Who is sponsoring NCT01460875?

NCT01460875 is sponsored by William Carson.

What drugs are being tested in NCT01460875?

Interventions in NCT01460875: recombinant interferon alfa-2b, laboratory biomarker analysis.

What condition does NCT01460875 study?

NCT01460875 studies Stage IA Skin Melanoma, Stage IB Skin Melanoma, Stage IIA Skin Melanoma, Stage IIB Skin Melanoma, Stage IIC Skin Melanoma, Stage IIIA Skin Melanoma, Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma, Stage IV Skin Melanoma.

Is NCT01460875 still recruiting?

NCT01460875 is currently completed. Last updated 2 November 2018.

Are results published for NCT01460875?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-11-02 · How we verify

NCT01460875

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Recombinant Interferon Alfa-2b in Treating Patients With Melanoma

Completed NA Results posted Last updated 2 November 2018

What this trial tests

NA trial testing recombinant interferon alfa-2b in Stage IA Skin Melanoma in 34 participants. Completed in 5 January 2014.

Timeline

22 April 2008

Primary endpoint
5 January 2014

5 January 2014

Quick facts

Lead sponsor	William Carson
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	22 April 2008
Primary completion	5 January 2014
Estimated completion	5 January 2014
Sites	1 location across United States

Drugs / interventions tested

recombinant interferon alfa-2b — full drug profile →
laboratory biomarker analysis — full drug profile →

Conditions studied

Stage IA Skin Melanoma — all drugs for Stage IA Skin Melanoma →
Stage IB Skin Melanoma — all drugs for Stage IB Skin Melanoma →
Stage IIA Skin Melanoma — all drugs for Stage IIA Skin Melanoma →
Stage IIB Skin Melanoma — all drugs for Stage IIB Skin Melanoma →

Sponsor

William Carson

Who can join

12 and older, any sex, with Stage IA Skin Melanoma or Stage IB Skin Melanoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Level of Activated STAT1(Phospho-STAT1) Primary · up to 4 weeks

Mean and 95% confidence interval will be summarized for phospho-STAT1 at a lower dose and the standard dose. The phospho-STAT1 will also be compared between the dose levels.

Dose I (10 MU/m2)

Group	Value	95% CI
Treatment (Interferon Therapy)	5.96	0.31 – 19.1

Dose II (4 MU/m2)

Group	Value	95% CI
Treatment (Interferon Therapy)	4.80	0.11 – 21.17

Number of Patients With Adverse Events Secondary · up to 1 year

Determine the tolerability of adjuvant IFN-α-2b administered at an optimized dose in terms of the toxicities that are observed and the ability of patients to receive a full year of therapy.

Group	Value	95% CI
Treatment (Interferon Therapy)	15

Percentage of Patients With Correlation Between STAT1 Phosphorylation and Interferon Alfa Gene Regulation Secondary · Prior to treatment and 1 and 4 hours post therapy on day 1 every other week during the first 12 weeks, and then every 3 months

Levels of p-STAT1 in PBMCs were analyzed just prior to IFN-a-2b administration to determine levels that remained stable or increased over the course of dose reduction.

Group	Value	95% CI
Treatment (Interferon Therapy)	71

Effect of Dose-reduction on Expression of Interferon Alfa Stimulated Genes Secondary · 1 hour post therapy

Evaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 10MU/m2

SOCS1-1 hour post 10MU-

Group	Value	95% CI
Treatment (Interferon Therapy)	1.5	0.6 – 6.2

OAS1-1 hour post 10MU-

Group	Value	95% CI
Treatment (Interferon Therapy)	1.6	0.5 – 24.8

CXCL10-1 hour post 10MU

Group	Value	95% CI
Treatment (Interferon Therapy)	28.7	0.2 – 5128.0

CD69-1 hour post 10MU

Group	Value	95% CI
Treatment (Interferon Therapy)	1.3	0.4 – 12.1

Effect of Dose-reduction on Interferon Alfa Gene Expression Secondary · 1 hour post therapy

Evaluated using microarray analysis of patient PBMCs. Compared using the Wilcoxon signed rank test for the dose 4MU/m2

SOCS1-1 hour post 4MU

Group	Value	95% CI
Treatment (Interferon Therapy)	1.2	0.4 – 17.7

OAS1-1 hour post 4MU

Group	Value	95% CI
Treatment (Interferon Therapy)	1.6	0.5 – 5.1

CXCL10-1 hour post 4MU

Group	Value	95% CI
Treatment (Interferon Therapy)	6.0	0.0 – 386.4

CD69-1 hour post 4MU

Group	Value	95% CI
Treatment (Interferon Therapy)	1.3	0.4 – 2.1

Effect of Dose-reduction on Interferon Alfa Gene Expression Through Marker CD69 Secondary · 4 hours post therapy

Evaluated using microarray analysis of patient PBMCs. Compared between doses using the Wilcoxon signed rank test.

SOCS1- 4 hour post-10MU

Group	Value	95% CI
Treatment (Interferon Therapy)	1.5	0.6 – 6.2

OAS1-4 hour post -10MU

Group	Value	95% CI
Treatment (Interferon Therapy)	1.6	0.5 – 24.8

CXCL10-4 hour post- 10MU

Group	Value	95% CI
Treatment (Interferon Therapy)	28.7	0.2 – 5128.0

CD69-4 hour post- 10MU

Group	Value	95% CI
Treatment (Interferon Therapy)	1.3	0.4 – 12.1

Effect of Dose-reduction on Interferon Alfa Gene Expression at Dose Level 4MU Secondary · 4 hours post therapy

Evaluated using microarray analysis of patient PBMCs. Compared between doses using the Wilcoxon signed rank test.

SOCS1-4 hour post 4MU-

Group	Value	95% CI
Treatment (Interferon Therapy)	1.6	0.4 – 8.8

OAS1-4 hour post 4MU

Group	Value	95% CI
Treatment (Interferon Therapy)	3.9	0.4 – 19.1

CXCL10-4 hour post 4MU

Group	Value	95% CI
Treatment (Interferon Therapy)	112.9	0.0 – 2898.0

CD69-4 hour post 4MU

Group	Value	95% CI
Treatment (Interferon Therapy)	1.5	0.4 – 4.5

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment (Interferon Therapy)

Serious: 22/34 (65%)

Deaths: —

Serious adverse events (6 terms)

Reaction	System	Treatment (Interferon Ther…
Myelosuppression	Blood and lymphatic system disorders	—
Fatigue	General disorders	—
Electrolyte Abnormalities	Metabolism and nutrition disorders	—
Increased AST	Investigations	—
Neuropsychiatric Systems	Psychiatric disorders	—
Nausea	Gastrointestinal disorders	—

Other adverse events (13 terms — click to expand)

Reaction	System	Treatment (Interferon Ther…
Myalgia	Musculoskeletal and connective tissue disorders	—
Fatigue	General disorders	—
Mylosuppression	Blood and lymphatic system disorders	—
Electrolyte Abnormalities	Metabolism and nutrition disorders	—
Increased AST	Investigations	—
Rigors/Chills	General disorders	—
Nausea	Gastrointestinal disorders	—
Neuropsychiatric Symptoms	Psychiatric disorders	—
Hyperglycemia	Metabolism and nutrition disorders	—
Alopecia	Skin and subcutaneous tissue disorders	—
Diarrhea	Gastrointestinal disorders	—
Fever	General disorders	—
Vomiting	Gastrointestinal disorders	—

Most-reported serious reactions: Myelosuppression, Fatigue, Electrolyte Abnormalities, Increased AST, Neuropsychiatric Systems, Nausea.

Data from ClinicalTrials.gov NCT01460875 adverse events section.

Sponsor's own description

This pilot clinical trial studies recombinant interferon alfa-2b in treating patients with melanoma. Recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of melanoma

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Therapeutic modulators of STAT signalling for human diseases.
Miklossy G, Hilliard TS, Turkson J. · · 2013 · cited 343× · PMID 23903221 · DOI 10.1038/nrd4088
Type I Interferon (IFN)-Regulated Activation of Canonical and Non-Canonical Signaling Pathways.
Mazewski C, Perez RE, Fish EN, Platanias LC. · · 2020 · cited 159× · PMID 33329603 · DOI 10.3389/fimmu.2020.606456
A pilot study of interferon-alpha-2b dose reduction in the adjuvant therapy of high-risk melanoma.
Suarez-Kelly LP, Levine KM, Olencki TE, Del Campo SEM, et al · · 2019 · cited 7× · PMID 30725205 · DOI 10.1007/s00262-019-02308-w

Verify or expand the search:

Other trials of recombinant interferon alfa-2b

Trials testing the same drug.

NCT01100528 — Dacarbazine and Recombinant Interferon Alfa-2b in Treating Patients With Primary Uveal Melanoma With Genetic Imbalance · Phase 2 · completed

Other William Carson trials

Trials by the same sponsor.

NCT02013492 — Propranolol Hydrochloride in Treating Patients With Locally Recurrent or Metastatic Solid Tumors That Cannot Be Removed · EARLY_PHASE1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01460875 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by William Carson
Last refreshed: 2 November 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01460875.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing