminotransferase ≤5 institutional upper limit, alanine aminotransferase ≤5 institutional upper limit, and serum creatinine \<3.0 mg/dL. Exclusion Criteria: Didn't meet eligibility for organ function. Pregnancy or breastfeeding. Uncontrolled congestive heart failure and severe infection.

What they're measuring

disease control rate (DCR)

Timeframe: At the end of Cycle 3 (each cycle is 28 days)

objective response rate (ORR)

Timeframe: At the end of Cycle 3 (each cycle is 28 days)

Trial details

NCT IDNCT05858177

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-01

View on ClinicalTrials.gov More Pheochromocytoma, Metastatic trials