Trial Outcomes & Findings for Mouse Cancer Cell-containing Macrobeads in the Treatment of Human Cancer (NCT NCT00283075)
NCT ID: NCT00283075
Last Updated: 2019-01-16
Results Overview
Dose limiting toxicity (DLT) was defined as: * any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction; * any Grade ≥ 3 infection and * any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction. This definition of DLT is in accord with the NCI CTCAE v3.0. Maximum tolerated dose (MTD) was to be identified if, within a cohort, \> 1 subject out of the first 3, or 2 subjects out of 5 experienced DLT. In such a case, the MTD will have been exceeded, and the administration of the study agent was to cease. MTD would not be considered to have been reached if no DLTs were observed.
COMPLETED
PHASE1
56 participants
6 months
2019-01-16
Participant Flow
Fifty-six subjects provided informed consent to participate in this study; of these 31 subjects underwent the implantation of macrobeads that contain mouse renal adenocarcinoma cells (RENCA macrobeads). The first subject was implanted on 6 April 2005 and the last subject was implanted on 1 November 2011.
Participant milestones
| Measure |
8 RENCA Macrobeads/kg Body Weight Implantation
RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
|
16 RENCA Macrobeads/kg Body Weight Implantation
RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
6
|
|
Overall Study
COMPLETED
|
25
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mouse Cancer Cell-containing Macrobeads in the Treatment of Human Cancer
Baseline characteristics by cohort
| Measure |
All Participants
n=31 Participants
All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
|
|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 8.53 • n=93 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
12 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Not Available
|
16 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 monthsDose limiting toxicity (DLT) was defined as: * any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction; * any Grade ≥ 3 infection and * any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction. This definition of DLT is in accord with the NCI CTCAE v3.0. Maximum tolerated dose (MTD) was to be identified if, within a cohort, \> 1 subject out of the first 3, or 2 subjects out of 5 experienced DLT. In such a case, the MTD will have been exceeded, and the administration of the study agent was to cease. MTD would not be considered to have been reached if no DLTs were observed.
Outcome measures
| Measure |
All Participants
n=31 Participants
All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
|
Day 14
Tumor marker response at Day 14 after the first implantation.
|
Day 21
Tumor marker response at Day 21 after the first implantation.
|
Day 28
Tumor marker response at Day 28 after the first implantation.
|
|---|---|---|---|---|
|
Maximum Tolerated Dose (MTD) of RENCA Macrobeads
|
NA RENCA Macrobeads/kg
MTD of of RENCA macrobeads has not been reached because no DLTs were observed.
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 monthsDose limiting toxicity (DLT) was defined as: * any Grade 2 allergic reaction of generalized urticaria or any other Grade ≥ 3 allergic reaction; * any Grade ≥ 3 infection and * any Grade ≥ 3 local (intraperitoneal) reaction and any Grade ≥ 3 hematologic or non- hematologic reaction. This definition of DLT is in accord with the NCI CTCAE v3.0.
Outcome measures
| Measure |
All Participants
n=25 Participants
All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
|
Day 14
n=6 Participants
Tumor marker response at Day 14 after the first implantation.
|
Day 21
Tumor marker response at Day 21 after the first implantation.
|
Day 28
Tumor marker response at Day 28 after the first implantation.
|
|---|---|---|---|---|
|
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
|
0 Participants who observed DLT
|
0 Participants who observed DLT
|
—
|
—
|
SECONDARY outcome
Timeframe: From date of RENCA macrobeads implantation until date of death from any causeOverall Survival (OS) was measured as date of first implantation to date of death of any cause, and was analyzed using the Kaplan-Meier method.
Outcome measures
| Measure |
All Participants
n=31 Participants
All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
|
Day 14
Tumor marker response at Day 14 after the first implantation.
|
Day 21
Tumor marker response at Day 21 after the first implantation.
|
Day 28
Tumor marker response at Day 28 after the first implantation.
|
|---|---|---|---|---|
|
Overall Survival
All Cancer Type
|
5.4 months
Interval 2.2 to 7.0
|
—
|
—
|
—
|
|
Overall Survival
Colorectal Cancer
|
7.0 months
Interval 1.1 to 9.7
|
—
|
—
|
—
|
|
Overall Survival
Pancreatic Cancer
|
1.1 months
Interval 1.0 to 2.2
|
—
|
—
|
—
|
|
Overall Survival
Other Cancer
|
5.7 months
Interval 2.0 to 7.0
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Prior to Implantation and Day 7, Day 14, Day 21 and Day 28 after each implantationPopulation: All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
Tumor marker response after the first implantation with RENCA macrobeads. Responders showed at least a 20% decrease from baseline in Cancer Antigen 19-9 (CA19-9) or Carcinoembryonic Antigen (CEA); Non-responders do not show at least a 20% decrease from baseline in CA19-9 or CEA.
Outcome measures
| Measure |
All Participants
n=20 Participants
All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
|
Day 14
n=21 Participants
Tumor marker response at Day 14 after the first implantation.
|
Day 21
n=13 Participants
Tumor marker response at Day 21 after the first implantation.
|
Day 28
n=17 Participants
Tumor marker response at Day 28 after the first implantation.
|
|---|---|---|---|---|
|
Tumor Marker Response
Responder
|
5 participants
|
13 participants
|
9 participants
|
10 participants
|
|
Tumor Marker Response
Non-Responder
|
15 participants
|
8 participants
|
4 participants
|
7 participants
|
Adverse Events
All Participants
Serious adverse events
| Measure |
All Participants
n=31 participants at risk
All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
|
|---|---|
|
Surgical and medical procedures
Implant site fluid collection
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Tear from mesh s/p hernia repair
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
General disorders
Intermittent fever
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
General disorders
Disease progression
|
6.5%
2/31 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
6.5%
2/31 • Number of events 2 • 6 months
|
|
General disorders
Hypophagia
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
General disorders
Pleurodesis
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
Cardiac disorders
Pericardial effusion
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
General disorders
Hypotension, poor nutrition
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
General disorders
Aspiration
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Jaundice
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Abdominal distension
|
6.5%
2/31 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.5%
2/31 • Number of events 2 • 6 months
|
|
General disorders
Transfusion
|
3.2%
1/31 • Number of events 2 • 6 months
|
|
General disorders
Dehydration
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
3.2%
1/31 • Number of events 4 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
General disorders
Asthenia
|
6.5%
2/31 • Number of events 2 • 6 months
|
|
General disorders
Blood creatinine increased
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
6.5%
2/31 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
Melena
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
General disorders
Hypotension
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
General disorders
Anemia
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Incision site pain
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
Wound complication
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
General disorders
Hyponatremia
|
6.5%
2/31 • Number of events 2 • 6 months
|
|
General disorders
Pain
|
3.2%
1/31 • Number of events 1 • 6 months
|
|
General disorders
Hydronephrosis
|
3.2%
1/31 • Number of events 2 • 6 months
|
Other adverse events
| Measure |
All Participants
n=31 participants at risk
All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
16.1%
5/31 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain
|
25.8%
8/31 • 6 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.5%
2/31 • 6 months
|
|
Gastrointestinal disorders
Ascites
|
9.7%
3/31 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
19.4%
6/31 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
19.4%
6/31 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
16.1%
5/31 • 6 months
|
|
General disorders
Asthenia
|
6.5%
2/31 • 6 months
|
|
General disorders
Fatigue
|
48.4%
15/31 • 6 months
|
|
General disorders
Inflammation
|
12.9%
4/31 • 6 months
|
|
General disorders
Pain
|
16.1%
5/31 • 6 months
|
|
General disorders
Pyrexia
|
35.5%
11/31 • 6 months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
9.7%
3/31 • 6 months
|
|
Investigations
Hemoglobin decreased
|
6.5%
2/31 • 6 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.7%
3/31 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.5%
2/31 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
2/31 • 6 months
|
|
Nervous system disorders
Dizziness
|
6.5%
2/31 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
6.5%
2/31 • 6 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.9%
4/31 • 6 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
19.4%
6/31 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.9%
4/31 • 6 months
|
|
Skin and subcutaneous tissue disorders
Umbilical erythema
|
9.7%
3/31 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place