Trial · NCT00305864

Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma

NCT00305864, Phase 1, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2013-05-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma. Trials, record NCT00305864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00305864

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Motexafin Gadolinium, Temozolomide, and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme or Gliosarcoma
NCT number: NCT00305864
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 118 participants, actual
Lead sponsor: National Cancer Institute (NCI)
Conditions: Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma
Interventions: 3-Dimensional Conformal Radiation Therapy, Motexafin Gadolinium, Temozolomide
First posted: 2006-03-22
Last updated: 2018-03-05
Results first posted: 2013-05-17

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Maximum Tolerated Dose of MGd (Phase I)	From start of radiation therapy to 90 days,	Patients were to be followed for a minimum of 90 days from the start of radiation therapy (RT) and carefully evaluated with respect to treatment morbidity. A dose limiting toxicity (DLT) was defined as a grade 4 neurologic adverse event (AE) considered to be related to treatment occurring within 21 days of the conclusion of RT. For each dose level, up to seven patients were to be accrued to assure that there would be six eligible for treatment adverse event evaluation. A dose level of MGd was considered acceptable if no more than 1 patient of the 6 experience a DLT. If the current level was considered acceptable, then dose escalation occurred. Otherwise, the preceding dose level would be declared the maximum tolerated dose (MTD). The MTD would be used for the Phase II arm. Rating scale: 0 = not the MTD, 1 = MTD
Primary	Median Overall Survival (Phase II)	From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months	Survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.
Secondary	Progression-free Survival (Phase II)	From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months.	Progression will be defined as a \> 25% increase in tumor area. Progression-free survival time was defined as the time from baseline to date of death from any cause. Patients last known to be alive are censored at date of last contact.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Maximum Tolerated Dose of MGd (Phase I)	From start of radiation therapy to 90 days,	Eligible patients who received protocol treatment.	units on a scale	NUMBER
PRIMARY	Median Overall Survival (Phase II)	From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months	All eligible patients.	Months	MEDIAN
SECONDARY	Progression-free Survival (Phase II)	From randomization to date of progression, death, or last follow-up. Analysis occurs after all patients have been potentially followed for at least 18 months. Patients were followed up to 54.3 months.	All eligible patients	months	MEDIAN

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Maximum Tolerated Dose of MGd (Phase I)	Phase I: MGd 3 mg/kg	0		units on a scale
Maximum Tolerated Dose of MGd (Phase I)	Phase I: MGd 4 mg/kg	0		units on a scale
Maximum Tolerated Dose of MGd (Phase I)	Phase I: 5 mg/kg	1		units on a scale
Median Overall Survival (Phase II)	All MGd 5mg/kg Patients (Phase I and II Arms Combined)	15.6	95% Confidence Interval 12.9 to 17.6	Months
Progression-free Survival (Phase II)	All MGd 5mg/kg Patients (Phase I and II Arms Combined)	7.6	95% Confidence Interval 5.7 to 9.6	months

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase I: MGd 3 mg/kg	7
Overall Study	STARTED	Phase I: MGd 4 mg/kg	10
Overall Study	STARTED	Phase I: MGd 5 mg/kg	7
Overall Study	STARTED	Phase II: MGd 5 mg/kg	94
Overall Study	COMPLETED	Phase I: MGd 3 mg/kg	7
Overall Study	COMPLETED	Phase I: MGd 4 mg/kg	9
Overall Study	COMPLETED	Phase I: MGd 5 mg/kg	6
Overall Study	COMPLETED	Phase II: MGd 5 mg/kg	81
Overall Study	NOT COMPLETED	Phase I: MGd 3 mg/kg	0
Overall Study	NOT COMPLETED	Phase I: MGd 4 mg/kg	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events1,164

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Phase I: MGd 3 mg/kg	4	7
other	Anemia	Blood and lymphatic system disorders	Phase I: MGd 4 mg/kg	2	9
other	Anemia	Blood and lymphatic system disorders	Phase I: MGd 5 mg/kg	2	6
other	Anemia	Blood and lymphatic system disorders	Phase II: MGd 5 mg/kg	41	81
other	Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Phase I: MGd 3 mg/kg	1	7
other	Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Phase I: MGd 4 mg/kg	2	9
other	Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Phase I: MGd 5 mg/kg	0	6
other	Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Phase II: MGd 5 mg/kg	0	81
other	Cardiac disorders - Other	Cardiac disorders	Phase I: MGd 3 mg/kg	0	7
other	Cardiac disorders - Other	Cardiac disorders	Phase I: MGd 4 mg/kg	0	9

1 to 10 of 1,164Source ClinicalTrials.gov

See all 1,164 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase I: MGd 3 mg/kg
Total, all-cause mortality	Phase I: MGd 4 mg/kg
Total, all-cause mortality	Phase I: MGd 5 mg/kg
Total, all-cause mortality	Phase II: MGd 5 mg/kg
Total, other adverse events	Phase I: MGd 3 mg/kg	7	7
Total, other adverse events	Phase I: MGd 4 mg/kg	9	9
Total, other adverse events	Phase I: MGd 5 mg/kg	6	6
Total, other adverse events	Phase II: MGd 5 mg/kg	80	81
Total, serious adverse events	Phase I: MGd 3 mg/kg	3	7
Total, serious adverse events	Phase I: MGd 4 mg/kg	6	9

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25832688	RESULT

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA021661	Radiation Therapy Oncology Group	CURRAN, WALTER J.	AMERICAN COLLEGE OF RADIOLOGY	NATIONAL CANCER INSTITUTE	1985 to 2013

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00305864

GET https://conductscience.org/api/trials/v1/NCT00305864/events?page=2

API reference For AI assistants