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| ID | Type | Description | Link |
|---|---|---|---|
| 1346001 | Other Identifier | Northwestern University IRB |
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Due to lack of funding, phase II of study was not completed.
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| Name | Class |
|---|---|
| Robert H. Lurie Cancer Center | OTHER |
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Monoclonal antibodies such as rituximab and yttrium Y 90 ibritumomab tiuxetan can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Motexafin gadolinium may increase the effectiveness of yttrium Y 90 ibritumomab tiuxetan by making the cancer cells more sensitive to the drug.
This phase I/II trial is studying the side effects and best dose of motexafin gadolinium when administered with rituximab and yttrium Y 90 ibritumomab tiuxetan and to see how well they work in treating patients with stage II, stage III, or stage IV relapsed or refractory non-Hodgkin's lymphoma.
This is a phase I, dose-escalation study of motexafin gadolinium followed by a phase II study. Patients are stratified according to extent of lymphomatous involvement (≤ 5% vs > 5 but ≤ 24% of cellular elements).
Cohorts of 3-6 patients in each stratum receive escalating doses of motexafin gadolinium until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity (DLT) OR the dose preceding that at which 2 of 3 or 3 of 6 patients experience DLT.
Patients are followed weekly for 3 months and then monthly for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituxan and 90Yttrium-Zevalin plus MGd | Experimental | Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituxan | Drug | Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limiting Toxicities (DLT) | The number of Dose Limiting Toxicities (DLT) observed in patients treated with Motexafin Gadolinium at different dose levels in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was used to determine the Maximum Tolerated Dose (MTD) to be used for phase II of the study. The number of dose-limiting toxicities observed in each cohort of patients determined whether to continue dose escalation. Each cohort = at least 3 patients. All toxicities will be graded according to the NCI Common Toxicity Criteria, version 2.0, with a DLT defined as any of the following: Grade 3 or 4 non-hematologic toxicity (other than grade 3 nausea or vomiting). Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and thrombocytopenia either lasting longer than 14 days-Grade 4 duration will be measured (in days) from the first date in grade 4 to last date in grade 4 after nadir (growth factor and transfusion independent, respectively). | Weekly during treatment and continuing up through Day 90 |
| Maximum Tolerated Dose (MTD) | The maximum tolerated dose (MTD) of Motexafin Gadolinium in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was determined using a modified Fibonacci phase I study design (with patient allocation based on amount of lymphoma bone marrow involvement) and will be used in phase II of the study. The MTD will be that dose at which 0/3 or 1/6 patients or 2/9 experience a Dose Limiting Toxicity (DLT), with the next higher dose level provoking DLT in 2/3 or 3/6 or 4/9 patients. | Weekly during treatment and continuing up through Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-lymphoma Efficacy | To assess the anti-lymphoma efficacy of the combination of MGd and 90Yttrium-Zevalin therapy. Disease response to treatment was categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or complete response/unconfirmed (CRu). The overall response rate (ORR) was then calculated. The time to treatment failure (TTF), overall survival (OS), and duration of response were determined. |
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DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one of the following:
Low-grade or follicular B-cell non-Hodgkin's lymphoma (NHL)
The following histologies are eligible:
Relapsed or refractory after 2 prior treatment regimens or 1 anthracycline regimen
Diffuse large B-cell NHL or mantle cell lymphoma in first or second relapse
Transformed NHL, defined as low-grade NHL transformed to diffuse large B-cell lymphoma, with no more than 1 relapse since transformation
Age 18 and over Recovered from prior immunotherapy Life expectancy At least 3 months Recovered from prior chemotherapy
Exclusion criteria:
No major bleeding within the past 4 weeks No uncontrolled hypertension No stroke within the past 4 weeks
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| Name | Affiliation | Role |
|---|---|---|
| Andrew M. Evens, DO, MS | Northwestern University | Principal Investigator |
| Leo I. Gordon, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611-3013 | United States | ||
| Jesse B. Brown Veterans Affairs Medical Center |
For phase I, patients were allocated according to the amount of bone marrow involvement they expressed (either ≤ 5% or ≤ 6-24% involvement). Initially, patients were accrued to the first cohort of the ≤ 5% involvement group. After that group moved to the second cohort, patients in the ≤ 6-24% involvement group were enrolled to the first cohort.
The study was open to accrual between the dates of September 10, 2003 and October 31, 2007 with the first patient enrolled on study October 28, 2003. Patients were recruited from the outpatient Hematology-Oncology clinic at Northwestern Medical Faculty Foundation, and the in-patient Hematology-Oncology service of Northwestern Memorial Hospital.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase I: 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement. |
| FG001 | Phase I: 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement | In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd). |
| FG002 | Phase I: 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd). |
| FG003 | Phase I: 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement | After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd). |
| FG004 | Phase I: 3.5 mg/kg MGd & 6-24% Bone Marrow Involvement | After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd). |
| FG005 | Phase I: 5.0 mg/kg MGd & 6-24% Bone Marrow Involvement | After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd). |
| FG006 | Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement | After completion of the Phase I portion, patients were enrolled to the maximum tolerated dose (MTD) group of 5.0 mg/kg MGd for \ |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase I: 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose Limiting Toxicities (DLT) | The number of Dose Limiting Toxicities (DLT) observed in patients treated with Motexafin Gadolinium at different dose levels in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was used to determine the Maximum Tolerated Dose (MTD) to be used for phase II of the study. The number of dose-limiting toxicities observed in each cohort of patients determined whether to continue dose escalation. Each cohort = at least 3 patients. All toxicities will be graded according to the NCI Common Toxicity Criteria, version 2.0, with a DLT defined as any of the following: Grade 3 or 4 non-hematologic toxicity (other than grade 3 nausea or vomiting). Grade 4 vomiting despite maximal antiemetic support. Grade 4 neutropenia and thrombocytopenia either lasting longer than 14 days-Grade 4 duration will be measured (in days) from the first date in grade 4 to last date in grade 4 after nadir (growth factor and transfusion independent, respectively). | Only patients enrolled during the phase I portion of this trial were analyzed for this outcome measure. | Posted | Number | Dose-Limiting Toxicities | Weekly during treatment and continuing up through Day 90 |
Adverse events were collected daily during the treatment period (Days 1 through 11), then weekly up to 30 days after the last dose of study treatment, and then monthly up to 90 days after the last dose of study treatment.
1 patient was withdrawn from the study without receiving any Zevalin (Y90) and thus was not considered evaluable for toxicity/adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort (2.5 mg/kg MGd) was open only to those with ≤ 5% of bone marrow involvement. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death - not otherwise specified | General disorders | CTCAE (3.0) | Non-systematic Assessment | Patient became deceased - no other information available. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alkaline phosphatase | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
Due to a lack of adequate funding, we were unable to complete 2 of the secondary objectives for this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Office Administrator | Northwestern University | 312-695-1301 | cancertrials@northwestern.edu |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| C437683 | motexafin gadolinium |
| D007267 | Injections |
| C422802 | ibritumomab tiuxetan |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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|
|
| motexafin gadolinium | Drug | Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8. |
|
|
| 111Indium-Zevalin and 90Yttrium-Zevalin | Drug | Patients receive motexafin gadolinium IV over 30-60 minutes on days 1-4 and 8-11. At least 1 hour after motexafin gadolinium administration, patients receive rituximab IV over 3-4 hours on days 1 and 8. After rituximab administration, patients receive indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients undergo gamma camera scanning on days 1, 2*, 4*, and 7 and dosimetry on days 2, 4, and 7. If safe biodistribution is demonstrated, patients receive yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes (after rituximab administration) on day 8. |
|
|
| At 1, 3 and 6 months |
| Study and Describe the Bio-locationization of Motexafin Gadolinium (MGd) in Tumors Using MRIs | To study the tumor-specific bio-localization of MGd in lymphoma through magnetic resonance imaging (MRI) in a subset of patients. The first 2 patients of each cohort will have MRI imaging to measure if signal intensity, a correlate for MGd uptake, is increased in known areas of lymphomatous involvement. | At baseline (pre-treatment) and on Day 4 of treatment |
| Correlative Laboratory Studies | To explore correlative laboratory studies of MGd (ie, uptake of MGd by peripheral mononuclear cells, effect of MGd upon peripheral lymphocyte subset populations). | On Day 1 and 4 |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Phase I: 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement |
In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd). |
| BG002 | Phase I: 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd). |
| BG003 | Phase I: 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement | After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd). |
| BG004 | Phase II: 5.0 mg/kg MGd & </= 5% Bone Marrow Involvement | After completion of the Phase I portion, patients were enrolled to the maximum tolerated dose (MTD) group of 5.0 mg/kg MGd for \ |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | All patients were assigned race at the time of registration according to how their race is listed in their medical records. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | 2.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | For the phase I dose-escalation portion, patients were allocated based on the amount of lymphoma bone marrow involvement. Initially, enrollment to the first cohort was open only to those with ≤ 5% of bone marrow involvement. |
| OG001 | 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement | In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to the first cohort on the Lesser Bone Marrow Involvement arm, patients with 6-24% bone marrow involvement could be enrolled to the first cohort in the Greater Bone Marrow Involvement arm. |
| OG002 | 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | Following completion of enrollment to the first cohort, patients with ≤ 5% bone marrow involvement were then enrolled to the second cohort (3.5 mg/kg MGd). |
| OG003 | 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement | Following completion of enrollment to the second cohort, patients with ≤ 5% bone marrow involvement were then enrolled to the third cohort (5.0 mg/kg MGd). |
| OG004 | 3.5 mg/kg MGd & 6-24% Bone Marrow Involvement | Following completion of enrollment to their first cohort, patients with 6-24% bone marrow involvement were then enrolled to their second cohort (3.5 mg/kg MGd). |
| OG005 | 5.0 mg/kg MGd & 6-24% Bone Marrow Involvement | Following completion of enrollment to their second cohort, patients with 6-24% bone marrow involvement were then enrolled to their third cohort (5.0 mg/kg MGd). |
|
|
| Primary | Maximum Tolerated Dose (MTD) | The maximum tolerated dose (MTD) of Motexafin Gadolinium in combination with Rituxan, Indium-Zevalin, and 90Yttrium-Zevalin was determined using a modified Fibonacci phase I study design (with patient allocation based on amount of lymphoma bone marrow involvement) and will be used in phase II of the study. The MTD will be that dose at which 0/3 or 1/6 patients or 2/9 experience a Dose Limiting Toxicity (DLT), with the next higher dose level provoking DLT in 2/3 or 3/6 or 4/9 patients. | Phase I arms were evaluable for this outcome measure. | Posted | Number | mg/kg | Weekly during treatment and continuing up through Day 90 |
|
|
|
| Secondary | Anti-lymphoma Efficacy | To assess the anti-lymphoma efficacy of the combination of MGd and 90Yttrium-Zevalin therapy. Disease response to treatment was categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or complete response/unconfirmed (CRu). The overall response rate (ORR) was then calculated. The time to treatment failure (TTF), overall survival (OS), and duration of response were determined. | All phase I and phase II patients were evaluated for response to treatment (anti-lymphoma efficacy). For the cohort with ≤ 5% bone marrow involvement treated at the 5.0 mg/kg MGd dose, results are based on 6 phase I patients and 8 phase II patients. 2 patients were determined not to be evaluable as they did not reach response time points. | Posted | Count of Participants | Participants | At 1, 3 and 6 months |
|
|
|
| Secondary | Study and Describe the Bio-locationization of Motexafin Gadolinium (MGd) in Tumors Using MRIs | To study the tumor-specific bio-localization of MGd in lymphoma through magnetic resonance imaging (MRI) in a subset of patients. The first 2 patients of each cohort will have MRI imaging to measure if signal intensity, a correlate for MGd uptake, is increased in known areas of lymphomatous involvement. | Data was not collected for analysis of this outcome measure due to lack of funding. | Posted | At baseline (pre-treatment) and on Day 4 of treatment |
|
|
| Secondary | Correlative Laboratory Studies | To explore correlative laboratory studies of MGd (ie, uptake of MGd by peripheral mononuclear cells, effect of MGd upon peripheral lymphocyte subset populations). | Data not collected for analysis of this outcome measure. | Posted | On Day 1 and 4 |
|
|
| 0 |
| 7 |
| 7 |
| 7 |
| EG001 | 2.5 mg/kg MGd & 6-24% Bone Marrow Involvement | In the phase I portion of the study, following completion of enrollment of patients with ≤ 5% bone marrow involvement to their first cohort (2.5 mg/kg MGd), patients with 6-24% bone marrow involvement could be enrolled to their first cohort (2.5 mg/kg MGd). | 1 | 3 | 3 | 3 |
| EG002 | 3.5 mg/kg MGd & ≤ 5% Bone Marrow Involvement | After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd). | 2 | 6 | 6 | 6 |
| EG003 | 5.0 mg/kg MGd & ≤ 5% Bone Marrow Involvement | After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 5% Bone Marrow Involvement group, patients with ≤ 5% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd). | 4 | 13 | 13 | 13 |
| EG004 | 3.5 mg/kg MGd & 6-24% Bone Marrow Involvement | After completion of the first cohort (2.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the second cohort (3.5 mg/kg MGd). | 0 | 0 | 0 | 0 |
| EG005 | 5.0 mg/kg MGd & 6-24% Bone Marrow Involvement | After completion of the second cohort (3.5 mg/kg MGd) in the ≤ 6-24% Bone Marrow Involvement group, patients with ≤ 6-24% Bone Marrow Involvement were enrolled to the third cohort (5.0 mg/kg MGd). | 0 | 0 | 0 | 0 |
|
| Death due to disease progression | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment | Patient experienced disease progression ultimately resulting in death. |
|
| Febrile neutropenia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Infection with grade 3 or 4 neutrophils | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Obstruction, GU: left ureter | Renal and urinary disorders | CTCAE (3.0) | Non-systematic Assessment | Patient had undergone stent replacement prior to registration on-study - event was determined to be related to that and not to study treatment. |
|
| Ventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Non-systematic Assessment | Determined to be unrelated to study - occurred when patient discontinuing heart medication which resulted in heart failure. |
|
|
| Alopecia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Bicarbonate, serum-low | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Bilirubin | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Creatinine | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Cytokine release syndrome (infusion reaction) | Investigations | CTCAE (3.0) | Systematic Assessment | Attributed as related to study treatment. |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dermal change: skin discoloration | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Skin turned a green color. Attributed as related to study treatment. |
|
| Dermatology - Other: blister | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| FEV1 | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment | Attributed as probably related to study treatment. |
|
| Fever (in absence of infection) | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| GGT | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Heartburn/dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hemorrhage - gums | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypercalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Hypokalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Hypophosphatemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Leukocytes | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Mood alteration - anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Neutrophils | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - chest/thorax not otherwise specified | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - dysuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Pain - lacrimal | Eye disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pain - myalgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Pain - pelvic | Reproductive system and breast disorders | CTCAE (3.0) | Systematic Assessment |
|
| Petechiae | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Phlebitis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Platelets | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Proteinuria | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Attributed as related to study treatment. |
|
| Rash | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal - Other (hematuria) | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sweating | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Taste alteration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Transaminases - AST/ALT | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Urinary frequency | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Urinary rentention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Attributed as possibly related to study treatment. |
|
| Weight gain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| Partial Response (PR) |
|
| Stable Disease (SD) |
|
| Progressive Disease (PD) |
|
| Complete Response/Uncofirmed (CRu) |
|