Trial Outcomes & Findings for Carboplatin and Temozolomide (Temodar) for Recurrent and Symptomatic Residual Brain Metastases (NCT NCT00362817)

Results Overview

Response was evaluated by MRI Criteria (MacDonald Criteria). The MacDonald criteria for determining tumor progression is determined through assessing the increase in size of an enhancing tumor on consecutive MRI scans and clinical assessment. Complete response occurs when there is a disappearance of all enhancing tumor on consecutive MRI scans at least one month apart. Partial response occurs at a \>50% reduction in size of enhancing tumor on consecutive MRI scans at least one month apart. Progressive disease occurs when there is a \>25% increase in size of enhancing tumor on consecutive MRI scans. Stable disease occurs in all remaining situations.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

17 participants

Primary outcome timeframe

up to 1 year

Results posted on

2017-06-01

Participant Flow

All patients had received prior systemic chemotherapy for the primary tumor

Participant milestones

Participant milestones
Measure	Temozolomide & Intra-Arterial (IA) Carboplatin Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks. carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Carboplatin and Temozolomide (Temodar) for Recurrent and Symptomatic Residual Brain Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Temozolomide & Intra-Arterial (IA) Carboplatin n=17 Participants Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks. carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 1 year

Response was evaluated by MRI Criteria (MacDonald Criteria). The MacDonald criteria for determining tumor progression is determined through assessing the increase in size of an enhancing tumor on consecutive MRI scans and clinical assessment. Complete response occurs when there is a disappearance of all enhancing tumor on consecutive MRI scans at least one month apart. Partial response occurs at a \>50% reduction in size of enhancing tumor on consecutive MRI scans at least one month apart. Progressive disease occurs when there is a \>25% increase in size of enhancing tumor on consecutive MRI scans. Stable disease occurs in all remaining situations.

Outcome measures

Outcome measures
Measure	Temozolomide & Intra-Arterial (IA) Carboplatin n=14 Participants Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks. carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.
Affects of Response Rate of Chemotherapy With Intra-arterial Carboplatin and Oral Temozolomide	42.8 percentage of patients with response

SECONDARY outcome

Timeframe: up to 60 weeks

Responses to treatment was determined by comparing new enhanced MRI scans with those obtained at the previous evaluation (i.e., 2 treatment cycles ago) or with the pre-IA chemotherapy baseline scan, if it is the first follow-up MRI scan during treatment. MRI is the neuro-imaging modality of choice, since it is more accurate than CT for small tumors, multiple tumors, and tumors in the posterior fossa.58 The methodology used (techniques and equipment) must be identical for all scans. Lesions should be measured as the largest diameter seen on scan and the largest diameter perpendicular to that dimension.

Outcome measures

Outcome measures
Measure	Temozolomide & Intra-Arterial (IA) Carboplatin n=14 Participants Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks. carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.
Analyze Patients Time to Progression	22.6 weeks Interval 8.0 to 60.0

SECONDARY outcome

Timeframe: up to 64 weeks

From the time of protocol initiation

Outcome measures

Outcome measures
Measure	Temozolomide & Intra-Arterial (IA) Carboplatin n=14 Participants Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks. carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.
Determine the Overall Survival of Patients	25.2 weeks Interval 12.0 to 64.0

SECONDARY outcome

Timeframe: up to 1 year

To determine the cause of death (i.e., CNS tumor versus systemic disease progression) in patients after treatment.

Outcome measures

Outcome measures
Measure	Temozolomide & Intra-Arterial (IA) Carboplatin n=14 Participants Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks. carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.
Determine the Cause of Death of Patients After Treatment CNS tumor	0 patients
Determine the Cause of Death of Patients After Treatment Systemic disease progression	7 patients

SECONDARY outcome

Timeframe: up to 24 weeks

To determine the incidence and severity of CNS toxicity in patients treated with intra-arterial carboplatin and oral temozolomide.

Outcome measures

Outcome measures
Measure	Temozolomide & Intra-Arterial (IA) Carboplatin n=14 Participants Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks. carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.
The Incidence and Severity of Centeral Nervous System (CNS) Toxicities	0 patients

SECONDARY outcome

Timeframe: up to 2 years

Population: Quality of Life Assessment was not done.

To determine the impact of treatment on quality of life.

Outcome measures

Outcome data not reported

Adverse Events

Temozolomide & Intra-Arterial (IA) Carboplatin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Herbert Newton,

The Ohio State University Medical Center and James Cancer Hospital & Solove Research Inst.

Phone: 614-293-4448

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place