Trial Outcomes & Findings for Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma (NCT NCT00588523)
NCT ID: NCT00588523
Last Updated: 2023-10-27
Results Overview
To determine the duration of disease control of newly diagnosed pure and mixed anaplastic oligodendrogliomas treated with dose-intensive chemotherapy requiring hematopoietic stem cell support.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
2 years
Results posted on
2023-10-27
Participant Flow
Participant milestones
| Measure |
Participants With Newly Diagnosed Anaplastic Oligodendroglioma
temozolomide followed by high dose busulfan and thiotepa
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Participants With Newly Diagnosed Anaplastic Oligodendroglioma
temozolomide followed by high dose busulfan and thiotepa
|
|---|---|
|
Overall Study
Not treated
|
3
|
Baseline Characteristics
Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma
Baseline characteristics by cohort
| Measure |
Participants With Newly Diagnosed Anaplastic Oligodendroglioma
n=60 Participants
temozolomide followed by high dose busulfan and thiotepa
|
|---|---|
|
Age, Continuous
|
45 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsTo determine the duration of disease control of newly diagnosed pure and mixed anaplastic oligodendrogliomas treated with dose-intensive chemotherapy requiring hematopoietic stem cell support.
Outcome measures
| Measure |
Participants With Newly Diagnosed Anaplastic Oligodendroglioma
n=60 Participants
temozolomide followed by high dose busulfan and thiotepa
|
|---|---|
|
Progession Free Survival
|
85.7 % of participants without progression
Interval 62.0 to 95.2
|
SECONDARY outcome
Timeframe: up to 2 yearsOutcome measures
| Measure |
Participants With Newly Diagnosed Anaplastic Oligodendroglioma
n=60 Participants
temozolomide followed by high dose busulfan and thiotepa
|
|---|---|
|
Number of Participants Evaluated for Toxicities
|
60 Participants
|
Adverse Events
Participants With Newly Diagnosed Anaplastic Oligodendroglioma
Serious events: 26 serious events
Other events: 57 other events
Deaths: 30 deaths
Serious adverse events
| Measure |
Participants With Newly Diagnosed Anaplastic Oligodendroglioma
n=60 participants at risk
temozolomide followed by high dose busulfan and thiotepa
|
|---|---|
|
Gastrointestinal disorders
Abdominal cramping
|
3.3%
2/60 • 2 years
|
|
Gastrointestinal disorders
Ascites
|
1.7%
1/60 • 2 years
|
|
Investigations
Bilirubin
|
1.7%
1/60 • 2 years
|
|
Blood and lymphatic system disorders
CNS Hemorrhage
|
1.7%
1/60 • 2 years
|
|
Nervous system disorders
CNS Necrosis/cystic progression
|
1.7%
1/60 • 2 years
|
|
Infections and infestations
Catheter related infection
|
1.7%
1/60 • 2 years
|
|
Gastrointestinal disorders
Colitis
|
1.7%
1/60 • 2 years
|
|
Psychiatric disorders
Confusion
|
3.3%
2/60 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
2/60 • 2 years
|
|
Psychiatric disorders
Delusions
|
1.7%
1/60 • 2 years
|
|
Skin and subcutaneous tissue disorders
Derm, skin other
|
1.7%
1/60 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
3.3%
2/60 • 2 years
|
|
Nervous system disorders
Encephalopathy
|
1.7%
1/60 • 2 years
|
|
General disorders
Fatigue
|
3.3%
2/60 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
10.0%
6/60 • 2 years
|
|
General disorders
Fever
|
8.3%
5/60 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
1.7%
1/60 • 2 years
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
1.7%
1/60 • 2 years
|
|
Vascular disorders
Hematoma
|
1.7%
1/60 • 2 years
|
|
Vascular disorders
Hypertension
|
1.7%
1/60 • 2 years
|
|
Vascular disorders
Hypotension
|
1.7%
1/60 • 2 years
|
|
Infections and infestations
Pneumonia
|
3.3%
2/60 • 2 years
|
|
Infections and infestations
Wound infection
|
1.7%
1/60 • 2 years
|
|
Infections and infestations
Infection unk ANC
|
1.7%
1/60 • 2 years
|
|
Infections and infestations
Infection w/out neutropenia
|
3.3%
2/60 • 2 years
|
|
Psychiatric disorders
Insomnia
|
1.7%
1/60 • 2 years
|
|
Investigations
White blood cells
|
1.7%
1/60 • 2 years
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
1.7%
1/60 • 2 years
|
|
Psychiatric disorders
Mood alteration/anxiety
|
1.7%
1/60 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness - whole body/general
|
3.3%
2/60 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
8.3%
5/60 • 2 years
|
|
Nervous system disorders
Neurology, other
|
1.7%
1/60 • 2 years
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
1.7%
1/60 • 2 years
|
|
Nervous system disorders
Headache
|
3.3%
2/60 • 2 years
|
|
Gastrointestinal disorders
Pancreatitis
|
1.7%
1/60 • 2 years
|
|
Investigations
Platelets
|
6.7%
4/60 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash, dequamation
|
1.7%
1/60 • 2 years
|
|
Nervous system disorders
Seizure
|
10.0%
6/60 • 2 years
|
|
Vascular disorders
Thrombosis
|
1.7%
1/60 • 2 years
|
|
Vascular disorders
Veno-Occlusive Disease
|
3.3%
2/60 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
5/60 • 2 years
|
Other adverse events
| Measure |
Participants With Newly Diagnosed Anaplastic Oligodendroglioma
n=60 participants at risk
temozolomide followed by high dose busulfan and thiotepa
|
|---|---|
|
Investigations
Platelets
|
13.3%
8/60 • 2 years
|
|
Investigations
Leukocytes
|
26.7%
16/60 • 2 years
|
|
Investigations
Neutrophils
|
21.7%
13/60 • 2 years
|
|
General disorders
Fatigue
|
10.0%
6/60 • 2 years
|
|
Investigations
Hemoglobin
|
16.7%
10/60 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
28.3%
17/60 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
5.0%
3/60 • 2 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
10/60 • 2 years
|
|
General disorders
Fever
|
5.0%
3/60 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
10/60 • 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
11.7%
7/60 • 2 years
|
|
General disorders
Edema
|
6.7%
4/60 • 2 years
|
|
Nervous system disorders
Headache
|
6.7%
4/60 • 2 years
|
|
Investigations
Lymphopenia
|
6.7%
4/60 • 2 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.7%
4/60 • 2 years
|
|
Nervous system disorders
Seizure
|
6.7%
4/60 • 2 years
|
|
Investigations
AST, SGOT
|
5.0%
3/60 • 2 years
|
|
Gastrointestinal disorders
Abdominal pain/cramping
|
5.0%
3/60 • 2 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.0%
3/60 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
5.0%
3/60 • 2 years
|
|
General disorders
Pain - other
|
5.0%
3/60 • 2 years
|
Additional Information
Dr. Thomas Kaley, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-7523
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place