Melanoma (Skin)Phase 2NCT00085397
Vaccine Therapy in Treating Patients With Stage III or Stage IV Melanoma
A Phase 2 study testing autologous dendritic cell-tumor fusion vaccine, gp100 antigen and therapeutic autologous dendritic cells in people with Melanoma (Skin), run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
RATIONALE: Vaccines made from a patient's dendritic cells may make the body build an immune response to kill tumor cells. It is not yet known whether combining vaccine therapy with either gp100 antigen or the patient's tumor cells will cause a stronger immune response and kill more tumor cells. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- autologous dendritic cell-tumor fusion vaccine, gp100 antigen and therapeutic autologous dendritic cells
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2004to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed cutaneous melanoma
- Stage III or IV disease
- Recurrent or de novo stage III disease allowed if disease is unresectable and no definitive treatment is available
- gp100- and HLA-A201-positive
- Surgically accessible tumor, defined by 1 of the following:
- Pulmonary lesions approachable by thoracoscopic procedure
- Skin or superficial soft tissue or lymph node lesions amenable to resection under local anesthesia
- Malignant ascites or pleural effusion
- Measurable disease in addition to surgically accessible tumor > 2.0 cm
- No CNS metastases
- No mucosal or ocular melanoma
PATIENT CHARACTERISTICS:
Age
- Any age
Performance status
- ECOG 0-1
Life expectancy
- More than 3 months
Hematopoietic
- WBC > 3,000/mm^3
- Platelet count > 75,000/mm^3
Hepatic
- Bilirubin < 2.0 mg/dL
Renal
- Creatinine < 2.0 mg/dL
Immunologic
- No active infection requiring treatment
- No clinically significant autoimmune disorder
- No immune deficiency disorder
- HIV negative
Other
- Antecubital vein accessible for leukapheresis
- No other malignancy within the past 5 years except nonmelanoma skin cancer or squamous cell carcinoma in situ of the cervix
- No pre-existing comorbid disease that would preclude study compliance
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior melanoma vaccine therapy
- More than 6 weeks since prior immunotherapy
Chemotherapy
- No prior chemotherapy for metastatic melanoma
Endocrine therapy
- No concurrent corticosteroids
Radiotherapy
- More than 6 weeks since prior radiotherapy
Surgery
- Not specified
Other
- No concurrent systemic immunosuppressive therapy
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Clinical Trials Office - Massachusetts General Hospital, 877-726-5130
- Recruiting
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, 02115
F. Stephen Hodi, MD, 617-632-5053
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Clinical Trials Office - Beth Israel Deaconess Medical Center, 617-667-9925
About this study
Official title: A Randomized Phase II Study of Immunization Against Melanoma Comparing Autologous Dendritic Cells Pulsed With gp100 Peptide to Autologous Dendritic Cells Fused With Autologous Tumor Cells
RATIONALE: Vaccines made from a patient's dendritic cells may make the body build an immune response to kill tumor cells. It is not yet known whether combining vaccine therapy with either gp100 antigen or the patient's tumor cells will cause a stronger immune response and kill more tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy and gp100 antigen to see how well they work compared to vaccine therapy and patient's tumor cells in treating patients with stage III or stage IV melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Compare the tumor-specific immune response, in terms of the number of gp100-specific cytotoxic T-lymphocytes, T-cell production of interferon gamma, or T-cell proliferation in response to in vitro exposure to gp100 and tumor lysate, in patients with stage III or IV melanoma treated with autologous dendritic cells (DC) pulsed with gp100 antigen vs autologous DC fused with autologous tumor cells.
Secondary
- Compare the safety and toxicity of these regimens in these patients.
- Compare the therapeutic effect of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
All patients undergo leukapheresis. Peripheral blood mononuclear cells are cultured to generate dendritic cells (DC).
- Arm I: Patients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising DC fused with autologous tumor cells subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who achieve a partial (PR) or complete response (CR) may receive an additional 3 courses.
- Arm II: Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses.
In both arms, patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.
- Conditions
- Melanoma (Skin)
- Being tested
- autologous dendritic cell-tumor fusion vaccine, gp100 antigen, therapeutic autologous dendritic cells
- Keywords
- recurrent melanoma, stage III melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous dendritic cell-tumor fusion vaccineBiological
Given subcutaneously
gp100 antigenBiological
Given IV
therapeutic autologous dendritic cellsBiological
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising dendritic cells (DC) fused with autologous tumor cells subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who achieve a partial (PR) or complete response (CR) may receive an additional 3 courses. Receives: Biological: autologous dendritic cell-tumor fusion vaccine |
| Arm II | Experimental | Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses. Receives: Biological: gp100 antigen; Biological: therapeutic autologous dendritic cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startMar 2004
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 Dana-Farber Cancer InstituteThe 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
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Frank Haluska, MD, PhD, Principal investigator, Massachusetts General HospitalDavid Avigan, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00085397
- Sponsor's protocol ID
- CDR0000369699
- Other IDs
- DFCI-03123
- Status last verified
- Apr 2008
- First submitted
- 10 Jun 2004
- Last updated
- 9 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Immunization Against Melanoma Comparing Autologous Dendritic Cells Pulsed With gp100 Peptide to Autologous Dendritic Cells Fused With Autologous Tumor Cells
- ClinicalTrials.gov ID
- NCT00085397
- Acronym / sponsor ID
- CDR0000369699
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma, stage III melanoma, stage IV melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2004
- First posted
- 11 Jun 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 a patient's dendritic cells may make the body build an immune response to kill tumor cells. It is not yet known whether combining vaccine therapy with either gp100 antigen or the patient's tumor cells will cause a stronger immune response and kill more tumor cells.
PURPOSE: This randomized phase II trial is studying vaccine therapy and gp100 antigen to see how well they work compared to vaccine therapy and patient's tumor cells in treating patients with stage III or stage IV melanoma.
Detailed description
OBJECTIVES:
Primary
- Compare the tumor-specific immune response, in terms of the number of gp100-specific cytotoxic T-lymphocytes, T-cell production of interferon gamma, or T-cell proliferation in response to in vitro exposure to gp100 and tumor lysate, in patients with stage III or IV melanoma treated with autologous dendritic cells (DC) pulsed with gp100 antigen vs autologous DC fused with autologous tumor cells.
Secondary
- Compare the safety and toxicity of these regimens in these patients.
- Compare the therapeutic effect of these regimens in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.
All patients undergo leukapheresis. Peripheral blood mononuclear cells are cultured to generate dendritic cells (DC).
- Arm I: Patients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising DC fused with autologous tumor cells subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who achieve a partial (PR) or complete response (CR) may receive an additional 3 courses.
- Arm II: Patients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses.
In both arms, patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: autologous dendritic cell-tumor fusion vaccinePatients undergo surgical harvesting of tumor cells for subsequent fusion. Patients receive vaccination comprising dendritic cells (DC) fused with autologous tumor cells subcutaneously on day 1. Treatment repeats every 21 days for 3 courses. Patients who achieve a partial (PR) or complete response (CR) may receive an additional 3 courses. |
| Arm II | Experimental | Biological: gp100 antigen, Biological: therapeutic autologous dendritic cellsPatients receive vaccination comprising DC pulsed with gp100 antigen IV on day 1. Treatment repeats every 21 days for 6 courses. Patients who achieve a PR or CR may receive an additional 6 courses. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| autologous dendritic cell-tumor fusion vaccineGiven subcutaneously | Biological | Arm I |
| gp100 antigenGiven IV | Biological | Arm II |
| therapeutic autologous dendritic cellsGiven IV | Biological | Arm II |
Primary outcome
Immune response
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2009.
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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.
Frank Haluska, MD, PhD principal investigator
Massachusetts General Hospital
David Avigan, MD principal investigator
Beth Israel Deaconess Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous dendritic cell-tumor fusion vaccine, gp100 antigen and therapeutic autologous dendritic cells in people with Melanoma (Skin), run by Dana-Farber Cancer Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune response. 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 9 Feb 2009.