Trial Outcomes & Findings for Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed) (NCT NCT00424554)

NCT ID: NCT00424554

Last Updated: 2017-06-07

Results Overview

An experimental assay was developed to measure MGMT levels.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2017-06-07

Participant Flow

Participant milestones

Measure	Temozolomide (TMZ) Temozolomide 75 mg/m\^2 daily for 14 days prior to surgery. As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion.	No Intervention No pre-surgery treatment with temozolomide
Overall Study STARTED	34	6
Overall Study COMPLETED	34	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)

Baseline characteristics by cohort

Measure	Temozolomide (TMZ) n=34 Participants Temozolomide 75 mg/m\^2 daily for 14 days prior to surgery. As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion.	No Intervention n=6 Participants No pre-surgery treatment with temozolomide	Total n=40 Participants Total of all reporting groups
Age, Customized	34 Participants n=5 Participants	6 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	4 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	2 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment Canada	34 participants n=5 Participants	6 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: All participants for which a MGMT activity assay could be performed

An experimental assay was developed to measure MGMT levels.

Outcome measures

Measure	Temozolomide (TMZ) n=33 Participants Temozolomide 75 mg/m\^2 daily for 14 days prior to surgery. As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion.	No Intervention n=5 Participants No pre-surgery treatment with temozolomide
MethylGuanine-DNA MethylTransferase [MGMT] Activity Measured From the Tumor Tissue During Surgery	333.7 fmol/mg of proteins Standard Deviation 288.5	105.1 fmol/mg of proteins Standard Deviation 155

SECONDARY outcome

Timeframe: 12 months

Grade 3 was defined as severe per Common Terminology Criteria for Adverse Events (CTCAE).

Grade 4 was defined as life-threatening per CTCAE.

Outcome measures

Measure	Temozolomide (TMZ) n=34 Participants Temozolomide 75 mg/m\^2 daily for 14 days prior to surgery. As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion.	No Intervention n=6 Participants No pre-surgery treatment with temozolomide
Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities Grade 3	4 participants	0 participants
Safety: Number of Participants Who Experienced Grade 3 or 4 Toxicities Grade 4	0 participants	0 participants

SECONDARY outcome

Timeframe: 12 months

An AE was defined as any event which was adverse, including what were commonly described as adverse or undesirable experiences, adverse events, adverse reactions, side effects, or death due to any cause associated with, or observed in conjunction with the use of a drug, biological product, or device in humans, whether or not considered related to the use of that product. Additionally, any event which was associated with, or observed in conjunction with product overdose whether accidental or intentional, or product abuse and/or withdrawal was also considered an AE.

Outcome measures

Measure	Temozolomide (TMZ) n=34 Participants Temozolomide 75 mg/m\^2 daily for 14 days prior to surgery. As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion.	No Intervention n=6 Participants No pre-surgery treatment with temozolomide
Tolerability: Number of Participants Discontinuing Treatment Due to Adverse Events (AE)	0 participants	0 participants

SECONDARY outcome

Timeframe: 14 days

No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 14 days

No data available: at the time of tumor collection, the temozolomide levels were below the detection limits of the assay.

Outcome measures

Outcome data not reported

Adverse Events

Temozolomide

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

No Intervention

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Temozolomide n=34 participants at risk Temozolomide 75 mg/m\^2 daily for 14 days prior to surgery. As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion.	No Intervention n=6 participants at risk No pre-surgery treatment with temozolomide
Blood and lymphatic system disorders LYMPHOPENIA	5.9% 2/34 • Number of events 2	0.00% 0/6
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/34	16.7% 1/6 • Number of events 1
Gastrointestinal disorders DIARRHOEA	0.00% 0/34	16.7% 1/6 • Number of events 1
General disorders PAIN	0.00% 0/34	16.7% 1/6 • Number of events 1
Infections and infestations URINARY TRACT INFECTION	5.9% 2/34 • Number of events 2	16.7% 1/6 • Number of events 1
Injury, poisoning and procedural complications POSTOPERATIVE FEVER	0.00% 0/34	16.7% 1/6 • Number of events 1
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/34	16.7% 1/6 • Number of events 1
Metabolism and nutrition disorders HYPERGLYCAEMIA	2.9% 1/34 • Number of events 1	16.7% 1/6 • Number of events 1
Metabolism and nutrition disorders HYPOKALAEMIA	0.00% 0/34	16.7% 1/6 • Number of events 1
Metabolism and nutrition disorders HYPONATRAEMIA	0.00% 0/34	16.7% 1/6 • Number of events 1
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	2.9% 1/34 • Number of events 1	16.7% 1/6 • Number of events 1
Nervous system disorders COMPLEX PARTIAL SEIZURES	0.00% 0/34	16.7% 1/6 • Number of events 1
Nervous system disorders CONVULSION	0.00% 0/34	16.7% 1/6 • Number of events 2
Nervous system disorders HEMIPARESIS	5.9% 2/34 • Number of events 2	16.7% 1/6 • Number of events 1
Nervous system disorders SPEECH DISORDER	2.9% 1/34 • Number of events 1	16.7% 1/6 • Number of events 1
Nervous system disorders VISUAL FIELD DEFECT	11.8% 4/34 • Number of events 4	0.00% 0/6
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/34	16.7% 1/6 • Number of events 1
Skin and subcutaneous tissue disorders RASH	5.9% 2/34 • Number of events 3	16.7% 1/6 • Number of events 1
Skin and subcutaneous tissue disorders SKIN IRRITATION	0.00% 0/34	16.7% 1/6 • Number of events 1
Vascular disorders THROMBOSIS	0.00% 0/34	16.7% 1/6 • Number of events 1

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The principal investigator (PI) agrees not to publish or publicly present any interim results of the Study without prior written consent of the sponsor. The PI further agrees to provide 45 days written notice to the sponsor prior to submission for publication or presentation to permit the sponsor to review, without limitation, including editorial rights. If the parties disagree, the PI agrees to meet with the sponsor to discuss and resolve any such issues or disagreement.
• Publication restrictions are in place

Restriction type: OTHER