Trial Outcomes & Findings for Treatment of Tumors of the Choroid Plexus Epithelium (NCT NCT00500890)
NCT ID: NCT00500890
Last Updated: 2020-02-27
Results Overview
To compare the survival times after cyclophosphamide based treatment with survival times after carboplatin based treatment in chroid plexus tumors patients. For analysis, there will be no difference between death by tumor progression, treatment related (toxic) reasons or unrelated reasons.
TERMINATED
PHASE3
2 participants
After randomization until the end of the observation or the death of the patient
2020-02-27
Participant Flow
This study received IRB approval August 3, 2005 and was opened to recruitment September 2, 2005. The study remained open to recruitment until December 9, 2009. The study was terminated by the local IRB on December 14, 2017.
Participant milestones
| Measure |
Carboplatin + Etoposide + Vincristine
Carboplatin 350 mg/m\^2 by vein, Over 2 Hours x 2 Days. Etoposide 100 mg/m\^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.
Carboplatin: 350 mg/m\^2 by vein, Over 2 Hours x 2 Days
Etoposide: 100 mg/m\^2 by vein, Over 1 Hour x 5 Days
Vincristine: 1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5
Radiation Therapy: Radiation treatment over a period of about 6 weeks.
|
Cyclophosphamide + Etoposide + Vincristine
Cyclophosphamide 1 g/m\^2 by vein, Over 1 Hour x 2 Days. Etoposide 100 mg/m\^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.
Cyclophosphamide: 1 g/m\^2 by vein, Over 1 Hour x 2 Days
Etoposide: 100 mg/m\^2 by vein, Over 1 Hour x 5 Days
Vincristine: 1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5
Radiation Therapy: Radiation treatment over a period of about 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Tumors of the Choroid Plexus Epithelium
Baseline characteristics by cohort
| Measure |
Carboplatin + Etoposide + Vincristine
n=1 Participants
Carboplatin 350 mg/m\^2 by vein, Over 2 Hours x 2 Days. Etoposide 100 mg/m\^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.
Carboplatin: 350 mg/m\^2 by vein, Over 2 Hours x 2 Days
Etoposide: 100 mg/m\^2 by vein, Over 1 Hour x 5 Days
Vincristine: 1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5
Radiation Therapy: Radiation treatment over a period of about 6 weeks.
|
Cyclophosphamide + Etoposide + Vincristine
n=1 Participants
Cyclophosphamide 1 g/m\^2 by vein, Over 1 Hour x 2 Days. Etoposide 100 mg/m\^2 by vein, Over 1 Hour x 5 Days. Vincristine 1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5. Radiation treatment over a period of about 6 weeks.
Cyclophosphamide: 1 g/m\^2 by vein, Over 1 Hour x 2 Days
Etoposide: 100 mg/m\^2 by vein, Over 1 Hour x 5 Days
Vincristine: 1.5 mg/m\^2 (by vein)IV Push Over 15 Minutes On Day 5
Radiation Therapy: Radiation treatment over a period of about 6 weeks.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: After randomization until the end of the observation or the death of the patientPopulation: No data were collected due to early termination.
To compare the survival times after cyclophosphamide based treatment with survival times after carboplatin based treatment in chroid plexus tumors patients. For analysis, there will be no difference between death by tumor progression, treatment related (toxic) reasons or unrelated reasons.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: No data were collected due to early terminationPopulation: No data were collected due to early termination
To determine the prognostic relevance of histological atypia and SV40 in choroid plexus tumors. Prognosis of tumors with or without SV40 will be compared using overall survival time as endpoint. Kaplan Meier survival estimates and log rank tests as statistical methods similar to the analysis of primary objective.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: No data were collected due to early terminationPopulation: No data were collected due to early termination.
To compare the resectability of choroid plexus tumors after two blocks of cyclophosphamide based therapy treatment with the resectability after two blocks of carboplatin based treatment. Success of surgery after first 2 cycles of chemotherapy will be compared between two treatment arms. Percentage of patients with secondary complete remission from those with incomplete primary resection, will be used to analyze question. Tumor with CR and tumors which could be completely resected after two cycles of chemotherapy will be counted together. Frequency will be compared a month the 2 treatment arms using Chi-square test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: No data were collected due to early terminationPopulation: No data were collected due to early termination
To compare response rates of incompletely resected choroid plexus tumors to two blocks of cyclophosphamide based therapy treatment with the response rates after two blocks of carboplatin based treatment.
Outcome measures
Outcome data not reported
Adverse Events
Carboplatin + Etoposide + Vincristine
Cyclophosphamide + Etoposide + Vincristine
Serious adverse events
| Measure |
Carboplatin + Etoposide + Vincristine
n=1 participants at risk
Study participants randomized to receive chemotherapy regimine containing Carboplatin, Etoposide and Vincristine.
|
Cyclophosphamide + Etoposide + Vincristine
n=1 participants at risk
Study participants randomized to receive chemotherapy regimine containing Cyclophosphamide, Etoposide and Vincristine.
|
|---|---|---|
|
Infections and infestations
Neutropenic Fever
|
0.00%
0/1 • Adverse events were collected from time of first dosing of protocol defined treatment until 30 days after last dose of study treatment.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from time of first dosing of protocol defined treatment until 30 days after last dose of study treatment.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Richard Gorlick, MD/Division Head, Pediatrics Administration
UT MD Anderson Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place