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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

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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

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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.

ListOutcomeTime frameDescription
Primary5-year Overall SurvivalEvery 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.
Primary5-year Relapse-Free SurvivalEvery 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.
SecondaryToxicity
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

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY5-year Overall SurvivalEvery three months for a year, every six months for years 2-5, annual for years 5-10Percent of populationNUMBER
PRIMARY5-year Relapse-Free SurvivalEvery three months for the first year, every 6 months for years 2-5, annually for years 6-10Percentage of populationNUMBER
SECONDARYToxicity
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 therapyParticipantsNUMBER

Results by group186

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
5-year Overall SurvivalInterferon56Percent of population
5-year Overall SurvivalBiochemotherapy56Percent of population
5-year Relapse-Free SurvivalInterferon47Percentage of population
5-year Relapse-Free SurvivalBiochemotherapy38Percentage of population
ToxicityInterferonAbdominal pain/cramping1Participants
ToxicityBiochemotherapyAbdominal pain/cramping1Participants
ToxicityInterferonAcidosis0Participants
ToxicityBiochemotherapyAcidosis1Participants
ToxicityInterferonAcute vascular leak syndrome0Participants
ToxicityBiochemotherapyAcute vascular leak syndrome1Participants

Participant flow10

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDInterferon212
Overall StudySTARTEDBiochemotherapy220
Overall StudyEligibleInterferon203
Overall StudyEligibleBiochemotherapy200
Overall StudyEligible and TreatedInterferon203
Overall StudyEligible and TreatedBiochemotherapy199
Overall StudyCOMPLETEDInterferon87
Overall StudyCOMPLETEDBiochemotherapy159
Overall StudyNOT COMPLETEDInterferon125
Overall StudyNOT COMPLETEDBiochemotherapy61

Adverse events62

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAnemiaBlood and lymphatic system disordersInterferon15193
otherAnemiaBlood and lymphatic system disordersBiochemotherapy27185
otherDiarrhea without colostomyGastrointestinal disordersInterferon13193
otherDiarrhea without colostomyGastrointestinal disordersBiochemotherapy0185
otherNauseaGastrointestinal disordersInterferon37193
otherNauseaGastrointestinal disordersBiochemotherapy67185
otherVomitingGastrointestinal disordersInterferon23193
otherVomitingGastrointestinal disordersBiochemotherapy52185
otherFatigue/malaise/lethargyGeneral disordersInterferon79193
otherFatigue/malaise/lethargyGeneral disordersBiochemotherapy27185

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityInterferon
Total, all-cause mortalityBiochemotherapy
Total, other adverse eventsInterferon132193
Total, other adverse eventsBiochemotherapy144185
Total, serious adverse eventsInterferon2193
Total, serious adverse eventsBiochemotherapy4185

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
25332243DERIVED

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
U10CA032102Southwest Oncology Group Treatment GrantBLANKE, CHARLES D.OREGON HEALTH & SCIENCE UNIVERSITYNATIONAL CANCER INSTITUTE1985 to 2013

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Interferon vs Biochemotherapy: serious adverse events

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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