Malignant MelanomaPhase 2NCT00616564
Phase II Trial of (IL-2) With Priming and (GM-CSF) in Patients With Advanced Melanoma
A Phase 2 study testing GM-CSF in people with Malignant Melanoma, run by Mt. Sinai Medical Center, Miami at 2 sites in United States.
Trial summary
High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998. Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions discussed above. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- GM-CSF
- How many people
- 36 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2006to Sep 2009
- Phase
- Phase 2
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of melanoma with measurable disease
- Patients with stage IV or unresectable advanced melanoma
- Age at least 16 years.
- ECOG performance status of 0-1
- Life expectancy > 3 months
- Adequate major organ function to tolerate therapy, as defined by:
Show all 14Show fewer
- Total bilirubin 2.0 mg/dL.
- Creatinine 1.8 mg/dL.
- WBC 3,000/mm3.
- Platelet count 100,000/mm3.
- Patients 50 years of age with one or more cardiac risk factors must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation
- Left ventricular ejection fraction > 40%
- Women of childbearing age must agree to use barrier method birth control and demonstrate a negative pregnancy test prior to initiation of protocol therapy. Periodic negative urine pregnancy tests will also be required.
- Patients must give written informed consent
Who cannot join
- No prior HD- IL-2 for stage IV/unresectable advanced disease. Prior low dose IL-2 is allowed.
- No more than 2 prior chemotherapy regimens are allowed.
- No active CNS metastases. Treated CNS metastases without recurrence or progression for > 8 weeks are allowed.
- No concurrent use of systemic corticosteroids
- Pregnant and/or lactating are excluded
- No concurrent antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccines, or other experimental therapies.
- No treatment for melanoma within the previous 4 weeks.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
David Lawson, MD
Atlanta, Georgia, 30322
Jose Lutzky, MD
Miami Beach, Florida, 33140
About this study
Official title: Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma
High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998. Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions discussed above.
Read the detailed description
The primary objectives of this phase II multicenter trial are to:
Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population.
The secondary objectives are to:
Determine the freedom from progression (FFP). Measure the response rate (RR). Obtain immunological data from the use of this regimen in vivo (as separate project: Moffitt?).
The proposed study is a multicenter phase II trial of HD-IL-2 in combination with GM-CSF. GM-CSF will be started 7 days before day 1 of HD-IL-2 and will be continued for 4 weeks to day 28, encompassing two cycles of HD-IL2. The first 9 patients will be closely monitored for unexpected toxicity.
- Conditions
- Malignant Melanoma
- Being tested
- GM-CSF
- Keywords
- GM-CSF, Interleukin, IL-2, Sargrostim
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSFDrug
Concomitant Priming with GM-CSF
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective
Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population
Measured: one - two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startFeb 2006
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mt. Sinai Medical Center, Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Chiron Corporation
- Responsible party
- Principal investigator, Jose Lutzky, Mt. Sinai Medical Center, Miami
- Investigators
- Jose Lutzky, M.D., Study chair, Mount Sinai Medical Center Miami Beach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00616564
- Sponsor's protocol ID
- MEL0105
- Status last verified
- May 2012
- First submitted
- 4 Feb 2008
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Phase II Trial of High-Dose Interleukin (IL-2) With Priming and Concomitant Sargramostim (GM-CSF) in Patients With Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00616564
- Acronym / sponsor ID
- MEL0105
- Conditions
- Malignant Melanoma
- Keywords
- GM-CSF, Interleukin, IL-2, Sargrostim
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mt. Sinai Medical Center, MiamiUniversity, hospital or other
- Collaborators
- Bayer, Chiron Corporation
- Study start
- Feb 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 15 Feb 2008 (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.
High-dose IL-2 treatment for metastatic melanoma has been approved by the FDA in 1998. Studies of GM-CSF plus IL-2 have not addressed the approved dose and schedule. This protocol will study the combination of HD-IL2 and GM-CSF given the potential synergistic interactions discussed above.
Detailed description
The primary objectives of this phase II multicenter trial are to:
Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population.
The secondary objectives are to:
Determine the freedom from progression (FFP). Measure the response rate (RR). Obtain immunological data from the use of this regimen in vivo (as separate project: Moffitt?).
The proposed study is a multicenter phase II trial of HD-IL-2 in combination with GM-CSF. GM-CSF will be started 7 days before day 1 of HD-IL-2 and will be continued for 4 weeks to day 28, encompassing two cycles of HD-IL2. The first 9 patients will be closely monitored for unexpected toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed diagnosis of melanoma with measurable disease
- Patients with stage IV or unresectable advanced melanoma
- Age at least 16 years.
- ECOG performance status of 0-1
- Life expectancy > 3 months
Key exclusion criteria (7 listed)
- No prior HD- IL-2 for stage IV/unresectable advanced disease. Prior low dose IL-2 is allowed.
- No more than 2 prior chemotherapy regimens are allowed.
- No active CNS metastases. Treated CNS metastases without recurrence or progression for > 8 weeks are allowed.
- No concurrent use of systemic corticosteroids
- Pregnant and/or lactating are excluded
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 |
|---|---|---|
| GM-CSFConcomitant Priming with GM-CSF | Drug | – |
Primary outcome
Primary Objective
Time frame: one - two years
Determine the 1 and 2-year survival of patients treated according to protocol. Assess the safety and toxicity of this regimen in this patient population
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
Related trials for Malignant Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
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.
Jose Lutzky, M.D. study chair
Mount Sinai Medical Center Miami Beach
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GM-CSF in people with Malignant Melanoma, run by Mt. Sinai Medical Center, Miami at 2 sites 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 14 inclusion and 7 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: finished, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Objective (time frame: one - two years). 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 3 May 2012.