Trial · NCT00006237
S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
NCT00006237, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2012-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma. Trials, record NCT00006237. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00006237
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- S0008: Chemotherapy Plus Biological Therapy in Treating Patients With Melanoma
- NCT number
- NCT00006237
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 432 participants, actual
- Lead sponsor
- SWOG Cancer Research Network
- Conditions
- Melanoma (Skin)
- Interventions
- interleukin-2, filgrastim, interferon alfa, cisplatin, dacarbazine, vinblastine
- First posted
- 2003-01-27
- Last updated
- 2015-03-25
- Results first posted
- 2012-09-19
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 5-year Overall Survival | Every three months for a year, every six months for years 2-5, annual for years 5-10 | 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. |
| Primary | 5-year Relapse-Free Survival | Every three months for the first year, every 6 months for years 2-5, annually for years 6-10 | Measured from date of registration to date of first observation of progressive disease or death due to any cause. |
| Secondary | Toxicity | 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. | Number of patients with Grade 3-5 adverse events that are related to study drug by given type of adverse event |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 5-year Overall Survival | Every three months for a year, every six months for years 2-5, annual for years 5-10 | Percent of population | NUMBER | |
| PRIMARY | 5-year Relapse-Free Survival | Every three months for the first year, every 6 months for years 2-5, annually for years 6-10 | Percentage of population | NUMBER | |
| SECONDARY | Toxicity | 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. | Eligible patients who started therapy | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group186
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 5-year Overall Survival | Interferon | 56 | Percent of population | ||
| 5-year Overall Survival | Biochemotherapy | 56 | Percent of population | ||
| 5-year Relapse-Free Survival | Interferon | 47 | Percentage of population | ||
| 5-year Relapse-Free Survival | Biochemotherapy | 38 | Percentage of population | ||
| Toxicity | Interferon | Abdominal pain/cramping | 1 | Participants | |
| Toxicity | Biochemotherapy | Abdominal pain/cramping | 1 | Participants | |
| Toxicity | Interferon | Acidosis | 0 | Participants | |
| Toxicity | Biochemotherapy | Acidosis | 1 | Participants | |
| Toxicity | Interferon | Acute vascular leak syndrome | 0 | Participants | |
| Toxicity | Biochemotherapy | Acute vascular leak syndrome | 1 | Participants |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Interferon | 212 | |
| Overall Study | STARTED | Biochemotherapy | 220 | |
| Overall Study | Eligible | Interferon | 203 | |
| Overall Study | Eligible | Biochemotherapy | 200 | |
| Overall Study | Eligible and Treated | Interferon | 203 | |
| Overall Study | Eligible and Treated | Biochemotherapy | 199 | |
| Overall Study | COMPLETED | Interferon | 87 | |
| Overall Study | COMPLETED | Biochemotherapy | 159 | |
| Overall Study | NOT COMPLETED | Interferon | 125 | |
| Overall Study | NOT COMPLETED | Biochemotherapy | 61 |
Source ClinicalTrials.gov
Adverse events62
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Interferon | 15 | 193 | |
| other | Anemia | Blood and lymphatic system disorders | Biochemotherapy | 27 | 185 | |
| other | Diarrhea without colostomy | Gastrointestinal disorders | Interferon | 13 | 193 | |
| other | Diarrhea without colostomy | Gastrointestinal disorders | Biochemotherapy | 0 | 185 | |
| other | Nausea | Gastrointestinal disorders | Interferon | 37 | 193 | |
| other | Nausea | Gastrointestinal disorders | Biochemotherapy | 67 | 185 | |
| other | Vomiting | Gastrointestinal disorders | Interferon | 23 | 193 | |
| other | Vomiting | Gastrointestinal disorders | Biochemotherapy | 52 | 185 | |
| other | Fatigue/malaise/lethargy | General disorders | Interferon | 79 | 193 | |
| other | Fatigue/malaise/lethargy | General disorders | Biochemotherapy | 27 | 185 |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Interferon | ||
| Total, all-cause mortality | Biochemotherapy | ||
| Total, other adverse events | Interferon | 132 | 193 |
| Total, other adverse events | Biochemotherapy | 144 | 185 |
| Total, serious adverse events | Interferon | 2 | 193 |
| Total, serious adverse events | Biochemotherapy | 4 | 185 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25332243 | DERIVED |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA032102 | Southwest Oncology Group Treatment Grant | BLANKE, CHARLES D. | OREGON HEALTH & SCIENCE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2013 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Interferon vs Biochemotherapy: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00006237
GET https://conductscience.org/api/trials/v1/NCT00006237/results?page=2