Metastatic Malignant MelanomaPhase 1NCT02350972
Inducing Systemic Immunity and Regressions in Metastatic Melanoma
A Phase 1 study testing Autologous cytokines in people with Metastatic Malignant Melanoma, run by NYU Langone Health.
Trial summary
In patients with multiple metastatic nodules of melanoma, the investigators evaluated whether autologous cytokines injected into cutaneous metastases would induce a systemic immune response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that had never been injected. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Metastatic Malignant Melanoma
- What is being tested?
- Autologous cytokines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- Jul 1978to May 2002
- Phase
- Phase 1
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple cutaneous or subcutaneous metastases of melanoma
Who cannot join
- Visceral metastases on admission.
- No current chemotherapy or immunotherapy.
- Note study performed between 1978 and 2002 before current therapies were available.
About this study
In patients with multiple metastatic nodules of melanoma, the investigators evaluated whether autologous cytokines injected into cutaneous metastases would induce a systemic immune response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that had never been injected. Such immune responses were observed, and often the never-injected metastasis regressed completely. 20% of patients remained free of disease for greater than 5 years.
Read the detailed description
Lymphocytic infiltrates were seen in never-injected nodules only after several weeks of injections elsewhere. No adverse events were seen. The tumor-infiltrating lymphocytes were able to kill autologous melanoma ex vivo. Some patients who experienced complete regressions of all metastases lived without disease for over 10 years.
- Conditions
- Metastatic Malignant Melanoma
- Being tested
- Autologous cytokines
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous cytokinesBiological
Also called cytokine/chemokine
Sterile autologous cytokines were injected weekly into multiple metastatic nodules while other nodules in the patient were never injected and were monitored for the development of dense lymphocytic infiltrates as evidence of an induced immune response.
| Study group | Role | What they receive |
|---|---|---|
| Autologous cytokiines | Experimental | Autologous cytokines obtained from patients' blood mononuclear cells injected in volumes of 0.1 ml Receives: Biological: Autologous cytokines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune responses as evidenced by lymphocytic infiltrates in never-injected nodules.
The biopsies were examined by a licensed pathologist for the presence of dense lymphocytic infiltrates.
Measured: Cutaneous nodules were biopsied by a surgeon afer 8 to 20 weeks of injections.
Secondary outcomes (1)
Complete regression of a metastasis
70 % of patients had at least one nodule regress. 40 % had all metastases completely regress for 5 to 20 years (median 60 months).
Measured: Complete regressions of all injected and never-injected metastases occurred in different pts after 13 weeks to 48 months of injections. Pts with progressive disease were switched to chemotherapy at any point in the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startJul 1978
- Primary completionMay 2002
- Study completionMay 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Malignant MelanomaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fred T. Valentine, NYU Langone Health
- Investigators
- Fred T. Valentine, M.D., Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350972
- Sponsor's protocol ID
- S-1300774
- Status last verified
- Jan 2015
- First submitted
- 14 Jan 2015
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inducing Systemic Immunity and Regressions in Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT02350972
- Acronym / sponsor ID
- S-1300774
- Conditions
- Metastatic Malignant Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jul 1978
- Primary completion
- May 2002 (actual)
- Study completion
- May 2002 (actual)
- First posted
- 30 Jan 2015 (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.
In patients with multiple metastatic nodules of melanoma, the investigators evaluated whether autologous cytokines injected into cutaneous metastases would induce a systemic immune response as evidenced by the accumulation of dense lymphocytic infiltrates in metastases that had never been injected. Such immune responses were observed, and often the never-injected metastasis regressed completely. 20% of patients remained free of disease for greater than 5 years.
Detailed description
Lymphocytic infiltrates were seen in never-injected nodules only after several weeks of injections elsewhere. No adverse events were seen. The tumor-infiltrating lymphocytes were able to kill autologous melanoma ex vivo. Some patients who experienced complete regressions of all metastases lived without disease for over 10 years.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous cytokiines | Experimental | Biological: Autologous cytokinesAutologous cytokines obtained from patients' blood mononuclear cells injected in volumes of 0.1 ml |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Multiple cutaneous or subcutaneous metastases of melanoma
Key exclusion criteria (3 listed)
- Visceral metastases on admission.
- No current chemotherapy or immunotherapy.
- Note study performed between 1978 and 2002 before current therapies were available.
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 |
|---|---|---|
| Autologous cytokinesAlso: cytokine/chemokineSterile autologous cytokines were injected weekly into multiple metastatic nodules while other nodules in the patient were never injected and were monitored for the development of dense lymphocytic infiltrates as evidence of an induced immune response. | Biological | Autologous cytokiines |
Primary outcome
Immune responses as evidenced by lymphocytic infiltrates in never-injected nodules.
Time frame: Cutaneous nodules were biopsied by a surgeon afer 8 to 20 weeks of injections.
The biopsies were examined by a licensed pathologist for the presence of dense lymphocytic infiltrates.
1 secondary outcome
Complete regression of a metastasis
Time frame: Complete regressions of all injected and never-injected metastases occurred in different pts after 13 weeks to 48 months of injections. Pts with progressive disease were switched to chemotherapy at any point in the study.
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 30 Jan 2015.
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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.
Fred T. Valentine, M.D. principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous cytokines in people with Metastatic Malignant Melanoma, run by NYU Langone Health.
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 1 inclusion and 3 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 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Immune responses as evidenced by lymphocytic infiltrates in never-injected nodules. (time frame: Cutaneous nodules were biopsied by a surgeon afer 8 to 20 weeks of injections.). 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 30 Jan 2015.