Clinical trial · Interventional
The Efficacy and Safety of Temozolomide in Patients With MPPGL
The Efficacy and Safety of Temozolomide in Patients With Metastatic Pheochromocytoma or Paraganglioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Paraganglioma, Malignant | Paraganglioma | ONTOLOGY_EXACT | 0.85 |
| Pheochromocytoma Malignant | Extra-Adrenal Paraganglioma | PROBABILISTIC | 0.70 |
| Pheochromocytoma, Metastatic | Adrenal Gland Pheochromocytoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide capsule | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Temozolomide
- description
- TMZ was given orally per day for 5 days, every 28 days until disease progression or intolerable toxicities.
- interventionNames
- Drug: Temozolomide capsule
Primary outcomes (2)
- measure
- disease control rate (DCR)
- timeFrame
- At the end of Cycle 3 (each cycle is 28 days)
- description
- Defined for all patients whose tumor met the criteria of CR or PR or stable disease(SD)
- measure
- objective response rate (ORR)
- timeFrame
- At the end of Cycle 3 (each cycle is 28 days)
- description
- Defined for all patients whose tumor met the criteria of Complete Response (CR)and Partial Response (PR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available