A Phase 3 interventional study of interleukin-2 and filgrastim in Melanoma (Skin), sponsored by SWOG Cancer Research Network. Completed at 297 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by SWOG Cancer Research Network · Phase 3, Interventional, and Treatment
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill melanoma cells. It is not yet known whether interferon alfa is more effective with or without combination chemotherapy and interleukin-2 for melanoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with or without combination chemotherapy consisting of cisplatin, vinblastine, and dacarbazine, plus interleukin-2, in treating patients who have melanoma.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (N1 or N2 vs N3), degree of lymph node involvement (micrometastases only vs any macrometastases, including satellite/in-transit metastases), and ulceration of the primary tumor (yes vs no vs unknown primary). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
PROJECTED ACCRUAL: A total of 410 patients (205 per treatment arm) will be accrued for this study within 3 years.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 432 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.
Browse Melanoma studies →SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically proven melanoma of cutaneous origin or from unknown primary at initial presentation of primary or first clinically detected nodal or satellite/in-transit recurrence
One of the following criteria must apply for patients with newly diagnosed melanoma OR a previously diagnosed primary with current subsequent, clinical, regional nodal disease and/or satellite/in-transit disease:
Non-ulcerated or unknown primary melanoma with one macro/clinically overt lymph node metastasis, including a single matted nodal mass
Patients must be disease free at time of enrollment based on the following surgical criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Normal cardiac stress test required if any of the following are present:
Pulmonary:
Other:
No other prior malignancy within the past 5 years except the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
No prior radiotherapy
Surgery:
Other:
Patients receive 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.
Biological: interferon alfa
Patients receive cisplatin IV over 30 minutes followed by vinblastine IV on days 1-4. Patients also receive dacarbazine IV over 1 hour on day 1, interleukin-2 IV over 96 hours on days 1-4, and interferon alfa SC on days 1-5, 8, 10, and 12. In addition, patients receive filgrastim (G-CSF) SC on days 6-15. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Biological: interleukin-2 · Biological: filgrastim · Biological: interferon alfa · Drug: cisplatin · Drug: dacarbazine · Drug: vinblastine
Given IV
Also known as: aldesleukin
Given subcutaneously
Given IV and subcutaneously
Given IV
Given IV
Given IV
5-year Overall Survival
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.
Time frame: Every three months for a year, every six months for years 2-5, annual for years 5-10
5-year Relapse-Free Survival
Measured from date of registration to date of first observation of progressive disease or death due to any cause.
Time frame: Every three months for the first year, every 6 months for years 2-5, annually for years 6-10
Toxicity
Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
Time frame: 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.
| Milestone | Interferon | Biochemotherapy |
|---|---|---|
| Started | 212 | 220 |
| Eligible | 203 | 200 |
| Eligible and treated | 203 | 199 |
| Completed | 87 | 159 |
| Not completed | 125 | 61 |
| Withdrew: Adverse event | 39 | 29 |
| Withdrew: Death | 1 | 0 |
| Withdrew: Refusal unrelated to adverse effects | 8 | 4 |
| Withdrew: Progression/relapse | 54 | 2 |
| Withdrew: Not eligible | 9 | 20 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Not protocol specified | 14 | 5 |
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.
| Percent of population | Interferon | Biochemotherapy |
|---|---|---|
| 5-year Overall Survival | 56 | 56 |
Measured from date of registration to date of first observation of progressive disease or death due to any cause.
| Percentage of population | Interferon | Biochemotherapy |
|---|---|---|
| 5-year Relapse-Free Survival | 47 | 38 |
Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event
| Participants | Interferon | Biochemotherapy |
|---|---|---|
| Abdominal pain/cramping | 1 | 1 |
| Acidosis | 0 | 1 |
| Acute vascular leak syndrome | 0 | 1 |
| Alkaline phosphatase increase | 0 | 3 |
| Allergic reaction | 1 | 0 |
| Anal incontinence | 0 | 1 |
| Anemia | 0 | 8 |
| Anorexia | 1 | 9 |
| Anxiety/agitation | 4 | 5 |
| Apnea | 1 | 0 |
| Arrhythmia, NOS | 2 | 0 |
| Arthralgia | 4 | 3 |
| Bilirubin increase | 0 | 1 |
| Bone pain | 0 | 4 |
| CPK increase | 0 | 1 |
| Cardiovascular-other | 1 | 0 |
| Catheter related infection | 0 | 2 |
| Cerebrovascular ischemia | 1 | 0 |
| Colitis | 0 | 2 |
| Confusion | 2 | 3 |
| Constipation/bowel obstruction | 0 | 4 |
| Cranial neuropathy | 1 | 0 |
| Creatinine increase | 0 | 4 |
| Dehydration | 1 | 7 |
| Delusions | 0 | 1 |
| Depression | 14 | 4 |
| Diarrhea without colostomy | 2 | 6 |
| Dizziness/light headedness | 2 | 1 |
| Dizziness/vertigo, NOS | 0 | 1 |
| Double vision | 0 | 1 |
| Dyspnea | 1 | 2 |
| Eryth/rash/eruption/desq, NOS | 1 | 3 |
| Esophagitis/dysphagia | 0 | 2 |
| Eye-other | 1 | 0 |
| Fatigue/malaise/lethargy | 38 | 22 |
| Febrile neutropenia | 1 | 9 |
| Fever without neutropenia | 1 | 5 |
| Fever, NOS | 0 | 1 |
| Hallucinations | 1 | 1 |
| Headache | 9 | 5 |
| Hemorrhage w/ 3-4 thrombocyt | 0 | 1 |
| Hyperglycemia | 2 | 3 |
| Hyperkalemia | 0 | 1 |
| Hypermagnesemia | 1 | 1 |
| Hypertension | 0 | 1 |
| Hypertriglyceridemia | 1 | 0 |
| Hypocalcemia | 0 | 18 |
| Hypokalemia | 1 | 7 |
| Hypomagnesemia | 0 | 5 |
| Hyponatremia | 0 | 6 |
| Hypophosphatemia | 0 | 4 |
| Hypotension | 0 | 16 |
| Hypoxia | 0 | 1 |
| Infection w/o 3-4 neutropenia | 0 | 3 |
| Infection with 3-4 neutropenia | 0 | 9 |
| Infection, unk ANC | 1 | 2 |
| Insomnia | 1 | 1 |
| Leukopenia | 12 | 38 |
| Lipase increase | 1 | 2 |
| Local injection site reaction | 1 | 0 |
| Lymphopenia | 0 | 2 |
| Mood/consciousness change, NOS | 0 | 1 |
| Muscle weakness (not neuro) | 0 | 1 |
| Myalgia | 7 | 4 |
| Nausea | 10 | 51 |
| Neutropenia/granulocytopenia | 25 | 61 |
| PRBC transfusion | 0 | 3 |
| Pancreatitis | 0 | 1 |
| Personality/behavioral change | 1 | 0 |
| Petechiae/purpura | 0 | 1 |
| Platelet transfusion | 0 | 5 |
| Pruritus | 1 | 3 |
| Rash/desquamation | 4 | 10 |
| Renal failure | 0 | 1 |
| Reportable adverse event, NOS | 1 | 1 |
| Respiratory infect w/ neutrop | 0 | 2 |
| Rigors/chills | 2 | 1 |
| SGOT (AST) increase | 18 | 7 |
| SGPT (ALT) increase | 32 | 8 |
| Seizures | 0 | 2 |
| Sensory neuropathy | 0 | 2 |
| Stomatitis/pharyngitis | 0 | 1 |
| Surgery-wound infection | 3 | 0 |
| Syncope | 2 | 0 |
| Thrombocytopenia | 1 | 50 |
| Thrombosis/embolism | 1 | 1 |
| Typhlitis | 0 | 1 |
| Vertigo | 1 | 0 |
| Vomiting | 9 | 37 |
| Weakness (motor neuropathy) | 1 | 2 |
| Weight loss | 3 | 0 |
Collected over While the patient is on treatment until resolution of acute toxicities with maximum grade reported. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Interferon | — | 2/193 (1%) | 132/193 (68.4%) |
| Biochemotherapy | — | 4/185 (2.2%) | 144/185 (77.8%) |
| Event | Interferon | Biochemotherapy |
|---|---|---|
| Platelet transfusionBlood and lymphatic system disorders | 0/193 | 1/185 |
| ColitisGastrointestinal disorders | 0/193 | 1/185 |
| Respiratory infect w/ neutropInfections and infestations | 0/193 | 1/185 |
| DepressionPsychiatric disorders | 0/193 | 1/185 |
| Reportable adverse event, NOSGeneral disorders | 1/193 | 0/185 |
| Cerebrovascular ischemiaNervous system disorders | 1/193 | 0/185 |
| Event | Interferon | Biochemotherapy |
|---|---|---|
| Fatigue/malaise/lethargyGeneral disorders | 79/193 | 27/185 |
| NauseaGastrointestinal disorders | 37/193 | 67/185 |
| Neutropenia/granulocytopeniaInvestigations | 38/193 | 65/185 |
| ThrombocytopeniaInvestigations | 15/193 | 58/185 |
| VomitingGastrointestinal disorders | 23/193 | 52/185 |
| SGPT (ALT) increaseInvestigations | 53/193 | 20/185 |
| LeukopeniaInvestigations | 30/193 | 42/185 |
| SGOT (AST) increaseInvestigations | 42/193 | 20/185 |
| HypocalcemiaMetabolism and nutrition disorders | 0/193 | 35/185 |
| DepressionPsychiatric disorders | 31/193 | 0/185 |
| Age, Continuous(years) | Interferon | Biochemotherapy | Total |
|---|---|---|---|
| Median | 47 (12 to 73) | 46 (10 to 74) | 47 (10 to 74) |
| Sex: Female, Male(Participants) | Interferon | Biochemotherapy | Total |
|---|---|---|---|
| Female | 62 | 58 | 120 |
| Male | 141 | 141 | 282 |
| Region of Enrollment(participants) | Interferon | Biochemotherapy | Total |
|---|---|---|---|
| United States | 203 | 199 | 402 |
Showing the first 100 of 297 sites across 2 countries.
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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