Trial Outcomes & Findings for Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma (NCT NCT00288067)
NCT ID: NCT00288067
Last Updated: 2014-10-06
Results Overview
A group of 3 patients would start treatment ast the dose of 900mg/m\^2 BID, and if none of the 3 experienced a DLT, another 3 would then be treated at that dose. Dose Limiting Toxicity was defined as any related toxicity of grade 4 or 5 on or before the completion of 4 weeks of therapy. Per response evaluation criteria 1999 Cheson Response Criteria for Malignant Lymphoma (CHESON99) for target lesions assessed by either CT or MRI: Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; Complete Response Unconfirmed (CRU): Complete disappearance of all measurable and non-measurable disease, with the exception of all residual nodal masses \>1.5cm in Greatest Transverse Diameter (GTD) reduced by 75% in Sum of the Product of the greatest Diameters (SPD); Partial Response (PR): 50% decrease in the SPD.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
32 participants
Primary outcome timeframe
Number of participants that experienced a dose-limiting toxicity
Results posted on
2014-10-06
Participant Flow
Participant milestones
| Measure |
Fenretinide and Rituximab
PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
pharmacological study : Correlative studies
rituximab : Given IV
fenretinide : Given PO
|
|---|---|
|
Overall Study
STARTED
|
32
|
|
Overall Study
COMPLETED
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fenretinide and Rituximab in Treating Patients With B-Cell Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Fenretinide and Rituximab
n=32 Participants
PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
pharmacological study : Correlative studies
rituximab : Given IV
fenretinide : Given PO
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=99 Participants
|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 10 • n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
32 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Number of participants that experienced a dose-limiting toxicityPopulation: 7 participants were analyzed in the Rituximab Naive arm and 16 participants were analyzed in the Rituximab Pre Treated Arm.
A group of 3 patients would start treatment ast the dose of 900mg/m\^2 BID, and if none of the 3 experienced a DLT, another 3 would then be treated at that dose. Dose Limiting Toxicity was defined as any related toxicity of grade 4 or 5 on or before the completion of 4 weeks of therapy. Per response evaluation criteria 1999 Cheson Response Criteria for Malignant Lymphoma (CHESON99) for target lesions assessed by either CT or MRI: Complete Response (CR): Complete disappearance of all measurable and non-measurable disease; Complete Response Unconfirmed (CRU): Complete disappearance of all measurable and non-measurable disease, with the exception of all residual nodal masses \>1.5cm in Greatest Transverse Diameter (GTD) reduced by 75% in Sum of the Product of the greatest Diameters (SPD); Partial Response (PR): 50% decrease in the SPD.
Outcome measures
| Measure |
Fenretinide and Rituximab
n=23 Participants
PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
pharmacological study : Correlative studies
rituximab : Given IV
fenretinide : Given PO
|
Fenretinide and Rituximab (Rituximab Pre Treated)
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
|
|---|---|---|
|
Safety, in Terms of Dose-limiting Toxicity (DLT) of 2 Daily Doses of Single Agent Fenretinide (Phase I)
|
0 participants
|
—
|
PRIMARY outcome
Timeframe: Up to 7 yearsPopulation: No subjects in Phase 1 met the DLT, therefore Phase II was conducted at 900mg/m2. Of the 32 subjects, 4 subjects were not evaluable for disease response (2 subjects in Phase 1 and 2 subjects in Phase 2).
The trial was stratified into rituximab-naïve and rituximab pre-treated patients, and the target response rates for these groups were expected to be 30% and 10%, respectively. The numbers reported below are subjects who achieved a response of partial response or better.
Outcome measures
| Measure |
Fenretinide and Rituximab
n=7 Participants
PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
pharmacological study : Correlative studies
rituximab : Given IV
fenretinide : Given PO
|
Fenretinide and Rituximab (Rituximab Pre Treated)
n=16 Participants
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
|
|---|---|---|
|
Response Rates of B-Non-Hodgkin Lymphoma to the Combination of Rituximab and Fenretinide (Phase II)
|
4 participants
|
0 participants
|
Adverse Events
Fenretinide and Rituximab
Serious events: 6 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fenretinide and Rituximab
n=32 participants at risk
PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
pharmacological study : Correlative studies
rituximab : Given IV
fenretinide : Given PO
|
|---|---|
|
Immune system disorders
Allergic Reaction
|
3.1%
1/32 • Number of events 1
|
|
Vascular disorders
Hypotension
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other, specify, Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10
|
3.1%
1/32 • Number of events 1
|
|
Cardiac disorders
Acute Coronary Syndrome
|
3.1%
1/32 • Number of events 1
|
|
Infections and infestations
Wound Infection
|
3.1%
1/32 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
1/32 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify, Papillary Thy
|
3.1%
1/32 • Number of events 1
|
Other adverse events
| Measure |
Fenretinide and Rituximab
n=32 participants at risk
PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.
PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
pharmacological study : Correlative studies
rituximab : Given IV
fenretinide : Given PO
|
|---|---|
|
Eye disorders
Night Blindness
|
56.2%
18/32 • Number of events 53
|
|
Gastrointestinal disorders
Abdominal Distention
|
6.2%
2/32 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal Pain
|
21.9%
7/32 • Number of events 16
|
|
Investigations
Alanine aminotransferase increased
|
9.4%
3/32 • Number of events 3
|
|
Investigations
Alkaline phosphatase increased
|
6.2%
2/32 • Number of events 3
|
|
Immune system disorders
Allergic Reaction
|
9.4%
3/32 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
2/32 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
31.2%
10/32 • Number of events 22
|
|
Metabolism and nutrition disorders
Anorexia
|
21.9%
7/32 • Number of events 7
|
|
Psychiatric disorders
Anxiety
|
6.2%
2/32 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
4/32 • Number of events 4
|
|
Investigations
Aspartate aminotransferase increased
|
15.6%
5/32 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.2%
2/32 • Number of events 3
|
|
Investigations
Blood Bilirubin Increased
|
15.6%
5/32 • Number of events 7
|
|
Eye disorders
Blurred Vision
|
12.5%
4/32 • Number of events 7
|
|
Blood and lymphatic system disorders
Bone marrow hypocellular
|
15.6%
5/32 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
9.4%
3/32 • Number of events 5
|
|
Injury, poisoning and procedural complications
Bruising
|
6.2%
2/32 • Number of events 3
|
|
Eye disorders
Cataract
|
9.4%
3/32 • Number of events 8
|
|
General disorders
Chills
|
6.2%
2/32 • Number of events 2
|
|
Investigations
Cholesterol High
|
6.2%
2/32 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
18.8%
6/32 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
4/32 • Number of events 8
|
|
Investigations
Creatinine Increased
|
21.9%
7/32 • Number of events 22
|
|
Immune system disorders
Cytokine release syndrome
|
21.9%
7/32 • Number of events 18
|
|
Psychiatric disorders
Depression
|
9.4%
3/32 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea
|
37.5%
12/32 • Number of events 20
|
|
Nervous system disorders
Dizziness
|
21.9%
7/32 • Number of events 7
|
|
Eye disorders
Dry Eye
|
15.6%
5/32 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
28.1%
9/32 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
12.5%
4/32 • Number of events 5
|
|
General disorders
Edema Limbs
|
18.8%
6/32 • Number of events 9
|
|
Eye disorders
Eye disorders - Other, specify, yellowing/discoloration of lights
|
46.9%
15/32 • Number of events 17
|
|
Eye disorders
Eye disorders - Other, specify, Altered color perception
|
12.5%
4/32 • Number of events 13
|
|
General disorders
Fatigue
|
34.4%
11/32 • Number of events 33
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.2%
2/32 • Number of events 2
|
|
General disorders
Fever
|
6.2%
2/32 • Number of events 2
|
|
Eye disorders
Flashing Lights
|
12.5%
4/32 • Number of events 4
|
|
Gastrointestinal disorders
Flatulance
|
9.4%
3/32 • Number of events 4
|
|
Injury, poisoning and procedural complications
Fracture
|
12.5%
4/32 • Number of events 6
|
|
Vascular disorders
Hot Flashes
|
18.8%
6/32 • Number of events 6
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
15.6%
5/32 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
4/32 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypernatremia
|
6.2%
2/32 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
34.4%
11/32 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
50.0%
16/32 • Number of events 31
|
|
Metabolism and nutrition disorders
Hypokalemia
|
15.6%
5/32 • Number of events 12
|
|
Metabolism and nutrition disorders
Hyponatremia
|
18.8%
6/32 • Number of events 7
|
|
Vascular disorders
Hypotension
|
9.4%
3/32 • Number of events 3
|
|
Psychiatric disorders
Insomnia
|
15.6%
5/32 • Number of events 5
|
|
Investigations
Lymphocyte Count Decreased
|
28.1%
9/32 • Number of events 31
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
4/32 • Number of events 5
|
|
Gastrointestinal disorders
Nausea
|
9.4%
3/32 • Number of events 4
|
|
Investigations
Neutrophil Count Decreased
|
28.1%
9/32 • Number of events 16
|
|
General disorders
Pain
|
6.2%
2/32 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
6.2%
2/32 • Number of events 2
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
18.8%
6/32 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
9.4%
3/32 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
28.1%
9/32 • Number of events 20
|
|
Investigations
Platelet Count Decreased
|
31.2%
10/32 • Number of events 29
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
2/32 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
62.5%
20/32 • Number of events 22
|
|
Infections and infestations
Sinusitis
|
12.5%
4/32 • Number of events 4
|
|
Vascular disorders
Thromboembolic Event
|
6.2%
2/32 • Number of events 2
|
|
Infections and infestations
Upper Respiratory Infection
|
12.5%
4/32 • Number of events 4
|
|
Renal and urinary disorders
Urinary Frequency
|
9.4%
3/32 • Number of events 4
|
|
Infections and infestations
Urinary Tract Infection
|
6.2%
2/32 • Number of events 3
|
|
Infections and infestations
Vaginal Infection
|
6.2%
2/32 • Number of events 3
|
|
Investigations
White Blood Cell Decreased
|
28.1%
9/32 • Number of events 27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60