Stage IB MelanomaPhase 3NCT01826864
Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma
A Phase 3 study testing sargramostim, sentinel lymph node biopsy and laboratory biomarker analysis in people with Stage IB Melanoma and Stage IIA Melanoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stage IB Melanoma, Stage IIA Melanoma, Stage IIB Melanoma
- What is being tested?
- sargramostim, sentinel lymph node biopsy and laboratory biomarker analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2011to 8 Aug 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with stage IB or II cutaneous melanoma
- Primaries on the torso, upper and lower extremities and head and neck region
- Skin biopsy performed at least 5 days and no longer than 10 weeks from the time of initial entry into the study
- Bilirubin < 2.0 ng/dl
- Creatinine < 3.0 ng/dl
- Able to understand the consent competent to sign
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Who cannot join
- Prior wide excision with diameter of the excision > 3 cm
- Primary melanoma arises from the eye or mucus membranes
- Clinical evidence of regional, intransit ,or distant metastases
- Second invasive melanoma
- Prior surgical procedures that would alter the drainage patterns and would prevent us from identifying sentinel lymph nodes (SN)
- Patients with primary or secondary immunodeficiencies
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- Pregnancy
- Known allergy to sargramostim (GM-CSF)
- History of cardiac disease, in particular, supraventricular tachycardia
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if the alterations in morphology and phenotype to the sentinel lymph nodes are reversible.
II. To determine if the restoration of the morphology or phenotype of sentinel lymph nodes results in diminished regional tumor burden.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sargramostim subcutaneously (SC) 3-5 days prior to undergoing sentinel lymph node biopsy.
ARM II: Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.
After completion of study treatment, patients are followed up for 30 days.
- Being tested
- sargramostim, sentinel lymph node biopsy, laboratory biomarker analysis, hypertonic saline
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sargramostimBiological
Also called GM-CSF, Leukine, Prokine
Given SC
sentinel lymph node biopsyProcedure or surgery
Also called sentinel node biopsy
Undergo sentinel lymph node biopsy
laboratory biomarker analysisOther
Correlative studies
hypertonic salineOther
Also called HTS
Given SC
| Study group | Role | What they receive |
|---|---|---|
| Arm I (sargramostim and sentinel lymph node biopsy) | Experimental | Patients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy. Receives: Biological: sargramostim; Procedure: sentinel lymph node biopsy; Other: laboratory biomarker analysis |
| Arm II (hypertonic saline and sentinel lymph node biopsy) | Active comparator | Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy. Receives: Procedure: sentinel lymph node biopsy; Other: laboratory biomarker analysis; Other: hypertonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of alterations in the SN
A series of analysis of variance (ANOVA) models will be employed.
Measured: Up to 30 days
Proportion of subjects with positive SN in each group
The primary analysis will be a two group continuity corrected Chi-squared test. A logistic regression analysis will also be run.
Measured: Up to 30 days
Secondary outcomes (2)
Disease free survival (DFS)
A two sample t-test will be used.
Measured: Up to 30 days
Overall survival (OS)
A two sample t-test will be used.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study start5 Aug 2011
- Primary completion8 Aug 2017
- Study completion8 Aug 2017
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IB MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard Essner, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826864
- Sponsor's protocol ID
- 11-002177
- Other IDs
- NCI-2013-00645, 5R01CA120228
- Status last verified
- Mar 2018
- First submitted
- 4 Apr 2013
- Last updated
- 27 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Trial to Compare the Immunodulatory Effects of Leukine vs. Saline for Early-stage Melanoma Patients Undergoing Sentinel Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT01826864
- Acronym / sponsor ID
- 11-002177
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Genzyme, a Sanofi Company, National Cancer Institute (NCI)
- Study start
- 5 Aug 2011 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 8 Aug 2017 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine if the alterations in morphology and phenotype to the sentinel lymph nodes are reversible.
II. To determine if the restoration of the morphology or phenotype of sentinel lymph nodes results in diminished regional tumor burden.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive sargramostim subcutaneously (SC) 3-5 days prior to undergoing sentinel lymph node biopsy.
ARM II: Patients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy.
After completion of study treatment, patients are followed up for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (sargramostim and sentinel lymph node biopsy) | Experimental | Biological: sargramostim, Procedure: sentinel lymph node biopsy, Other: laboratory biomarker analysisPatients receive sargramostim SC 3-5 days prior to undergoing sentinel lymph node biopsy. |
| Arm II (hypertonic saline and sentinel lymph node biopsy) | Active comparator | Procedure: sentinel lymph node biopsy, Other: laboratory biomarker analysis, Other: hypertonic salinePatients receive hypertonic saline SC 3-5 days prior to undergoing sentinel lymph node biopsy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with stage IB or II cutaneous melanoma
- Primaries on the torso, upper and lower extremities and head and neck region
- Skin biopsy performed at least 5 days and no longer than 10 weeks from the time of initial entry into the study
- Bilirubin < 2.0 ng/dl
- Creatinine < 3.0 ng/dl
Key exclusion criteria (9 listed)
- Prior wide excision with diameter of the excision > 3 cm
- Primary melanoma arises from the eye or mucus membranes
- Clinical evidence of regional, intransit ,or distant metastases
- Second invasive melanoma
- Prior surgical procedures that would alter the drainage patterns and would prevent us from identifying sentinel lymph nodes (SN)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sargramostimAlso: GM-CSF, Leukine, ProkineGiven SC | Biological | Arm I (sargramostim and sentinel lymph node biopsy) |
| sentinel lymph node biopsyAlso: sentinel node biopsyUndergo sentinel lymph node biopsy | Procedure or surgery | Arm I (sargramostim and sentinel lymph node biopsy), Arm II (hypertonic saline and sentinel lymph node biopsy) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (sargramostim and sentinel lymph node biopsy), Arm II (hypertonic saline and sentinel lymph node biopsy) |
| hypertonic salineAlso: HTSGiven SC | Other | Arm II (hypertonic saline and sentinel lymph node biopsy) |
Primary outcome
Reversal of alterations in the SN
Time frame: Up to 30 days
A series of analysis of variance (ANOVA) models will be employed.
Proportion of subjects with positive SN in each group
Time frame: Up to 30 days
The primary analysis will be a two group continuity corrected Chi-squared test. A logistic regression analysis will also be run.
2 secondary outcomes
Disease free survival (DFS)
Time frame: Up to 30 days
Overall survival (OS)
Time frame: Up to 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
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Melanoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Essner principal investigator
Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sargramostim, sentinel lymph node biopsy and laboratory biomarker analysis in people with Stage IB Melanoma and Stage IIA Melanoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal of alterations in the SN (time frame: Up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.