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

• Status: Recruiting
• Trial end date: 2025-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies the effectiveness oftemozolomide in the neoadjuvant therapy oflocally advanced,or unresectable pheochromocytoma or paragangliom(PPGL). Temozolomide (TMZ) is a novel oral alkylation chemotherapeutic agent. Inthisstudy,temozolomidewill be used preoperatively in order to change unresectable tumors to resectable and reduce the high risk of surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Temozolomide

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.