A Study on the Safety and Effectiveness of Temozolomide for Neoadjuvant Treatment of PPGL

Launched by PEKING UNION MEDICAL COLLEGE HOSPITAL · May 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called temozolomide to see if it can help patients with pheochromocytoma and paraganglioma (PPGL), which are types of tumors that can be challenging to treat. The trial focuses on using temozolomide before surgery, with the hope that it will make tumors that cannot currently be removed become operable, thereby reducing the risks associated with surgery. This phase II trial is currently recruiting participants aged 10 to 70 who have been diagnosed with PPGL and are facing high surgical risks.

To participate, individuals need to provide consent and meet certain health criteria, such as having normal blood counts and liver function. Participants can expect to take temozolomide orally and will be monitored closely throughout the study. It's important to note that pregnant or nursing women cannot participate, and those with other serious health issues may also be excluded. Overall, this trial aims to improve treatment options for patients facing difficult surgical decisions due to their tumors.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Provide written informed consent.
• • Age 10-70 years old
• • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
• • The patient is diagnosed as pheochromocytoma or paraganglioma which is unresectable with R0 surgery, or extensive and thus maybe requiring resection of important organs, or Inoperable due to heart and other complications, or with very high surgical risk.
• • Estimated life expectancy longer than 6 months.
• • Confirmed non-pregnancy and lactation. During the entire study period and within 6 months after the last administration, the subjects and their spouses are willing to use efficient contraceptive measures.
• * Laboratory requirements:
• • Absolute granulocyte count (AGC) greater than 1.5 x 109/L;
• • Platelet count greater than 80 x 109/L; 3) Hemoglobin greater than 90g/L;
• • Serum bilirubin less than 1.5 x upper limit of normal (ULN);
• • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than 2.5 x ULN; Serum creatinine less than 1.5 x ULN or creatinine clearance (CCr)≥60ml/min;
• • Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%).
• Exclusion Criteria:
• • Have other tumors.
• • Patients were treated with other antitumor agents.
• • Pregnant or nursing women.
• • A history of allergic reactions to temozolomide or dacarbazine.
• • Severe myelosuppression or abnormal coagulation.
• • Severe liver and kidney insufficiency.
• • Bowel obstruction or other conditions that interfere with taking medication.