Trial Outcomes & Findings for Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma (NCT NCT00098774)
NCT ID: NCT00098774
Last Updated: 2016-07-06
Results Overview
Response is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
4 months
Results posted on
2016-07-06
Participant Flow
Between October 2004 and November 2009, 47 participants were recruited at 12 CALGB sites.
Three participants were excluded from analysis because of failure to meet eligibility criteria or to receive protocol therapy.
Participant milestones
| Measure |
Intensive Combination Chemo & Immunotherapy
Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Intensive Combination Chemo & Immunotherapy
Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Disease Progression
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Failed (to respond) during induction
|
4
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Rituximab and Combination Chemotherapy in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
Baseline characteristics by cohort
| Measure |
Intensive Combination Chemo & Immunotherapy
n=44 Participants
Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 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
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsResponse is assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Complete response requires disappearance of all evidence of disease.
Outcome measures
| Measure |
Intensive Combination Chemo & Immunotherapy
n=44 Participants
Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
|
|---|---|
|
Complete Response Rate After Remission Induction
|
66 percentage of participants
Interval 50.0 to 80.0
|
SECONDARY outcome
Timeframe: 4 yearsPercentage of patients who were progression free at 4 years. The 4-year progression free rate was estimated using the Kaplan Meier method. Relapse was assessed by investigator according to Revised Response Criteria for Malignant Lymphoma. Progression required a 25% increase of previous area of gadolinium enhancement, appearance of new areas of T1 gadolinium enhancement or new appearance of malignant cells in the spinal fluid or new tumor appearance in other sites of the body
Outcome measures
| Measure |
Intensive Combination Chemo & Immunotherapy
n=44 Participants
Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
|
|---|---|
|
4 Year Progression Free Rate
|
48 percentage of participants
Interval 33.0 to 63.0
|
SECONDARY outcome
Timeframe: Baseline & month 4Population: Only 14 participants had both baseline and 4 month MMSE evaluations reported.
Neurologic functioning will be assessed using the Mini-Mental Status Evaluation (MMSE), a standardized, bedside tool for evaluation of higher mental function. This assessment is based on a 30-point scale (0-30) with higher scores associated with better performance.
Outcome measures
| Measure |
Intensive Combination Chemo & Immunotherapy
n=14 Participants
Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
|
|---|---|
|
Change From Baseline in Mini-Mental Status Evaluation at 4 Months
Baseline Score
|
27 units on a scale
Interval 7.0 to 30.0
|
|
Change From Baseline in Mini-Mental Status Evaluation at 4 Months
4 month Score
|
28 units on a scale
Interval 22.0 to 30.0
|
|
Change From Baseline in Mini-Mental Status Evaluation at 4 Months
Change from Baseline
|
1 units on a scale
Interval -1.0 to 18.0
|
SECONDARY outcome
Timeframe: 4 yearsPercentage of patients who were alive at 4 years. The 4-year survival rate was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Intensive Combination Chemo & Immunotherapy
n=44 Participants
Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
|
|---|---|
|
4 Year Overall Survival Rate
|
65 percentage of participants
Interval 49.0 to 77.0
|
Adverse Events
Intensive Combination Chemo & Immunotherapy
Serious events: 15 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intensive Combination Chemo & Immunotherapy
n=44 participants at risk
Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/44 • Number of events 1
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
25.0%
11/44 • Number of events 13
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
2/44 • Number of events 2
|
|
Cardiac disorders
Cardiopulmonary arrest
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Conduction disorder
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Sinus bradycardia
|
6.8%
3/44 • Number of events 3
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.3%
1/44 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Diplopia
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Keratitis
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Vision blurred
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
6.8%
3/44 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
6/44 • Number of events 6
|
|
Gastrointestinal disorders
Ear, nose and throat examination abnormal
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
13.6%
6/44 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
15.9%
7/44 • Number of events 7
|
|
Gastrointestinal disorders
Rectal mucositis
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Small intestinal mucositis
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
11.4%
5/44 • Number of events 5
|
|
General disorders
Chills
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Disease progression
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Edema limbs
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Facial pain
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Fatigue
|
15.9%
7/44 • Number of events 7
|
|
General disorders
Fever
|
2.3%
1/44 • Number of events 1
|
|
General disorders
Localized edema
|
2.3%
1/44 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Abdominal infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Anorectal infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Lymph gland infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Opportunistic infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Peritoneal infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Rhinitis infective
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
2.3%
1/44 • Number of events 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
18.2%
8/44 • Number of events 10
|
|
Investigations
Alkaline phosphatase increased
|
2.3%
1/44 • Number of events 3
|
|
Investigations
Aspartate aminotransferase increased
|
15.9%
7/44 • Number of events 8
|
|
Investigations
Blood bilirubin increased
|
13.6%
6/44 • Number of events 6
|
|
Investigations
Creatinine increased
|
9.1%
4/44 • Number of events 4
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.3%
1/44 • Number of events 1
|
|
Investigations
INR increased
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Laboratory test abnormal
|
6.8%
3/44 • Number of events 3
|
|
Investigations
Leukocyte count decreased
|
13.6%
6/44 • Number of events 6
|
|
Investigations
Lymphocyte count decreased
|
4.5%
2/44 • Number of events 2
|
|
Investigations
Neutrophil count decreased
|
20.5%
9/44 • Number of events 10
|
|
Investigations
Platelet count decreased
|
22.7%
10/44 • Number of events 10
|
|
Investigations
Serum cholesterol increased
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Alkalosis
|
2.3%
1/44 • Number of events 1
|
|
Metabolism and nutrition disorders
Anorexia
|
6.8%
3/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
22.7%
10/44 • Number of events 10
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
2.3%
1/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
13.6%
6/44 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
13.6%
6/44 • Number of events 6
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
9.1%
4/44 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
4.5%
2/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
4.5%
2/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
15.9%
7/44 • Number of events 7
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
4.5%
2/44 • Number of events 2
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
6.8%
3/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness right-sided
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Ataxia
|
6.8%
3/44 • Number of events 4
|
|
Nervous system disorders
Cognitive disturbance
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Depressed level of consciousness
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Headache
|
4.5%
2/44 • Number of events 2
|
|
Nervous system disorders
Intracranial hemorrhage
|
4.5%
2/44 • Number of events 2
|
|
Nervous system disorders
Memory impairment
|
6.8%
3/44 • Number of events 5
|
|
Nervous system disorders
Mini mental status examination abnormal
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Neurological disorder NOS
|
6.8%
3/44 • Number of events 3
|
|
Nervous system disorders
Nystagmus
|
4.5%
2/44 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Seizure
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Speech disorder
|
2.3%
1/44 • Number of events 2
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Confusion
|
9.1%
4/44 • Number of events 5
|
|
Psychiatric disorders
Depression
|
2.3%
1/44 • Number of events 1
|
|
Psychiatric disorders
Insomnia
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Urinary retention
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
6.8%
3/44 • Number of events 3
|
|
Vascular disorders
Hypertension
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
9.1%
4/44 • Number of events 4
|
|
Vascular disorders
Vascular disorder
|
2.3%
1/44 • Number of events 1
|
Other adverse events
| Measure |
Intensive Combination Chemo & Immunotherapy
n=44 participants at risk
Induction Cycles 1-3: Methotrexate 8gm/m\^2 days 1 \& 15; Leucovorin 100 mg/m\^2 days 2 \& 16; Rituximab 375 mg/m\^2 days 3, 10, 17 \& 24 of cycle 1, days 3 \& 10 of cycle 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Induction Cycle 4: Temozolomide 150 mg/m\^2/day PO days 7-11; Methotrexate 8gm/m\^2 day 15; Leucovorin 100 mg/m\^2 day 16
Consolidation Cycle 5: Methotrexate 8gm/m\^2 days 1; Leucovorin 100 mg/m\^2 days 2; Temozolomide 150 mg/m\^2/day PO days 7-11
Consolidation Cycle 6: Cytarabine 2 g/m\^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m\^2/day starting day 14 until ANC recovers (\>= 500 for 2 consecutive days or \>= 1500 for one day)
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
15.9%
7/44 • Number of events 7
|
|
Blood and lymphatic system disorders
Hemoglobin decreased
|
68.2%
30/44 • Number of events 90
|
|
Cardiac disorders
Arrhythmia
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Atrial tachycardia
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Cardiac disorder
|
4.5%
2/44 • Number of events 4
|
|
Cardiac disorders
Edema
|
2.3%
1/44 • Number of events 3
|
|
Cardiac disorders
Palpitations
|
4.5%
2/44 • Number of events 3
|
|
Cardiac disorders
Sinus bradycardia
|
6.8%
3/44 • Number of events 4
|
|
Cardiac disorders
Sinus tachycardia
|
2.3%
1/44 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.3%
1/44 • Number of events 1
|
|
Ear and labyrinth disorders
Ear pain
|
2.3%
1/44 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
4.5%
2/44 • Number of events 3
|
|
Endocrine disorders
Cushingoid
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Diplopia
|
4.5%
2/44 • Number of events 5
|
|
Eye disorders
Dry eye syndrome
|
4.5%
2/44 • Number of events 2
|
|
Eye disorders
Eye disorder
|
6.8%
3/44 • Number of events 4
|
|
Eye disorders
Eye pain
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Flashing vision
|
6.8%
3/44 • Number of events 3
|
|
Eye disorders
Keratitis
|
2.3%
1/44 • Number of events 3
|
|
Eye disorders
Photophobia
|
2.3%
1/44 • Number of events 1
|
|
Eye disorders
Vision blurred
|
15.9%
7/44 • Number of events 16
|
|
Eye disorders
Watering eyes
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
5/44 • Number of events 5
|
|
Gastrointestinal disorders
Constipation
|
43.2%
19/44 • Number of events 37
|
|
Gastrointestinal disorders
Diarrhea
|
52.3%
23/44 • Number of events 45
|
|
Gastrointestinal disorders
Dry mouth
|
2.3%
1/44 • Number of events 6
|
|
Gastrointestinal disorders
Dyspepsia
|
13.6%
6/44 • Number of events 7
|
|
Gastrointestinal disorders
Flatulence
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
4.5%
2/44 • Number of events 2
|
|
Gastrointestinal disorders
Mucositis oral
|
36.4%
16/44 • Number of events 22
|
|
Gastrointestinal disorders
Nausea
|
81.8%
36/44 • Number of events 92
|
|
Gastrointestinal disorders
Oral hemorrhage
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Typhlitis
|
2.3%
1/44 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
56.8%
25/44 • Number of events 44
|
|
General disorders
Chest pain
|
6.8%
3/44 • Number of events 3
|
|
General disorders
Chills
|
13.6%
6/44 • Number of events 7
|
|
General disorders
Edema limbs
|
36.4%
16/44 • Number of events 36
|
|
General disorders
Fatigue
|
72.7%
32/44 • Number of events 83
|
|
General disorders
Fever
|
18.2%
8/44 • Number of events 9
|
|
General disorders
General symptom
|
4.5%
2/44 • Number of events 2
|
|
General disorders
Localized edema
|
2.3%
1/44 • Number of events 3
|
|
General disorders
Pain
|
4.5%
2/44 • Number of events 2
|
|
Immune system disorders
Hypersensitivity
|
4.5%
2/44 • Number of events 3
|
|
Infections and infestations
Bladder infection
|
4.5%
2/44 • Number of events 2
|
|
Infections and infestations
Catheter related infection
|
6.8%
3/44 • Number of events 4
|
|
Infections and infestations
Eye infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Gingival infection
|
4.5%
2/44 • Number of events 3
|
|
Infections and infestations
Infection
|
9.1%
4/44 • Number of events 4
|
|
Infections and infestations
Infection with grade 3 or 4 neutropenia
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Infectious colitis
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Nail infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Opportunistic infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Phlebitis infective
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Soft tissue infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Upper aerodigestive tract infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
2.3%
1/44 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
13.6%
6/44 • Number of events 6
|
|
Infections and infestations
Vaginal infection
|
2.3%
1/44 • Number of events 3
|
|
Infections and infestations
Wound infection
|
2.3%
1/44 • Number of events 1
|
|
Injury, poisoning and procedural complications
Bruising
|
2.3%
1/44 • Number of events 1
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
4.5%
2/44 • Number of events 2
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.3%
1/44 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
72.7%
32/44 • Number of events 85
|
|
Investigations
Alkaline phosphatase increased
|
18.2%
8/44 • Number of events 11
|
|
Investigations
Aspartate aminotransferase increased
|
75.0%
33/44 • Number of events 81
|
|
Investigations
Blood bilirubin increased
|
45.5%
20/44 • Number of events 32
|
|
Investigations
Creatinine increased
|
38.6%
17/44 • Number of events 32
|
|
Investigations
Fibrinogen decreased
|
2.3%
1/44 • Number of events 2
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.5%
2/44 • Number of events 3
|
|
Investigations
Laboratory test abnormal
|
11.4%
5/44 • Number of events 7
|
|
Investigations
Leukocyte count decreased
|
31.8%
14/44 • Number of events 39
|
|
Investigations
Lymphocyte count decreased
|
6.8%
3/44 • Number of events 7
|
|
Investigations
Neutrophil count decreased
|
70.5%
31/44 • Number of events 59
|
|
Investigations
Platelet count decreased
|
68.2%
30/44 • Number of events 52
|
|
Investigations
Serum cholesterol increased
|
4.5%
2/44 • Number of events 3
|
|
Investigations
Weight gain
|
4.5%
2/44 • Number of events 3
|
|
Investigations
Weight loss
|
6.8%
3/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
43.2%
19/44 • Number of events 43
|
|
Metabolism and nutrition disorders
Blood glucose increased
|
43.2%
19/44 • Number of events 53
|
|
Metabolism and nutrition disorders
Blood uric acid increased
|
9.1%
4/44 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
11.4%
5/44 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum albumin decreased
|
45.5%
20/44 • Number of events 41
|
|
Metabolism and nutrition disorders
Serum calcium decreased
|
31.8%
14/44 • Number of events 32
|
|
Metabolism and nutrition disorders
Serum glucose decreased
|
6.8%
3/44 • Number of events 5
|
|
Metabolism and nutrition disorders
Serum magnesium decreased
|
15.9%
7/44 • Number of events 13
|
|
Metabolism and nutrition disorders
Serum magnesium increased
|
4.5%
2/44 • Number of events 4
|
|
Metabolism and nutrition disorders
Serum phosphate decreased
|
9.1%
4/44 • Number of events 9
|
|
Metabolism and nutrition disorders
Serum potassium decreased
|
59.1%
26/44 • Number of events 68
|
|
Metabolism and nutrition disorders
Serum potassium increased
|
4.5%
2/44 • Number of events 3
|
|
Metabolism and nutrition disorders
Serum sodium decreased
|
34.1%
15/44 • Number of events 32
|
|
Metabolism and nutrition disorders
Serum sodium increased
|
9.1%
4/44 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
3/44 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.2%
8/44 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.5%
2/44 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
18.2%
8/44 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.5%
2/44 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
4/44 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.3%
1/44 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
2/44 • Number of events 4
|
|
Nervous system disorders
Ataxia
|
34.1%
15/44 • Number of events 19
|
|
Nervous system disorders
Cognitive disturbance
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
22.7%
10/44 • Number of events 11
|
|
Nervous system disorders
Dysgeusia
|
11.4%
5/44 • Number of events 10
|
|
Nervous system disorders
Encephalopathy
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Facial nerve disorder
|
2.3%
1/44 • Number of events 6
|
|
Nervous system disorders
Headache
|
47.7%
21/44 • Number of events 47
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
13.6%
6/44 • Number of events 12
|
|
Nervous system disorders
Mini mental status examination abnormal
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Neurological disorder NOS
|
6.8%
3/44 • Number of events 3
|
|
Nervous system disorders
Nystagmus
|
2.3%
1/44 • Number of events 2
|
|
Nervous system disorders
Peripheral motor neuropathy
|
15.9%
7/44 • Number of events 17
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
11/44 • Number of events 21
|
|
Nervous system disorders
Seizure
|
9.1%
4/44 • Number of events 5
|
|
Nervous system disorders
Speech disorder
|
6.8%
3/44 • Number of events 4
|
|
Nervous system disorders
Syncope
|
2.3%
1/44 • Number of events 1
|
|
Nervous system disorders
Tremor
|
6.8%
3/44 • Number of events 3
|
|
Nervous system disorders
Trigeminal nerve disorder
|
2.3%
1/44 • Number of events 6
|
|
Psychiatric disorders
Anxiety
|
25.0%
11/44 • Number of events 20
|
|
Psychiatric disorders
Confusion
|
29.5%
13/44 • Number of events 19
|
|
Psychiatric disorders
Depression
|
18.2%
8/44 • Number of events 16
|
|
Psychiatric disorders
Insomnia
|
20.5%
9/44 • Number of events 25
|
|
Psychiatric disorders
Psychosis
|
4.5%
2/44 • Number of events 2
|
|
Renal and urinary disorders
Bladder spasm
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Glomerular filtration rate decreased
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Hemorrhage urinary tract
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Proteinuria
|
4.5%
2/44 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
2.3%
1/44 • Number of events 1
|
|
Renal and urinary disorders
Urinary incontinence
|
4.5%
2/44 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/44 • Number of events 2
|
|
Renal and urinary disorders
Urogenital disorder
|
6.8%
3/44 • Number of events 5
|
|
Reproductive system and breast disorders
Vaginal hemorrhage
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
4.5%
2/44 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
6/44 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
11/44 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.4%
5/44 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
6.8%
3/44 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.8%
3/44 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
11.4%
5/44 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
2.3%
1/44 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
15.9%
7/44 • Number of events 9
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.8%
3/44 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
2.3%
1/44 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.6%
6/44 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Rash desquamating
|
47.7%
21/44 • Number of events 27
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
6.8%
3/44 • Number of events 4
|
|
Vascular disorders
Hemorrhage
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Hypertension
|
18.2%
8/44 • Number of events 13
|
|
Vascular disorders
Hypotension
|
9.1%
4/44 • Number of events 4
|
|
Vascular disorders
Phlebitis
|
2.3%
1/44 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
6.8%
3/44 • Number of events 5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60