MelanomaEarly Phase 1NCT00580060
Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity
A Early Phase 1 study testing GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D) in people with Melanoma, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptide vaccine… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma
- What is being tested?
- GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Jun 2011
- Phase
- Early 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must have documented malignant melanoma, American Joint Commission on Cancer (AJCC) stage IIB, IIC, III or IV (54). Patients with resectable stage IIB, IIC and III disease must have undergone surgical resection before participating in this study.
- Patients with choroidal melanoma may participate if they fulfill one of the following criteria: Basal diameter > or = 16 mm; Height > or = 8 mm or involvement of ciliary body with tumor.
- For all patients, pathology slides must be reviewed by the Pathology Department of Memorial Sloan-Kettering Cancer Center for confirmation of melanoma diagnosis.
- Patients must be HLA-A2 positive.
- Patients must weigh at least 25 kg to be eligible. Patients must be able to read the consent form and give informed consent. Parent or legal guardians of patients who are minors will sign the informed consent form.
- Patients must have a Karnofsky performance status of at least 80.
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- LDH ≤ 2x upper limit of normal value; albumin ≥ 3.5 mg/dl. Creatinine ≤ 2mg/dl and AST ≤ 2- fold upper limit of normal.
- A CBC prior to vaccination with WBC ≥ 3000, platelets ≥ 100,000.
- A negative serum bHCG within 2 weeks of vaccination in women of childbearing age.
- Patients must be free of detectable brain metastases. (Brain MRI or CT pre-protocol)
Who cannot join
- Patients may not be receiving or have received chemotherapy, immunotherapy or radiation therapy within the previous 4 weeks or nitrosourea chemotherapy within the previous 6 weeks. Patients must be fully recovered from any previous therapy or surgery.
- Patients may not have been previously immunized with vaccines containing tyrosinase or gp100, or peptides derived from tyrosinase or gp100.
- Creatinine > 2mg/dl (or history of Creatinine > 2 mg/dl) and AST ≥ 2 fold upper limit of normal.
- Any medical condition or use of medication (e.g., active autoimmune disease, immunodeficiency or corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators. Patients may not have taken systemic corticosteroids (orally or intravenously) within the previous 6 weeks. Inhaled or nasal steroids are permitted.
- Patients who have preexisting retinal or choroidal eye disease (except as outlined in section 5.1.1) will be excluded.
- Patients with serious underlying medical conditions, active infections requiring antimicrobial drugs, or active bleeding will be ineligible.
- Pregnant women, women who are less than 3 months post-partum or women who are nursing are not eligible. Women of childbearing age and sexually active men must be using appropriate contraception during the course of this study and for 3 months following completion.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA is safe and generates an immune response to peptides derived from antigens on melanoma cells.
Read the detailed description
This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA is safe and generates an immune response to peptides derived from antigens on melanoma cells.
In the Dose Ranging part of the study, cohorts of 3 patients will be treated at increasing dose levels of GM-CSF DNA delivered subcutaneously (100, 400, or 800 ug), followed by administration of both peptides subcutaneously to the same site on day 5 or day 6. Patients will be treated monthly for three immunizations. Pharmacokinetic studies will be performed during the first cycle. Patients' peripheral blood mononuclear cells will be collected in order to measure the T cell responses induced by the vaccines. Toxicity will be assessed during this part of the study, although we do not expect to achieve a dose limiting toxicity (DLT). The dose for the second part of the study will be the maximum tolerated dose.
The second part of the study will assess the immunological efficacy of the vaccine. Nine patients will receive GM-CSF DNA delivered subcutaneously at one site, followed by administration of both peptides to the same site on day 5 or day 6, every month for three immunizations. A total of at least 18 patients is planned for both phases of the study. Patients' peripheral blood mononuclear cells will be collected in order to measure the T cell responses induced by the vaccines. Specifically, Elispot assays for CD8+ T cells responses against the peptides will be assessed, and will be the primary method to determine the generation of a specific immune response to the peptide antigens.
- Conditions
- Melanoma
- Being tested
- GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)
- Keywords
- AJCC, stage, IIB, IIC, III, IV, Melanoma, HLA-A2+, Vaccine
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)Biological
Also called GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)
In the Dose Ranging part of the study, cohorts of 3 patients will be treated at increasing dose levels of GM-CSF DNA delivered subcutaneously (100, 400, or 800 mg), followed by administration of both peptides subcutaneously to the same site on day 5 or day 6. Patients will be treated monthly for three immunizations.
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the safety and a recommended dose of subcutaneous human GM-CSF DNA given in conjunction with a multi-epitope peptide vaccine in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+.
Measured: Up to 15 years post treatment,
To evaluate serum pharmacokinetics of GM-CSF after subcutaneous administration of human GM-CSF DNA.
Measured: All patients entered in the Dose Ranging study will undergo pharmacokinetic studies during their first course of therapy.
If toxicities are encountered in the dose ranging part of the study, to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT).
Measured: If toxicities less than DLT are encountered, then patients will continue on the study at the assigned dose level.
In the immunological efficacy study, to evaluate the immunogenicity of a multi-epitope peptide vaccine.
Measured: Up to 15 years post treatment.
Secondary outcomes (1)
A secondary endpoint is to observe the patients for evidence of any anti-tumor response that is generated after vaccination.
Measured: Up to 15 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2007 (estimated)
- Study startDec 2003
- Primary completionJun 2011
- Study completionJun 2011
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.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Miguel-Angel Perales, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580060
- Sponsor's protocol ID
- 00-142
- Other IDs
- NCI Protocol #: 5906
- Status last verified
- Jun 2011
- First submitted
- 20 Dec 2007
- Last updated
- 10 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Of AJCC Stage IIB, IIC, III And IV Melanoma Patients With A Multi-Epitope Peptide Vaccine Using GM-CSF DNA As An Adjuvant: A Pilot Trial To Assess Safety And Immunity
- ClinicalTrials.gov ID
- NCT00580060
- Acronym / sponsor ID
- 00-142
- Conditions
- Melanoma
- Keywords
- AJCC, stage, IIB, IIC, III, IV, Melanoma, HLA-A2+
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2003
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Dec 2007 (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 is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA is safe and generates an immune response to peptides derived from antigens on melanoma cells.
Detailed description
This is a pilot trial to investigate the use of GM-CSF DNA as an adjuvant for peptide vaccination in patients with metastatic melanoma. The objective of this study is to determine the safety and adjuvant effect of vaccination with the gene coding for human GM-CSF with a multi-epitope melanoma peptide vaccine (tyrosinase and gp100 peptides) in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+. We will assess whether use of GM-CSF DNA is safe and generates an immune response to peptides derived from antigens on melanoma cells.
In the Dose Ranging part of the study, cohorts of 3 patients will be treated at increasing dose levels of GM-CSF DNA delivered subcutaneously (100, 400, or 800 ug), followed by administration of both peptides subcutaneously to the same site on day 5 or day 6. Patients will be treated monthly for three immunizations. Pharmacokinetic studies will be performed during the first cycle. Patients' peripheral blood mononuclear cells will be collected in order to measure the T cell responses induced by the vaccines. Toxicity will be assessed during this part of the study, although we do not expect to achieve a dose limiting toxicity (DLT). The dose for the second part of the study will be the maximum tolerated dose.
The second part of the study will assess the immunological efficacy of the vaccine. Nine patients will receive GM-CSF DNA delivered subcutaneously at one site, followed by administration of both peptides to the same site on day 5 or day 6, every month for three immunizations. A total of at least 18 patients is planned for both phases of the study. Patients' peripheral blood mononuclear cells will be collected in order to measure the T cell responses induced by the vaccines. Specifically, Elispot assays for CD8+ T cells responses against the peptides will be assessed, and will be the primary method to determine the generation of a specific immune response to the peptide antigens.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have documented malignant melanoma, American Joint Commission on Cancer (AJCC) stage IIB, IIC, III or IV (54). Patients with resectable stage IIB, IIC and III disease must have undergone surgical resection before participating in this study.
- Patients with choroidal melanoma may participate if they fulfill one of the following criteria: Basal diameter > or = 16 mm; Height > or = 8 mm or involvement of ciliary body with tumor.
- For all patients, pathology slides must be reviewed by the Pathology Department of Memorial Sloan-Kettering Cancer Center for confirmation of melanoma diagnosis.
- Patients must be HLA-A2 positive.
- Patients must weigh at least 25 kg to be eligible. Patients must be able to read the consent form and give informed consent. Parent or legal guardians of patients who are minors will sign the informed consent form.
Key exclusion criteria (7 listed)
- Patients may not be receiving or have received chemotherapy, immunotherapy or radiation therapy within the previous 4 weeks or nitrosourea chemotherapy within the previous 6 weeks. Patients must be fully recovered from any previous therapy or surgery.
- Patients may not have been previously immunized with vaccines containing tyrosinase or gp100, or peptides derived from tyrosinase or gp100.
- Creatinine > 2mg/dl (or history of Creatinine > 2 mg/dl) and AST ≥ 2 fold upper limit of normal.
- Any medical condition or use of medication (e.g., active autoimmune disease, immunodeficiency or corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to respond immunologically to vaccines is grounds for exclusion, at the discretion of the Principal Investigator or co-Principal Investigators. Patients may not have taken systemic corticosteroids (orally or intravenously) within the previous 6 weeks. Inhaled or nasal steroids are permitted.
- Patients who have preexisting retinal or choroidal eye disease (except as outlined in section 5.1.1) will be 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-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)Also: GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D)In the Dose Ranging part of the study, cohorts of 3 patients will be treated at increasing dose levels of GM-CSF DNA delivered subcutaneously (100, 400, or 800 mg), followed by administration of both peptides subcutaneously to the same site on day 5 or day 6. Patients will be treated monthly for three immunizations. | Biological | – |
Primary outcome
To establish the safety and a recommended dose of subcutaneous human GM-CSF DNA given in conjunction with a multi-epitope peptide vaccine in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+.
Time frame: Up to 15 years post treatment,
To evaluate serum pharmacokinetics of GM-CSF after subcutaneous administration of human GM-CSF DNA.
Time frame: All patients entered in the Dose Ranging study will undergo pharmacokinetic studies during their first course of therapy.
If toxicities are encountered in the dose ranging part of the study, to establish the maximum tolerated dose (MTD) and dose limiting toxicities (DLT).
Time frame: If toxicities less than DLT are encountered, then patients will continue on the study at the assigned dose level.
In the immunological efficacy study, to evaluate the immunogenicity of a multi-epitope peptide vaccine.
Time frame: Up to 15 years post treatment.
1 secondary outcome
A secondary endpoint is to observe the patients for evidence of any anti-tumor response that is generated after vaccination.
Time frame: Up to 15 years post treatment
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 10 Jun 2011.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Miguel-Angel Perales, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GM-CSF DNA, NSC 683472 gp100: 209-217(210M), NSC 699048 Tyrosinase: 368-376(370D) in people with Melanoma, run by Memorial Sloan Kettering 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 10 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 10 Jun 2011. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
To establish the safety and a recommended dose of subcutaneous human GM-CSF DNA given in conjunction with a multi-epitope peptide vaccine in patients with AJCC stage IIB, IIC, III and IV melanoma who are HLA-A2+. (time frame: Up to 15 years post treatment,). The study lists 4 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 10 Jun 2011.