NCT05858177

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2019

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
Last Updated

May 15, 2023

Status Verified

April 1, 2023

Enrollment Period

3 years

First QC Date

April 18, 2023

Last Update Submit

May 4, 2023

Conditions

Pheochromocytoma, MetastaticParaganglioma, MalignantPheochromocytoma Malignant

Keywords

Pheochromocytoma or ParagangliomametastasisTemozolomide

Outcome Measures

Primary Outcomes (2)

  • disease control rate (DCR)

    Defined for all patients whose tumor met the criteria of CR or PR or stable disease(SD)

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

  • objective response rate (ORR)

    Defined for all patients whose tumor met the criteria of Complete Response (CR)and Partial Response (PR)

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

Secondary Outcomes (3)

  • progression-free survival (PFS)

    At least 1 cycle(each cycle is 28 days), up to 100 weeks,From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

  • biochemical response

    At the end of Cycle 1 (each cycle is 28 days)

  • Incidence of adverse events

    At the end of Cycle 1 (each cycle is 28 days)

Study Arms (1)

Temozolomide

OTHER

TMZ was given orally per day for 5 days, every 28 days until disease progression or intolerable toxicities.

Drug: Temozolomide capsule

Interventions

Temozolomide capsuleDRUG

Temozolomide was given orally per day for 5 days, every 28 days until disease progression or intolerable toxicities.

Also known as: Temozolomide
Temozolomide

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Didn't meet eligibility for organ function. Pregnancy or breastfeeding. Uncontrolled congestive heart failure and severe infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

PheochromocytomaNeoplasm MetastasisParaganglioma, Extra-AdrenalParaganglioma

Interventions

Temozolomide

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DacarbazineTriazenesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Anli Tong

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

May 15, 2023

Study Start

October 1, 2019

Primary Completion

October 1, 2022

Study Completion

January 1, 2023

Last Updated

May 15, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)