MelanomaMEL37NCT00912418
Pilot Study for the Evaluation of the Efficacy of Vaccination With Autologous Tumor Cells Plus Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) - in - Adjuvant, Followed by Systemic Low-dose-interleukin-2 (IL-2) Administration, in Patients With High Risk Melanoma
A study testing autologous tumor cells plus GM-CSF-in Adjuvant in people with Melanoma, run by Craig L Slingluff, Jr at 1 site in United States.
Trial summary
This study is an open-label, pilot study of an autologous tumor cell vaccine. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Melanoma
- What is being tested?
- autologous tumor cells plus GM-CSF-in Adjuvant
- Type of treatment
- Vaccines
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2000to 9 Oct 2002
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have been diagnosed, by cytologic or histologic examination, with stage III or stage IV melanoma, where sufficient resected tumor is available for vaccine preparation (approximately 3 g tumor).
- Measurable tumor after resection is not required.
- Patients with up to 3 brain metastases may be included if the metastases are all < 2 cm in diameter, are asymptomatic, and there is no mass effect or they have been treated successfully by surgical excision or by gamma knife radiation therapy.
- Patients who have had a larger number of brain metastases resected or treated and resolved after gamma knife radiation therapy may be included if their status at the time of study initiation meets these criteria.
- For those patients with resected melanoma, surgical resections must have been performed within 6 months prior to entry. All patients must have:
- ECOG performance status 0-1, and, ability and willingness to give informed consent.
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- Laboratory parameters as follows: ANC > 1000/mm3, and Platelets > 100,000 and Hgb > 10.
- Hepatic: AST and ALT up to 1.5 x upper limits of normal (ULN), Bilirubin within ULN, Alkaline phosphatase up to 1.5 x ULN
- Renal: Creatinine within ULN
- Serology: HIV negative, Hepatitis C virus-negative.
- Patients who are not candidates for interferon, for people who decide not to take interferon, or for people who have failed interferon therapy (those patients who have progressed while on interferon therapy or who experienced a major toxicity while receiving treatment).
Who cannot join
- Patients who are currently receiving cytotoxic chemotherapy or radiation therapy, or who have received that therapy within the preceding 4 weeks.
- Patients who are currently receiving investigational agents, or who have received investigational agents within the preceding 30 days.
- Patients with known or suspected allergies to any component of the vaccine.
- Patients receiving the following medications at study entry or within 30 days are excluded:
- Allergy desensitization injections
- Corticosteroids, administered parenterally or orally.
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- Topical corticosteroids are acceptable, Any growth factors, Interferons, Interleukin 2 (IL-2).
- Prior melanoma vaccinations will not be an exclusion criteria if given more than 8 weeks previously, but will be recorded, and data analysis will take this into account.
- Other investigational drugs or investigational therapy also will not necessarily be an exclusion criteria, but will similarly be recorded and taken into account during data analysis.
- Pregnancy or the possibility of becoming pregnant during vaccine administration.
- Female patients of child-bearing potential must have a negative pregnancy test (urinary or serum beta-HCG) prior to administration of the first vaccine dose.
- Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination. This is consistent with existing standards of practice for vaccine and chemotherapy protocols.
- Patients in whom there is a medical contraindication or other potential medical problem in complying with the requirements of the protocol, in the opinion of the investigator.
- Patients classified according to the New York Heart Association classification system as having Class II, III or IV heart disease.
- Patients with active connective tissue disease requiring medications, or other severe autoimmune disease.
- Patients who are actively hyperthyroid.
- Patients with uncontrolled diabetes.
- Patients with known allergies to penicillin, streptomycin, and amphotericin B.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22908
About this study
Official title: Pilot Study for the Evaluation of the Efficacy of Vaccination With Autologous Tumor Cells Plus GM-CSF-in-adjuvant, Followed by Systemic Low-dose-IL-2 Administration, in Patients With High Risk Melanoma.
This study is an open-label, pilot study of an autologous tumor cell vaccine.
Read the detailed description
Regimen: A vaccine comprising autologous melanoma cells plus GM-CSF in-adjuvant will be administered intradermally at a single dose. Subjects will be vaccinated over at least a 6 week period (at weeks 0, 1, 2, 4, 5, 6), with responders vaccinated every 4 weeks thereafter for a maximum of 9 vaccinations (up to week 18). Systemic low-dose interleukin-2 will also be administered daily for 6 weeks following the second vaccination at week 1.
Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 vaccinations in a different site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods.
- Conditions
- Melanoma
- Being tested
- autologous tumor cells plus GM-CSF-in Adjuvant
- Keywords
- melanoma, vaccine, IL2 low dose
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous tumor cells plus GM-CSF-in AdjuvantBiological
Autologous tumor cells plus 225 ug GM-CSF in-adjuvant: The autologous tumor cells will be administered intradermally. Subjects will be vaccinated over at least a 6 week period (at weeks 0, 1, 2, 4, 5, 6), with responders vaccinated every 4 weeks thereafter for a maximum of 9 vaccinations (up to week 18). Systemic low-dose interleukin-2 will also be administered daily for 6 weeks following the second vaccination at week 1.
Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 vaccinations in a different site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytotoxic T-cell response to autologous tumor (as measured by staining assay)
Secondary outcomes (1)
Cytotoxic T-cell response to defined melanoma antigens. 1: Activation antigen expression by lymph node T-cells 2: Delayed-type hypersensitivity response to autologous tumor cells. 3: Antibody response to autologous tumor cells.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study start1 May 2000
- Primary completion17 Sep 2002
- Study completion9 Oct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig L Slingluff, Jr
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Craig L Slingluff, Jr, University of Virginia
- Investigators
- Craig L Slingluff, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00912418
- Sponsor's protocol ID
- 8577
- Acronym
- MEL37
- Status last verified
- Feb 2020
- First submitted
- 1 Jun 2009
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for the Evaluation of the Efficacy of Vaccination With Autologous Tumor Cells Plus GM-CSF-in-adjuvant, Followed by Systemic Low-dose-IL-2 Administration, in Patients With High Risk Melanoma.
- ClinicalTrials.gov ID
- NCT00912418
- Acronym / sponsor ID
- MEL37 / 8577
- Conditions
- Melanoma
- Keywords
- melanoma, vaccine, IL2 low dose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Craig L Slingluff, JrUniversity, hospital or other
- Study start
- 1 May 2000 (actual)
- Primary completion
- 17 Sep 2002 (actual)
- Study completion
- 9 Oct 2002 (actual)
- First posted
- 3 Jun 2009 (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 study is an open-label, pilot study of an autologous tumor cell vaccine.
Detailed description
Regimen: A vaccine comprising autologous melanoma cells plus GM-CSF in-adjuvant will be administered intradermally at a single dose. Subjects will be vaccinated over at least a 6 week period (at weeks 0, 1, 2, 4, 5, 6), with responders vaccinated every 4 weeks thereafter for a maximum of 9 vaccinations (up to week 18). Systemic low-dose interleukin-2 will also be administered daily for 6 weeks following the second vaccination at week 1.
Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 vaccinations in a different site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients who have been diagnosed, by cytologic or histologic examination, with stage III or stage IV melanoma, where sufficient resected tumor is available for vaccine preparation (approximately 3 g tumor).
- Measurable tumor after resection is not required.
- Patients with up to 3 brain metastases may be included if the metastases are all < 2 cm in diameter, are asymptomatic, and there is no mass effect or they have been treated successfully by surgical excision or by gamma knife radiation therapy.
- Patients who have had a larger number of brain metastases resected or treated and resolved after gamma knife radiation therapy may be included if their status at the time of study initiation meets these criteria.
- For those patients with resected melanoma, surgical resections must have been performed within 6 months prior to entry. All patients must have:
Key exclusion criteria (18 listed)
- Patients who are currently receiving cytotoxic chemotherapy or radiation therapy, or who have received that therapy within the preceding 4 weeks.
- Patients who are currently receiving investigational agents, or who have received investigational agents within the preceding 30 days.
- Patients with known or suspected allergies to any component of the vaccine.
- Patients receiving the following medications at study entry or within 30 days are excluded:
- Topical corticosteroids are acceptable, Any growth factors, Interferons, Interleukin 2 (IL-2).
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 tumor cells plus GM-CSF-in AdjuvantAutologous tumor cells plus 225 ug GM-CSF in-adjuvant: The autologous tumor cells will be administered intradermally. Subjects will be vaccinated over at least a 6 week period (at weeks 0, 1, 2, 4, 5, 6), with responders vaccinated every 4 weeks thereafter for a maximum of 9 vaccinations (up to week 18). Systemic low-dose interleukin-2 will also be administered daily for 6 weeks following the second vaccination at week 1. Concurrent with the first three of these vaccinations, each patient will also receive an additional set of 3 vaccinations in a different site, the response to which will be evaluated at the draining lymph node. This node will be harvested using lymphatic mapping and sentinel node biopsy methods. | Biological | – |
Primary outcome
Cytotoxic T-cell response to autologous tumor (as measured by staining assay)
1 secondary outcome
Cytotoxic T-cell response to defined melanoma antigens. 1: Activation antigen expression by lymph node T-cells 2: Delayed-type hypersensitivity response to autologous tumor cells. 3: Antibody response to autologous tumor cells.
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 2 Mar 2020.
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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.
Craig L Slingluff, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autologous tumor cells plus GM-CSF-in Adjuvant in people with Melanoma, run by Craig L Slingluff, Jr 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 11 inclusion and 18 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 2 Mar 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.
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?
Cytotoxic T-cell response to autologous tumor (as measured by staining assay). 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 2 Mar 2020.