Trial Outcomes & Findings for Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma (NCT NCT00098865)
NCT ID: NCT00098865
Last Updated: 2014-10-07
Results Overview
Feasibility in this study was defined as completion of 6 months of thalidomide with temozolomide therapy. The corresponding therapy completion rate is defined as the proportion of patients who completed 6 months of therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
6 months
Results posted on
2014-10-07
Participant Flow
15 patients were enrolled between 2002 to 2007 at the Dana-Farber Cancer Institute.
For pediatric patients with relapsed or progressive brain tumors and neuroblastoma.
Participant milestones
| Measure |
Thalidomide and Temozolomide
Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Thalidomide and Temozolomide
Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression
|
|---|---|
|
Overall Study
Progressive Disease
|
6
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Alternative Therapy
|
1
|
Baseline Characteristics
Thalidomide and Temozolomide in Relapsed or Progressive CNS Disease or Neuroblastoma
Baseline characteristics by cohort
| Measure |
Thalidomide and Temozolomide
n=15 Participants
Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression.
|
|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=39 Participants
|
|
Disease Type
Brain Tumor
|
8 participants
n=39 Participants
|
|
Disease Type
Neuroblastoma
|
7 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analysis dataset is comprised of all treated patients.
Feasibility in this study was defined as completion of 6 months of thalidomide with temozolomide therapy. The corresponding therapy completion rate is defined as the proportion of patients who completed 6 months of therapy.
Outcome measures
| Measure |
Thalidomide and Temozolomide
n=15 Participants
Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression
temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.
thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose.
|
|---|---|
|
Therapy Completion Rate
|
.40 proportion of participants
Interval 0.19 to 0.64
|
SECONDARY outcome
Timeframe: Assessed every 8 weeks while on treatment and every 3 months for one year off-studyOverall response is the best response during 6 months of therapy measured by radiographic response. Complete Response (CR): Disappearance of all detectable tumors by imaging, if initially positive, as well as 2 consecutively negative CSF cytologic examinations (if the initial cytology was positive). Partial Response (PR): \> 50% reduction in the sum of the products of the maximum perpendicular diameter of all measurable lesions; or 2 consecutively negative CSF cytologies and a \< 50% reduction in tumor size. Stable Disease (SD): \< 50% reduction in the sum of the products of the maximum perpendicular diameters of all measurable lesions, and persistently negative or positive CSF cytology Progressive Disease (PD): \> 25% increase in the size of any measurable lesion, the appearance of a new radiographically demonstrable lesion, or the conversion of negative CSF cytology to positive, as confirmed by at least one repeat CSF cytology
Outcome measures
| Measure |
Thalidomide and Temozolomide
n=15 Participants
Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression
temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.
thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose.
|
|---|---|
|
Overall Response
Partial Response
|
1 participants
|
|
Overall Response
Stable Disease
|
9 participants
|
|
Overall Response
Progressive Disease
|
4 participants
|
|
Overall Response
Unevaluable
|
1 participants
|
SECONDARY outcome
Timeframe: Assessed after treatment discontinued every 3 months up to 2 years.Population: The analysis dataset is comprised of all treated patients.
Time from registration to death. Patients alive at last follow-up were censored.
Outcome measures
| Measure |
Thalidomide and Temozolomide
n=15 Participants
Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression
temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.
thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose.
|
|---|---|
|
Overall Survival
|
12.8 months
Interval 6.7 to 41.2
|
Adverse Events
Thalidomide and Temzolomide
Serious events: 9 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Thalidomide and Temzolomide
n=15 participants at risk
Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
13.3%
2/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Blood and lymphatic system disorders
Hematologic-other
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Eye disorders
Vision-blurred
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
General disorders
Fatigue
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Immune system disorders
Allergic reaction
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Infections and infestations
Infection w/ unk ANC catheter related
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Infections and infestations
Infection-other
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
Leukocytes
|
26.7%
4/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
Lymphopenia
|
13.3%
2/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
Neutrophils
|
33.3%
5/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
Platelets
|
26.7%
4/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
ALT, SGPT
|
13.3%
2/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Vascular disorders
Hypotension
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
Other adverse events
| Measure |
Thalidomide and Temzolomide
n=15 participants at risk
Thalidomide:
Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.
Temozolomide:
Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.
Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression.
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
53.3%
8/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Cardiac disorders
Cardiac-other
|
13.3%
2/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Ear and labyrinth disorders
Hearing-other
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
6/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
5/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Gastrointestinal disorders
Abdomen, pain
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
General disorders
Fatigue
|
53.3%
8/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
General disorders
Fever w/o neutropenia
|
20.0%
3/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
General disorders
Rigors/chills
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
General disorders
Constitutional, other
|
20.0%
3/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
General disorders
Pain-other
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Infections and infestations
Infection-other
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
Leukocytes
|
60.0%
9/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
Lymphopenia
|
33.3%
5/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
Neutrophils
|
40.0%
6/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
Platelets
|
46.7%
7/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
Alkaline phosphatase
|
13.3%
2/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
ALT, SGPT
|
53.3%
8/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
AST, SGOT
|
40.0%
6/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Investigations
Creatinine
|
20.0%
3/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Metabolism and nutrition disorders
Bicarbonate
|
53.3%
8/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
13.3%
2/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
13.3%
2/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
3/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Nervous system disorders
Ataxia
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Nervous system disorders
Memory impairment
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Nervous system disorders
Neuropathy-motor
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Nervous system disorders
Neuropathy-sensory
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Nervous system disorders
Neurologic-other
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Nervous system disorders
Head/headache
|
20.0%
3/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Psychiatric disorders
Euphoria
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Renal and urinary disorders
Incontinence urinary
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.0%
3/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
1/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
13.3%
2/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
20.0%
3/15 • Clinical assessment of drug toxicities was performed every clinic visit including CBC and serum biochemistries were collected every 2 weeks for the first 8 weeks of therapy and then monthly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60