Melanoma (Skin)Phase 1NCT00003665
Vaccine Therapy in Treating Patients With Stage IV Melanoma
A Phase 1 study testing dendritic cell-MART-1 peptide vaccine, gp100 antigen and therapeutic tumor infiltrating lymphocytes in people with Melanoma (Skin), run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma. Vaccines may make the body build an immune response to kill tumor cells. 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?
- dendritic cell-MART-1 peptide vaccine, gp100 antigen and therapeutic tumor infiltrating lymphocytes
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1999to Nov 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
DISEASE CHARACTERISTICS:
-Histologically confirmed stage IV melanoma Must be MHC Class I HLA-A2.1
PATIENT CHARACTERISTICS:
- Age: Over 18
- Performance status: ECOG 0-1
- Life expectancy: At least 2 months
- Platelet count at least 100,000/mm3
- INR no greater than 1.5 mg/dL
- No coagulopathies including thrombocytopenia
- Partial thromboplastin time no greater than 50 seconds
- No major cardiac illness
- No major respiratory illness
- No active systemic infection or other illness
- No peripheral vascular disease
- Not pregnant or nursing
- Effective contraception required of all fertile patients during and for one month after completion of treatment
PRIOR CONCURRENT THERAPY:
- At least 30 days since prior immunotherapy
- No concurrent immunotherapy
- At least 30 days since prior chemotherapy
- No concurrent chemotherapy
- At least 30 days since prior radiotherapy
- No concurrent radiotherapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: Phase I Trial of a Dendritic Cell Vaccine for Melanoma
Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma. Vaccines may make the body build an immune response to kill tumor cells.
Read the detailed description
OBJECTIVES:
- Determine the dose-limiting toxicities, maximum tolerated dose, recommended phase II dose, and rate of sensitization of T cells at each dose level in patients with melanoma receiving dendritic cell vaccine.
II. Determine the overall (complete and partial) response rate, duration of response, and optimal route of administration in this patient population.
OUTLINE: This is a dose escalation study. Patients are randomized to one of three treatment arms.
All patients undergo leukopheresis to obtain lymphocyte and myeloid origin mononuclear cell fractions for preparation of dendritic cell (DC) vaccine. In each arm, cohorts of up to 5 patients receive escalating doses of vaccine. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 5 patients experience dose-limiting toxicity. Randomization ceases if the MTD has been reached in 2 arms, although accrual may continue. Treatment repeats every 2 weeks for a total of 4 doses.
Arm I: Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into 3 different peptide pulsed pools administered over 30 minutes.
Arm II: Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose, patients receive 3 different peptide pulsed pools, each administered at a separate site. At the higher doses, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites.
Arm III: Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose, patients receive 3 different peptide pulsed pools, each administered into a different node. At the higher dose, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites.
Patients are followed at 2 weeks and then monthly for 3 months.
- Conditions
- Melanoma (Skin)
- Being tested
- dendritic cell-MART-1 peptide vaccine, gp100 antigen, therapeutic tumor infiltrating lymphocytes, tyrosinase peptide
- 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
gp100 antigenBiological
therapeutic tumor infiltrating lymphocytesBiological
tyrosinase peptideBiological
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into 3 different peptide pulsed pools administered over 30 minutes. Receives: Biological: dendritic cell-MART-1 peptide vaccine; Biological: gp100 antigen; Biological: therapeutic tumor infiltrating lymphocytes; Biological: tyrosinase peptide |
| Arm II | Experimental | Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose, patients receive 3 different peptide pulsed pools, each administered at a separate site. At the higher doses, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites. Receives: Biological: dendritic cell-MART-1 peptide vaccine; Biological: gp100 antigen; Biological: therapeutic tumor infiltrating lymphocytes; Biological: tyrosinase peptide |
| Arm III | Experimental | Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose, patients receive 3 different peptide pulsed pools, each administered into a different node. At the higher dose, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites. Receives: Biological: dendritic cell-MART-1 peptide vaccine; Biological: gp100 antigen; Biological: therapeutic tumor infiltrating lymphocytes; Biological: tyrosinase peptide |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2004 (estimated)
- Study startApr 1999
- Primary completionOct 2002
- Study completionNov 2002
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 National Cancer Institute (NCI)The 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Brian J. Czerniecki, MD, PhD, Study chair, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003665
- Sponsor's protocol ID
- NCI-2012-02292
- Other IDs
- UPCC-4697, NCI-T98-0033, CDR0000066759
- Status last verified
- Feb 2013
- First submitted
- 1 Nov 1999
- Last updated
- 28 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of a Dendritic Cell Vaccine for Melanoma
- ClinicalTrials.gov ID
- NCT00003665
- Acronym / sponsor ID
- NCI-2012-02292
- Conditions
- Melanoma (Skin)
- Keywords
- stage IV melanoma, recurrent melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Apr 1999
- Primary completion
- Oct 2002 (actual)
- Study completion
- Nov 2002 (actual)
- First posted
- 9 Feb 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.
Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have stage IV melanoma. Vaccines may make the body build an immune response to kill tumor cells.
Detailed description
OBJECTIVES:
- Determine the dose-limiting toxicities, maximum tolerated dose, recommended phase II dose, and rate of sensitization of T cells at each dose level in patients with melanoma receiving dendritic cell vaccine.
II. Determine the overall (complete and partial) response rate, duration of response, and optimal route of administration in this patient population.
OUTLINE: This is a dose escalation study. Patients are randomized to one of three treatment arms.
All patients undergo leukopheresis to obtain lymphocyte and myeloid origin mononuclear cell fractions for preparation of dendritic cell (DC) vaccine. In each arm, cohorts of up to 5 patients receive escalating doses of vaccine. The maximum tolerated dose (MTD) is defined as the dose preceding that at which 2 or more of 5 patients experience dose-limiting toxicity. Randomization ceases if the MTD has been reached in 2 arms, although accrual may continue. Treatment repeats every 2 weeks for a total of 4 doses.
Arm I: Patients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into 3 different peptide pulsed pools administered over 30 minutes.
Arm II: Patients receive 3 different doses of peptide pulsed DC vaccine subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose, patients receive 3 different peptide pulsed pools, each administered at a separate site. At the higher doses, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites.
Arm III: Patients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose, patients receive 3 different peptide pulsed pools, each administered into a different node. At the higher dose, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites.
Patients are followed at 2 weeks and then monthly for 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: dendritic cell-MART-1 peptide vaccine, Biological: gp100 antigen, Biological: therapeutic tumor infiltrating lymphocytes, Biological: tyrosinase peptidePatients receive 3 different doses of peptide pulsed DC vaccine IV, each divided into 3 different peptide pulsed pools administered over 30 minutes. |
| Arm II | Experimental | Biological: dendritic cell-MART-1 peptide vaccine, Biological: gp100 antigen, Biological: therapeutic tumor infiltrating lymphocytes, Biological: tyrosinase peptidePatients receive 3 different doses of peptide pulsed DC vaccine subcutaneously/intradermally to sites with no evidence of disease. At the lowest dose, patients receive 3 different peptide pulsed pools, each administered at a separate site. At the higher doses, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites. |
| Arm III | Experimental | Biological: dendritic cell-MART-1 peptide vaccine, Biological: gp100 antigen, Biological: therapeutic tumor infiltrating lymphocytes, Biological: tyrosinase peptidePatients receive peptide pulsed DC vaccine intranodally in groin or ancillary lymph nodes at the lower 2 doses of the 3 administered to arms I and II. At the lower dose, patients receive 3 different peptide pulsed pools, each administered into a different node. At the higher dose, patients receive 3 injections further subdivided into 6 and administered at 6 distinct sites. |
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 |
|---|---|---|
| dendritic cell-MART-1 peptide vaccine | Biological | Arm I, Arm II, Arm III |
| gp100 antigen | Biological | Arm I, Arm II, Arm III |
| therapeutic tumor infiltrating lymphocytes | Biological | Arm I, Arm II, Arm III |
| tyrosinase peptide | Biological | Arm I, Arm II, Arm III |
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 28 Feb 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.
Brian J. Czerniecki, MD, PhD study chair
Abramson Cancer Center at Penn Medicine
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, gp100 antigen and therapeutic tumor infiltrating lymphocytes in people with Melanoma (Skin), run by National Cancer Institute (NCI) 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 28 Feb 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 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 28 Feb 2013.