MelanomaPhase 1NCT00005617
Vaccine Therapy in Treating Patients With Stage IV or Relapsed Malignant Melanoma
A Phase 1 study testing dendritic cell-MART-1 peptide vaccine and leukapheresis in people with Melanoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV, or relapsed malignant melanoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- dendritic cell-MART-1 peptide vaccine and leukapheresis
- Type of treatment
- Vaccines, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 1997to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults over the age of 18 with malignant melanoma.
- HLA-A2.1 positive and express MART-1, as assessed by either RT-PCR or by immunohistochemistry
- Tumor stages T3N0M0 or greater are eligible for this trial according to the following:
- I (<.75 to 1.5 mm or Clark level III-T1-2N0M0-)-not eligible
- II (1.5 to 4 mm or level IV-T3N0M0-)-eligible
- III (limited nodal metastasis involving one regional lymph node basin, or fewer than 5 in-transit metastasis -TxN1M0-)-eligible
Show all 21Show fewer
- IV (advanced regional metastasis -TxN2M0- or any distant metastasis -TxNxM1-)-eligible
- Relapsed melanoma-eligible
- Patients previously treated with any form of therapy for either metastatic, relapsed or primary melanoma are eligible for this trial, provided that previous treatment was completed >30 days prior to enrollment
- Both male and females may be enrolled. Premenopausal females must have a negative pregnancy test prior to treatment
- Karnofsky Performance Status greater than or equal to 70 percent
- No previous evidence of class 3 or greater New York Heart Association cardiac insufficiency or coronary artery disease
- No previous evidence of opportunistic infection
- A minimum of 30 days must have elapsed since the completion of prior chemotherapy, immunotherapy or radiation therapy
- Adequate baseline hematological function as assessed by the following laboratory values within 30 days prior to study entry (day -30 to 0):
- Hemoglobin >9.0 g/dl
- Platelets > 100000/mm3
- WBC > 3000/mm3
- Absolute Neutrophil Count > 1000/mm3
- Positive skin test to common antigens (tetanus and candida)
- Ability to give informed consent
Who cannot join
- Lactating females and females of child-bearing potential must have negative serum beta-HCG pregnancy test
- Acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy. Acute therapy must have been completed within 14 days of prior to study treatment
- HIV-infected patients
- Acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk
- Patients with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents used in this study)
- Patients with organ allografts
- Uncontrolled CNS metastasis. Patients with CNS metastasis will be eligible if they have received CNS irradiation to control local tumor growth
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Phase I Trial Testing Mart-1 Peptide Immunization in Malignant Melanoma
RATIONALE: Vaccines made from peptides may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV, or relapsed malignant melanoma.
Read the detailed description
OBJECTIVES:
- Determine the safety of administering MART-1 peptide-pulsed dendritic cells to patients with stage IV or relapsed malignant melanoma.
- Determine the immunological and clinical responses in this patient population after this therapy.
OUTLINE: This is a dose-escalation study.
Patients undergo leukapheresis between days -14 to -8. Mononuclear cells are isolated, used to generate dendritic cells (DC), and then pulsed with MART-1 peptide. Patients are vaccinated with MART-1 peptide-pulsed DC either IV or intradermally on days 0, 14, and 28.
Cohorts of 3-6 patients receive escalating doses of MART-1 peptide-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.
- Conditions
- Melanoma
- Being tested
- dendritic cell-MART-1 peptide vaccine, leukapheresis
- Keywords
- 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.
dendritic cell-MART-1 peptide vaccineBiological
Number DC: dependent on the group route of immunization: dependent on the group subjects will receive 3 biweekly vaccinations. In case of grade III-IV toxicity in 1/3 subjects at any dose group or route, up to 6 subjects will be included in that group.
leukapheresisProcedure or surgery
Patients require a single leukapheresis to obtain 2x10^9 PBL, which are cryopreserved in RPMI 1640, 20% autologous serum, 10% DMSO. Aliquots are thawed at days -7, 7 and 21 for the first, second, and third immunizations respectively. Blood is drawn at the time of leukapheresis and on the day of the first vaccination for autologous serum, which is sufficient for the cell cultures of all patient groups.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | No. DC: 10^5 Route of Immunization: ID Receives: Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis |
| Group B | Experimental | No. DC: 10^5 Route of Immunization: IV Receives: Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis |
| Group C | Experimental | No. DC: 10^6 Route of Immunization: ID Receives: Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis |
| Group D | Experimental | No. DC: 10^6 Route of Immunization: IV Receives: Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis |
| Group E | Experimental | No. DC: 10^7 Route of Immunization: ID Receives: Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis |
| Group F | Experimental | No. DC: 10^7 Route of Immunization: IV Receives: Biological: dendritic cell-MART-1 peptide vaccine; Procedure: leukapheresis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJul 1997
- Primary completionJun 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.
- More trials run by Jonsson Comprehensive 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 1
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John A Glaspy, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005617
- Sponsor's protocol ID
- CDR0000067754
- Other IDs
- UCLA-9508375, NCI-H00-0050
- Status last verified
- Jul 2012
- First submitted
- 2 May 2000
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial Testing Mart-1 Peptide Immunization in Malignant Melanoma
- ClinicalTrials.gov ID
- NCT00005617
- Acronym / sponsor ID
- CDR0000067754
- Conditions
- Melanoma
- Keywords
- stage IV melanoma, recurrent melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jul 1997
- Primary completion
- Jun 2002 (actual)
- First posted
- 27 Jan 2003 (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 may make the body build an immune response to kill tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of vaccine therapy in treating patients who have stage IV, or relapsed malignant melanoma.
Detailed description
OBJECTIVES:
- Determine the safety of administering MART-1 peptide-pulsed dendritic cells to patients with stage IV or relapsed malignant melanoma.
- Determine the immunological and clinical responses in this patient population after this therapy.
OUTLINE: This is a dose-escalation study.
Patients undergo leukapheresis between days -14 to -8. Mononuclear cells are isolated, used to generate dendritic cells (DC), and then pulsed with MART-1 peptide. Patients are vaccinated with MART-1 peptide-pulsed DC either IV or intradermally on days 0, 14, and 28.
Cohorts of 3-6 patients receive escalating doses of MART-1 peptide-pulsed DC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Patients are followed until death.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: dendritic cell-MART-1 peptide vaccine, Procedure: leukapheresisNo. DC: 10^5 Route of Immunization: ID |
| Group B | Experimental | Biological: dendritic cell-MART-1 peptide vaccine, Procedure: leukapheresisNo. DC: 10^5 Route of Immunization: IV |
| Group C | Experimental | Biological: dendritic cell-MART-1 peptide vaccine, Procedure: leukapheresisNo. DC: 10^6 Route of Immunization: ID |
| Group D | Experimental | Biological: dendritic cell-MART-1 peptide vaccine, Procedure: leukapheresisNo. DC: 10^6 Route of Immunization: IV |
| Group E | Experimental | Biological: dendritic cell-MART-1 peptide vaccine, Procedure: leukapheresisNo. DC: 10^7 Route of Immunization: ID |
| Group F | Experimental | Biological: dendritic cell-MART-1 peptide vaccine, Procedure: leukapheresisNo. DC: 10^7 Route of Immunization: IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Adults over the age of 18 with malignant melanoma.
- HLA-A2.1 positive and express MART-1, as assessed by either RT-PCR or by immunohistochemistry
- Tumor stages T3N0M0 or greater are eligible for this trial according to the following:
- Patients previously treated with any form of therapy for either metastatic, relapsed or primary melanoma are eligible for this trial, provided that previous treatment was completed >30 days prior to enrollment
- Both male and females may be enrolled. Premenopausal females must have a negative pregnancy test prior to treatment
Key exclusion criteria (7 listed)
- Lactating females and females of child-bearing potential must have negative serum beta-HCG pregnancy test
- Acute infection: any acute viral, bacterial, or fungal infection which requires specific therapy. Acute therapy must have been completed within 14 days of prior to study treatment
- HIV-infected patients
- Acute medical problems such as ischemic heart or lung disease that may be considered an unacceptable anesthetic or operative risk
- Patients with any underlying conditions which would contraindicate therapy with study treatment (or allergies to reagents used in this study)
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 |
|---|---|---|
| dendritic cell-MART-1 peptide vaccineNumber DC: dependent on the group route of immunization: dependent on the group subjects will receive 3 biweekly vaccinations. In case of grade III-IV toxicity in 1/3 subjects at any dose group or route, up to 6 subjects will be included in that group. | Biological | Group A, Group B, Group C, Group D, Group E, Group F |
| leukapheresisPatients require a single leukapheresis to obtain 2x10^9 PBL, which are cryopreserved in RPMI 1640, 20% autologous serum, 10% DMSO. Aliquots are thawed at days -7, 7 and 21 for the first, second, and third immunizations respectively. Blood is drawn at the time of leukapheresis and on the day of the first vaccination for autologous serum, which is sufficient for the cell cultures of all patient groups. | Procedure or surgery | Group A, Group B, Group C, Group D, Group E, Group F |
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 3 Aug 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.
John A Glaspy, MD principal investigator
Jonsson Comprehensive 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 1 study testing dendritic cell-MART-1 peptide vaccine and leukapheresis in people with Melanoma, run by Jonsson Comprehensive 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 21 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 Aug 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.
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.
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 Aug 2020.