Trial Outcomes & Findings for Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma (NCT NCT00335140)

Last Updated: 2023-07-03

Results Overview

Assessed by the ECOG-ACRIN data manager based upon local review of images and data sent by the local sites. Treatment response was determined by calculating the sum of the maximal cross section in 2 separate axes using enhancing lesion(s) on CT or MRI imaging. The same imaging modality was to be used throughout assessment. Complete response was defined as the disappearance of all contrast enhancing tumor size on CT or MRI, patient was off all glucocorticoids, and resolution of all meningeal and vitreous involvement if present. Response must have lasted at least 4 weeks.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).

Results posted on

2023-07-03

Participant Flow

Participants were recruited from ECOG-ACRIN member institutions starting 12/21/2006 and accrued its first patient on 08/23/2007. The study was suspended 2/24/2010 for interim analysis. After the interim analysis, it was determined that the goals of the study had been met and the study was closed on 4/12/2013.

Participant milestones

Participant milestones
Measure	Rituximab + Standard Chemotherapy rituximab cytarabine dexamethasone leucovorin calcium methotrexate procarbazine hydrochloride vincristine sulfate
Overall Study STARTED	26
Overall Study Eligible	25
Overall Study Treated	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Rituximab + Standard Chemotherapy rituximab cytarabine dexamethasone leucovorin calcium methotrexate procarbazine hydrochloride vincristine sulfate
Overall Study Ineligible	1

Baseline Characteristics

Rituximab and Combination Chemotherapy in Treating Patients With Primary Central Nervous System Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab + Standard Chemotherapy n=25 Participants rituximab cytarabine dexamethasone leucovorin calcium methotrexate procarbazine hydrochloride vincristine sulfate
Age, Customized Age · Age < 60 years	15 Participants n=5 Participants
Age, Customized Age · Age ≥ 60 years	10 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	24 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants
ECOG Performance Status 0	1 Participants n=5 Participants
ECOG Performance Status 1	15 Participants n=5 Participants
ECOG Performance Status 2	5 Participants n=5 Participants
ECOG Performance Status 3	4 Participants n=5 Participants
Neurologic Function Status No symptoms	0 Participants n=5 Participants
Neurologic Function Status Minor symptoms	11 Participants n=5 Participants
Neurologic Function Status Moderate symptoms/fully active	5 Participants n=5 Participants
Neurologic Function Status Moderate symptoms/less than fully active	7 Participants n=5 Participants
Neurologic Function Status Severe neurologic symptoms	2 Participants n=5 Participants
Cerebrovascular Disease Never	21 Participants n=5 Participants
Cerebrovascular Disease Symptomatic or on medication	4 Participants n=5 Participants
Other Medical Problems at Baseline Never	9 Participants n=5 Participants
Other Medical Problems at Baseline Symptomatic or on medication	7 Participants n=5 Participants
Other Medical Problems at Baseline Past history of	7 Participants n=5 Participants
Other Medical Problems at Baseline Missing/unknown	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).

Population: Eligible, treated patients

Outcome measures

Outcome measures
Measure	Rituximab + Standard Chemotherapy n=25 Participants rituximab cytarabine dexamethasone leucovorin calcium methotrexate procarbazine hydrochloride vincristine sulfate
Complete Response Rate - Locally Reviewed	64 percentage of participants Interval 42.5 to 82.0

Adverse Events

Rituximab + Standard Chemotherapy

Serious events: 24 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rituximab + Standard Chemotherapy n=26 participants at risk Rituximab + high dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine. Patients with meningeal involvement will receive additional methotrexate and leucovorin.
Blood and lymphatic system disorders Anemia	23.1% 6/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Leukocytes decreased	65.4% 17/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Lymphopenia	38.5% 10/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Neutrophils decreased	76.9% 20/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Platelets decreased	19.2% 5/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
General disorders Fatigue	15.4% 4/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Skin and subcutaneous tissue disorders Rash/desquamation	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Dysphagia	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Respiratory, thoracic and mediastinal disorders Muco/stomatitis by exam, pharynx	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Muco/stomatitis (symptom) esophagus	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Respiratory, thoracic and mediastinal disorders Muco/stomatitis (symptom) pharynx	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Perforation, colon	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Perforation, stomach	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Blood and lymphatic system disorders Febrile neutropenia	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Infections and infestations Infection Gr0-2 neut, upper aerodig	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Alanine aminotransferase increased	26.9% 7/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Aspartate aminotransferase increased	15.4% 4/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hypocalcemia	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hyperglycemia	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hypophosphatemia	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hypokalemia	30.8% 8/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hyponatremia	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Musculoskeletal and connective tissue disorders Nonneuropathic lower extr muscle weak	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Ataxia	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Psychiatric disorders Confusion	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Psychiatric disorders Depression	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Neuropathy CN VI lateral deviation eye	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Neuropathy-motor	11.5% 3/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Neuropathy-sensory	11.5% 3/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Esophagus, pain	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Musculoskeletal and connective tissue disorders Extremity-limb, pain	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Head/headache	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Musculoskeletal and connective tissue disorders Joint, pain	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Musculoskeletal and connective tissue disorders Muscle, pain	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Oral cavity, pain	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Respiratory, thoracic and mediastinal disorders Throat/pharynx/larynx, pain	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Respiratory, thoracic and mediastinal disorders Hypoxia	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Injury, poisoning and procedural complications Vascular access,Thrombosis/embolism	3.8% 1/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Vascular disorders Thrombosis/thrombus/embolism	11.5% 3/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.

Other adverse events

Other adverse events
Measure	Rituximab + Standard Chemotherapy n=26 participants at risk Rituximab + high dose methotrexate, leucovorin, vincristine, procarbazine, dexamethasone, and cytarabine. Patients with meningeal involvement will receive additional methotrexate and leucovorin.
Eye disorders Vision-blurred	11.5% 3/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Eye disorders Tearing	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	19.2% 5/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Blood and lymphatic system disorders Anemia	88.5% 23/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Leukocytes decreased	92.3% 24/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Lymphopenia	46.2% 12/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Neutrophils decreased	42.3% 11/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Platelets decreased	73.1% 19/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Vascular disorders Hypertension	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Vascular disorders Hypotension	19.2% 5/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
General disorders Fatigue	80.8% 21/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Psychiatric disorders Insomnia	23.1% 6/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
General disorders Rigors/chills	15.4% 4/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Weight gain	11.5% 3/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Skin and subcutaneous tissue disorders Alopecia	19.2% 5/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Skin and subcutaneous tissue disorders Rash/desquamation	15.4% 4/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Injury, poisoning and procedural complications Wound - non-infectious	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Anorexia	23.1% 6/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Constipation	34.6% 9/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Diarrhea w/o prior colostomy	30.8% 8/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Dry mouth	11.5% 3/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Dysphagia	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Dyspepsia	11.5% 3/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	11.5% 3/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	19.2% 5/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Nausea	50.0% 13/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Taste disturbance	15.4% 4/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Vomiting	26.9% 7/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Skin and subcutaneous tissue disorders Petechiae	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
General disorders Edema limb	19.2% 5/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hypoalbuminemia	53.8% 14/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Alkaline phosphatase increased	19.2% 5/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Alanine aminotransferase increased	57.7% 15/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Aspartate aminotransferase increased	42.3% 11/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Acidosis	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Blood bilirubin increased	23.1% 6/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hypercalcemia	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hypocalcemia	57.7% 15/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Creatinine increased	50.0% 13/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hyperglycemia	46.2% 12/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hypermagnesemia	11.5% 3/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hypomagnesemia	15.4% 4/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hypophosphatemia	11.5% 3/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hyperkalemia	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hypokalemia	61.5% 16/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Metabolism and nutrition disorders Hyponatremia	50.0% 13/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Investigations Metabolic/Laboratory-other	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Musculoskeletal and connective tissue disorders Arthritis	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
General disorders Extremity-lower (gait/walking)	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Dizziness	15.4% 4/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Psychiatric disorders Anxiety	23.1% 6/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Psychiatric disorders Depression	15.4% 4/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Neuropathy-motor	19.2% 5/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Neuropathy-sensory	38.5% 10/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Psychiatric disorders Personality	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Speech impairment	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Tremor	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Abdomen, pain	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Musculoskeletal and connective tissue disorders Extremity-limb, pain	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Nervous system disorders Head/headache	26.9% 7/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Musculoskeletal and connective tissue disorders Muscle, pain	23.1% 6/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Gastrointestinal disorders Oral cavity, pain	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 2/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Respiratory, thoracic and mediastinal disorders Dyspnea	26.9% 7/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.
Renal and urinary disorders Urinary frequency/urgency	15.4% 4/26 • Assessed every 2 weeks during treatment and once for the 30 days following the last dose of protocol drug, or until the initiation of subsequent treatment, whichever comes first.

Additional Information

Lode Swinnen, MD

Johns Hopkins Cancer Center

Phone: (410) 955-8603

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place