Melanoma (Skin)Phase 2NCT00003362
Vaccine Therapy Plus Immune Adjuvants in Treating Patients With Advanced Melanoma
A Phase 2 study testing QS21, gp100 antigen and incomplete Freund's adjuvant in people with Melanoma (Skin), run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptides that are found on melanoma cells may make the body build an immune response and kill melanoma cells. Combining vaccine therapy with immune adjuvants, such as GM-CSF, Montanide ISA-51, or QS21, may be a more effective treatment for advanced melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- QS21, gp100 antigen and incomplete Freund's adjuvant
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- May 1998to Feb 2001
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically confirmed unresectable stage III or stage IV melanoma Patients who are disease free following surgical resection or chemotherapy for stage III or IV disease also eligible HLA-A201 positive
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 5 months Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 75,000/mm3 LDH no greater than 2 times upper limit of normal No active bleeding Hepatic: Albumin at least 3.5 mg/dL Renal: Not specified Other: Not pregnant or less than 3 months postpartum Fertile patients must use effective contraception No serious underlying medical conditions No known immunodeficiency No active infection No retinal or choroidal eye disease
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No prior tyrosinase or gp100 peptides No prior Montanide ISA-51 No prior melanoma protein vaccine or melanoma whole cell vaccines No other concurrent immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior systemic steroids and recovered No concurrent systemic steroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No prior radiotherapy to the spleen No concurrent radiotherapy Surgery: Recovered from any prior surgery No prior splenectomy Other: At least 1 week since prior antiinflammatory drugs and recovered At least 1 week since prior antihistamines and recovered No concurrent antiinflammatory drugs No concurrent antihistamines No concurrent antimicrobial drugs
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Pilot Trial of Multi-Epitope Melanoma Peptide Vaccine Using GM-CSF, Montanide and QS-21 as Adjuvants
RATIONALE: Vaccines made from peptides that are found on melanoma cells may make the body build an immune response and kill melanoma cells. Combining vaccine therapy with immune adjuvants, such as GM-CSF, Montanide ISA-51, or QS21, may be a more effective treatment for advanced melanoma.
PURPOSE: Randomized phase II trial to study the effectiveness of gp 100-tyrosinase peptide vaccine with one of the immune adjuvants GM-CSF, Montanide ISA-51, or QS21 in treating patients who have stage III or stage IV melanoma.
Read the detailed description
OBJECTIVES: I. Evaluate the immunogenicity of gp100-tyrosinase peptide vaccine with sargramostim (GM-CSF), Montanide ISA-51, or QS21 as adjuvant in patients with advanced melanoma. II. Determine the toxicity of this multiepitope melanoma peptide vaccine in conjunction with these 3 adjuvants in these patients. III. Evaluate the antitumor effects of this multiepitope melanoma peptide vaccine in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to age (65 years and under vs more than 65 years) and previous systemic chemotherapy (yes vs no). Patients are randomized to 1 of 3 treatment arms: Arm I (Sargramostim (GM-CSF) as adjuvant): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine administered intradermally during weeks 1, 5, and 9. For each vaccination, GM-CSF is administered intradermally on days 1-10; the vaccine is administered on day 7. Arm II (Montanide ISA-51): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with Montanide ISA-51 and administered subcutaneously (SQ) during weeks 1, 5, and 9. Arm III (QS21 as adjuvant): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with QS21 and administered SQ during weeks 1, 5, and 9. Patients with stable or responding disease may receive 3 additional monthly immunizations beginning 3-6 months following completion of 1 course of immunizations if there is evidence of T cell response against either wild type peptide. Patients are followed at weeks 13 and 17.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 18-24 months.
- Conditions
- Melanoma (Skin)
- Being tested
- QS21, gp100 antigen, incomplete Freund's adjuvant, sargramostim, tyrosinase peptide
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QS21Biological
gp100 antigenBiological
incomplete Freund's adjuvantBiological
sargramostimBiological
tyrosinase peptideBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2004 (estimated)
- Study startMay 1998
- Primary completionFeb 2001
- Study completionFeb 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Paul B. Chapman, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003362
- Sponsor's protocol ID
- 98-012
- Other IDs
- CDR0000066345, NCI-T97-0110
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 1999
- Last updated
- 25 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Multi-Epitope Melanoma Peptide Vaccine Using GM-CSF, Montanide and QS-21 as Adjuvants
- ClinicalTrials.gov ID
- NCT00003362
- Acronym / sponsor ID
- 98-012
- Conditions
- Melanoma (Skin)
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 1998
- Primary completion
- Feb 2001 (actual)
- Study completion
- Feb 2001 (actual)
- First posted
- 26 Aug 2004 (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.
RATIONALE: Vaccines made from peptides that are found on melanoma cells may make the body build an immune response and kill melanoma cells. Combining vaccine therapy with immune adjuvants, such as GM-CSF, Montanide ISA-51, or QS21, may be a more effective treatment for advanced melanoma.
PURPOSE: Randomized phase II trial to study the effectiveness of gp 100-tyrosinase peptide vaccine with one of the immune adjuvants GM-CSF, Montanide ISA-51, or QS21 in treating patients who have stage III or stage IV melanoma.
Detailed description
OBJECTIVES: I. Evaluate the immunogenicity of gp100-tyrosinase peptide vaccine with sargramostim (GM-CSF), Montanide ISA-51, or QS21 as adjuvant in patients with advanced melanoma. II. Determine the toxicity of this multiepitope melanoma peptide vaccine in conjunction with these 3 adjuvants in these patients. III. Evaluate the antitumor effects of this multiepitope melanoma peptide vaccine in these patients.
OUTLINE: This is a randomized study. Patients are stratified according to age (65 years and under vs more than 65 years) and previous systemic chemotherapy (yes vs no). Patients are randomized to 1 of 3 treatment arms: Arm I (Sargramostim (GM-CSF) as adjuvant): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine administered intradermally during weeks 1, 5, and 9. For each vaccination, GM-CSF is administered intradermally on days 1-10; the vaccine is administered on day 7. Arm II (Montanide ISA-51): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with Montanide ISA-51 and administered subcutaneously (SQ) during weeks 1, 5, and 9. Arm III (QS21 as adjuvant): Patients receive 3 monthly vaccinations with gp100-tyrosinase peptide vaccine mixed with QS21 and administered SQ during weeks 1, 5, and 9. Patients with stable or responding disease may receive 3 additional monthly immunizations beginning 3-6 months following completion of 1 course of immunizations if there is evidence of T cell response against either wild type peptide. Patients are followed at weeks 13 and 17.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 18-24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| QS21 | Biological | – |
| gp100 antigen | Biological | – |
| incomplete Freund's adjuvant | Biological | – |
| sargramostim | Biological | – |
| tyrosinase peptide | Biological | – |
Primary outcome
Not reported in the source record.
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 25 Jun 2013.
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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.
Paul B. Chapman, MD study chair
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 Phase 2 study testing QS21, gp100 antigen and incomplete Freund's adjuvant in people with Melanoma (Skin), 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?
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 25 Jun 2013. 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 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.
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 25 Jun 2013.