Trial Outcomes & Findings for S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma (NCT NCT00006237)
NCT ID: NCT00006237
Last Updated: 2015-03-25
Results Overview
Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
432 participants
Primary outcome timeframe
Every three months for a year, every six months for years 2-5, annual for years 5-10
Results posted on
2015-03-25
Participant Flow
Participant milestones
| Measure |
Interferon
interferon alfa IV
|
Biochemotherapy
cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
|
|---|---|---|
|
Overall Study
STARTED
|
212
|
220
|
|
Overall Study
Eligible
|
203
|
200
|
|
Overall Study
Eligible and Treated
|
203
|
199
|
|
Overall Study
COMPLETED
|
87
|
159
|
|
Overall Study
NOT COMPLETED
|
125
|
61
|
Reasons for withdrawal
| Measure |
Interferon
interferon alfa IV
|
Biochemotherapy
cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
|
|---|---|---|
|
Overall Study
Adverse Event
|
39
|
29
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Refusal unrelated to adverse effects
|
8
|
4
|
|
Overall Study
Progression/relapse
|
54
|
2
|
|
Overall Study
Not eligible
|
9
|
20
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Not protocol specified
|
14
|
5
|
Baseline Characteristics
S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
Baseline characteristics by cohort
| Measure |
Interferon
n=203 Participants
interferon alfa
|
Biochemotherapy
n=199 Participants
cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
46 years
n=7 Participants
|
47 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
282 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
203 participants
n=5 Participants
|
199 participants
n=7 Participants
|
402 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Every three months for a year, every six months for years 2-5, annual for years 5-10Overall survival was measured from the date of registration to study until death from any cause with observations censored at the date of last contact for patients last known to be alive.
Outcome measures
| Measure |
Interferon
n=203 Participants
interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
|
Biochemotherapy
n=199 Participants
cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
|
|---|---|---|
|
5-year Overall Survival
|
56 Percent of population
|
56 Percent of population
|
PRIMARY outcome
Timeframe: Every three months for the first year, every 6 months for years 2-5, annually for years 6-10Measured from date of registration to date of first observation of progressive disease or death due to any cause.
Outcome measures
| Measure |
Interferon
n=203 Participants
interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
|
Biochemotherapy
n=199 Participants
cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
|
|---|---|---|
|
5-year Relapse-Free Survival
|
47 Percentage of population
|
38 Percentage of population
|
SECONDARY outcome
Timeframe: While on treatment, patients on the HDIFN arm were assessed weekly for the 1st month, then every 2 weeks for the 2nd month, then every 3 months therafter; patients on the biochemo arm were assessed daily for the 1st 5 days, then weekly thereafter.Population: Eligible patients who started therapy
Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
Outcome measures
| Measure |
Interferon
n=193 Participants
interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
|
Biochemotherapy
n=185 Participants
cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
|
|---|---|---|
|
Toxicity
Personality/behavioral change
|
1 Participants
|
0 Participants
|
|
Toxicity
Petechiae/purpura
|
0 Participants
|
1 Participants
|
|
Toxicity
Platelet transfusion
|
0 Participants
|
5 Participants
|
|
Toxicity
Pruritus
|
1 Participants
|
3 Participants
|
|
Toxicity
Rash/desquamation
|
4 Participants
|
10 Participants
|
|
Toxicity
Renal failure
|
0 Participants
|
1 Participants
|
|
Toxicity
Reportable adverse event, NOS
|
1 Participants
|
1 Participants
|
|
Toxicity
Respiratory infect w/ neutrop
|
0 Participants
|
2 Participants
|
|
Toxicity
Rigors/chills
|
2 Participants
|
1 Participants
|
|
Toxicity
SGOT (AST) increase
|
18 Participants
|
7 Participants
|
|
Toxicity
SGPT (ALT) increase
|
32 Participants
|
8 Participants
|
|
Toxicity
Seizures
|
0 Participants
|
2 Participants
|
|
Toxicity
Sensory neuropathy
|
0 Participants
|
2 Participants
|
|
Toxicity
Stomatitis/pharyngitis
|
0 Participants
|
1 Participants
|
|
Toxicity
Surgery-wound infection
|
3 Participants
|
0 Participants
|
|
Toxicity
Abdominal pain/cramping
|
1 Participants
|
1 Participants
|
|
Toxicity
Acidosis
|
0 Participants
|
1 Participants
|
|
Toxicity
Acute vascular leak syndrome
|
0 Participants
|
1 Participants
|
|
Toxicity
Alkaline phosphatase increase
|
0 Participants
|
3 Participants
|
|
Toxicity
Allergic reaction
|
1 Participants
|
0 Participants
|
|
Toxicity
Anal incontinence
|
0 Participants
|
1 Participants
|
|
Toxicity
Anemia
|
0 Participants
|
8 Participants
|
|
Toxicity
Anorexia
|
1 Participants
|
9 Participants
|
|
Toxicity
Anxiety/agitation
|
4 Participants
|
5 Participants
|
|
Toxicity
Apnea
|
1 Participants
|
0 Participants
|
|
Toxicity
Arrhythmia, NOS
|
2 Participants
|
0 Participants
|
|
Toxicity
Arthralgia
|
4 Participants
|
3 Participants
|
|
Toxicity
Bilirubin increase
|
0 Participants
|
1 Participants
|
|
Toxicity
Bone pain
|
0 Participants
|
4 Participants
|
|
Toxicity
CPK increase
|
0 Participants
|
1 Participants
|
|
Toxicity
Cardiovascular-other
|
1 Participants
|
0 Participants
|
|
Toxicity
Catheter related infection
|
0 Participants
|
2 Participants
|
|
Toxicity
Cerebrovascular ischemia
|
1 Participants
|
0 Participants
|
|
Toxicity
Colitis
|
0 Participants
|
2 Participants
|
|
Toxicity
Confusion
|
2 Participants
|
3 Participants
|
|
Toxicity
Constipation/bowel obstruction
|
0 Participants
|
4 Participants
|
|
Toxicity
Cranial neuropathy
|
1 Participants
|
0 Participants
|
|
Toxicity
Creatinine increase
|
0 Participants
|
4 Participants
|
|
Toxicity
Dehydration
|
1 Participants
|
7 Participants
|
|
Toxicity
Delusions
|
0 Participants
|
1 Participants
|
|
Toxicity
Depression
|
14 Participants
|
4 Participants
|
|
Toxicity
Diarrhea without colostomy
|
2 Participants
|
6 Participants
|
|
Toxicity
Dizziness/light headedness
|
2 Participants
|
1 Participants
|
|
Toxicity
Dizziness/vertigo, NOS
|
0 Participants
|
1 Participants
|
|
Toxicity
Double vision
|
0 Participants
|
1 Participants
|
|
Toxicity
Dyspnea
|
1 Participants
|
2 Participants
|
|
Toxicity
Eryth/rash/eruption/desq, NOS
|
1 Participants
|
3 Participants
|
|
Toxicity
Esophagitis/dysphagia
|
0 Participants
|
2 Participants
|
|
Toxicity
Eye-other
|
1 Participants
|
0 Participants
|
|
Toxicity
Fatigue/malaise/lethargy
|
38 Participants
|
22 Participants
|
|
Toxicity
Febrile neutropenia
|
1 Participants
|
9 Participants
|
|
Toxicity
Fever without neutropenia
|
1 Participants
|
5 Participants
|
|
Toxicity
Fever, NOS
|
0 Participants
|
1 Participants
|
|
Toxicity
Hallucinations
|
1 Participants
|
1 Participants
|
|
Toxicity
Headache
|
9 Participants
|
5 Participants
|
|
Toxicity
Hemorrhage w/ 3-4 thrombocyt
|
0 Participants
|
1 Participants
|
|
Toxicity
Hyperglycemia
|
2 Participants
|
3 Participants
|
|
Toxicity
Hyperkalemia
|
0 Participants
|
1 Participants
|
|
Toxicity
Hypermagnesemia
|
1 Participants
|
1 Participants
|
|
Toxicity
Hypertension
|
0 Participants
|
1 Participants
|
|
Toxicity
Hypertriglyceridemia
|
1 Participants
|
0 Participants
|
|
Toxicity
Hypocalcemia
|
0 Participants
|
18 Participants
|
|
Toxicity
Hypokalemia
|
1 Participants
|
7 Participants
|
|
Toxicity
Hypomagnesemia
|
0 Participants
|
5 Participants
|
|
Toxicity
Hyponatremia
|
0 Participants
|
6 Participants
|
|
Toxicity
Hypophosphatemia
|
0 Participants
|
4 Participants
|
|
Toxicity
Hypotension
|
0 Participants
|
16 Participants
|
|
Toxicity
Hypoxia
|
0 Participants
|
1 Participants
|
|
Toxicity
Infection w/o 3-4 neutropenia
|
0 Participants
|
3 Participants
|
|
Toxicity
Infection with 3-4 neutropenia
|
0 Participants
|
9 Participants
|
|
Toxicity
Infection, unk ANC
|
1 Participants
|
2 Participants
|
|
Toxicity
Insomnia
|
1 Participants
|
1 Participants
|
|
Toxicity
Leukopenia
|
12 Participants
|
38 Participants
|
|
Toxicity
Lipase increase
|
1 Participants
|
2 Participants
|
|
Toxicity
Local injection site reaction
|
1 Participants
|
0 Participants
|
|
Toxicity
Lymphopenia
|
0 Participants
|
2 Participants
|
|
Toxicity
Mood/consciousness change, NOS
|
0 Participants
|
1 Participants
|
|
Toxicity
Muscle weakness (not neuro)
|
0 Participants
|
1 Participants
|
|
Toxicity
Myalgia
|
7 Participants
|
4 Participants
|
|
Toxicity
Nausea
|
10 Participants
|
51 Participants
|
|
Toxicity
Neutropenia/granulocytopenia
|
25 Participants
|
61 Participants
|
|
Toxicity
PRBC transfusion
|
0 Participants
|
3 Participants
|
|
Toxicity
Pancreatitis
|
0 Participants
|
1 Participants
|
|
Toxicity
Syncope
|
2 Participants
|
0 Participants
|
|
Toxicity
Thrombocytopenia
|
1 Participants
|
50 Participants
|
|
Toxicity
Thrombosis/embolism
|
1 Participants
|
1 Participants
|
|
Toxicity
Typhlitis
|
0 Participants
|
1 Participants
|
|
Toxicity
Vertigo
|
1 Participants
|
0 Participants
|
|
Toxicity
Vomiting
|
9 Participants
|
37 Participants
|
|
Toxicity
Weakness (motor neuropathy)
|
1 Participants
|
2 Participants
|
|
Toxicity
Weight loss
|
3 Participants
|
0 Participants
|
Adverse Events
Interferon
Serious events: 2 serious events
Other events: 132 other events
Deaths: 0 deaths
Biochemotherapy
Serious events: 4 serious events
Other events: 144 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interferon
n=193 participants at risk
interferon alfa
|
Biochemotherapy
n=185 participants at risk
cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
|
|---|---|---|
|
Blood and lymphatic system disorders
Platelet transfusion
|
0.00%
0/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.54%
1/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.54%
1/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Reportable adverse event, NOS
|
0.52%
1/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Infections and infestations
Respiratory infect w/ neutrop
|
0.00%
0/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.54%
1/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Nervous system disorders
Cerebrovascular ischemia
|
0.52%
1/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Psychiatric disorders
Depression
|
0.00%
0/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.54%
1/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
Other adverse events
| Measure |
Interferon
n=193 participants at risk
interferon alfa
|
Biochemotherapy
n=185 participants at risk
cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
7.8%
15/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
14.6%
27/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Diarrhea without colostomy
|
6.7%
13/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Nausea
|
19.2%
37/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
36.2%
67/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
23/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
28.1%
52/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Fatigue/malaise/lethargy
|
40.9%
79/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
14.6%
27/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Fever without neutropenia
|
11.9%
23/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
13.0%
24/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
General disorders
Rigors/chills
|
14.0%
27/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Alkaline phosphatase increase
|
0.00%
0/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
8.6%
16/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Creatinine increase
|
0.00%
0/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
7.0%
13/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Leukopenia
|
15.5%
30/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
22.7%
42/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Neutropenia/granulocytopenia
|
19.7%
38/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
35.1%
65/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
SGOT (AST) increase
|
21.8%
42/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
10.8%
20/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
SGPT (ALT) increase
|
27.5%
53/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
10.8%
20/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Thrombocytopenia
|
7.8%
15/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
31.4%
58/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Investigations
Weight loss
|
6.2%
12/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.9%
11/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
18.9%
35/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
9.7%
18/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
12/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.9%
23/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
7.6%
14/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Nervous system disorders
Headache
|
8.8%
17/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Psychiatric disorders
Anxiety/agitation
|
6.2%
12/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.4%
10/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Psychiatric disorders
Depression
|
16.1%
31/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
0.00%
0/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
5.9%
11/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
|
Vascular disorders
Hypotension
|
0.00%
0/193 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
11.9%
22/185 • While the patient is on treatment until resolution of acute toxicities with maximum grade reported
Regular investigator assessments are reported after each cycle of protocol treatment
|
Additional Information
SWOG Melanoma Statistician
SWOG statistical office
Phone: 206-667-4408
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place