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NCT01826864
Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma
Phase 3 trial testing sargramostim in Stage IB Melanoma. Withdrawn.
8 August 2017
Quick facts
| Lead sponsor | Jonsson Comprehensive Cancer Center |
|---|---|
| Phase | Phase 3 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 5 August 2011 |
| Primary completion | 8 August 2017 |
| Estimated completion | 8 August 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- sargramostim (SARGRAMOSTIM) — full drug profile →
- sentinel lymph node biopsy
- laboratory biomarker analysis — full drug profile →
- hypertonic saline — full drug profile →
Conditions studied
- Stage IB Melanoma — all drugs for Stage IB Melanoma →
- Stage IIA Melanoma — all drugs for Stage IIA Melanoma →
- Stage IIB Melanoma — all drugs for Stage IIB Melanoma →
- Stage IIC Melanoma — all drugs for Stage IIC Melanoma →
Sponsor
Jonsson Comprehensive Cancer Center — full company profile →
Who can join
Adults 18 to 75, any sex, with Stage IB Melanoma or Stage IIA Melanoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This randomized phase III trial studies sargramostim before sentinel lymph node biopsy to see how well it works compared to hypertonic saline before sentinel lymph node biopsy in treating patients with melanoma. Biological therapies, such as sargramostim, may stimulate the immune system in different ways and stop cancer cells from growing. It is not yet known whether sargramostim is more effective than hypertonic saline in treating patients with stage IB-II melanoma undergoing sentinel lymph node biopsy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01826864
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Jonsson Comprehensive Cancer Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01826864 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center
- Last refreshed: 27 July 2020
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/NCT01826864.
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