NCT00049361 is a Phase 2 clinical trial of temozolomide in Brain and Central Nervous System Tumors, sponsored by Wake Forest University Health Sciences.

Who is sponsoring NCT00049361?

NCT00049361 is sponsored by Wake Forest University Health Sciences.

What drugs are being tested in NCT00049361?

Interventions in NCT00049361: temozolomide, thalidomide, radiation therapy.

What condition does NCT00049361 study?

NCT00049361 studies Brain and Central Nervous System Tumors, Unspecified Adult Solid Tumor, Protocol Specific.

Is NCT00049361 still recruiting?

NCT00049361 is currently completed. Last updated 9 September 2021.

Last reviewed 2021-09-09 · How we verify

NCT00049361

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Radiation Therapy Plus Thalidomide and Temozolomide in Treating Patients With Newly Diagnosed Brain Metastases

Completed Phase 2 Last updated 9 September 2021

What this trial tests

Phase 2 trial testing temozolomide in Brain and Central Nervous System Tumors. Completed in 7 December 2004.

Timeline

1 January 2004

Primary endpoint
7 December 2004

7 December 2004

Quick facts

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Masking	none
Primary purpose	treatment
Start date	1 January 2004
Primary completion	7 December 2004
Estimated completion	7 December 2004
Sites	5 locations across United States

Drugs / interventions tested

temozolomide (temozolomide) — full drug profile →
thalidomide (THALIDOMIDE) — full drug profile →
radiation therapy — full drug profile →

Conditions studied

Brain and Central Nervous System Tumors — all drugs for Brain and Central Nervous System Tumors →
Unspecified Adult Solid Tumor, Protocol Specific — all drugs for Unspecified Adult Solid Tumor, Protocol Specific →

Sponsor

Wake Forest University Health Sciences

Who can join

Adults 18 to 120, any sex, with Brain and Central Nervous System Tumors or Unspecified Adult Solid Tumor, Protocol Specific. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining whole-brain radiation therapy with thalidomide and temozolomide may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining whole-brain radiation therapy with thalidomide and temozolomide in treating patients who have newly diagnosed brain metastases.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Neuroinflammation as a Factor of Neurodegenerative Disease: Thalidomide Analogs as Treatments.
Jung YJ, Tweedie D, Scerba MT, Greig NH. · · 2019 · cited 116× · PMID 31867326 · DOI 10.3389/fcell.2019.00313
The clinical application of angiostatic therapy in combination with radiotherapy: past, present, future.
Hamming LC, Slotman BJ, Verheul HMW, Thijssen VL. · · 2017 · cited 26× · PMID 28364160 · DOI 10.1007/s10456-017-9546-9
Revisiting Temozolomide's role in solid tumors: Old is gold?
Matthaios D, Balgkouranidou I, Neanidis K, Sofis A, et al · · 2024 · cited 5× · PMID 38817857 · DOI 10.7150/jca.94109

Verify or expand the search:

Other trials of temozolomide

Trials testing the same drug.

NCT05052957 — hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM) · Phase 2 · recruiting
NCT04566380 — ONO-4538 Phase II Rollover Study (ONO-4538-98) · Phase 2 · recruiting
NCT04400188 — A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cel · Phase 1, PHASE2 · completed
NCT03514069 — Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma · Phase 1 · active not recruiting
NCT02168270 — Temozolomide and Ascorbic Acid in Treating Patients With Recurrent High-Grade Glioma · Phase 1 · terminated

Other recruiting trials for Brain and Central Nervous System Tumors

Currently open trials in the same condition.

NCT00978458 — Radiation Therapy With or Without Temozolomide in Treating Patients With Low-Grade Glioma · Phase 3 · active not recruiting

Other Wake Forest University Health Sciences trials

Trials by the same sponsor.

NCT07474090 — Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial · NA · not yet recruiting
NCT07282444 — A New Way to Share Radiation Therapy Plans Between Doctors, CORRECT Trial · NA · not yet recruiting
NCT06876896 — Intra-abdominal Pressure (IAP) During PFA Treatment of A-fib/ A-Flutter · NA · recruiting
NCT07227051 — Optimizing Self-Monitoring Feedback Delivery for the Treatment of Overweight and Obesity · NA · recruiting
NCT07215624 — Surgical Thromboprophylaxis Practices in Oncology Patients Within the NCORP Network, STOP-VTE Study · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00049361 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wake Forest University Health Sciences
Last refreshed: 9 September 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00049361.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing