Melanoma (Skin)Phase 2NCT00107159
Vaccine Therapy in Treating Patients With Unresected Stage III or Stage IV Melanoma
A Phase 2 study testing autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine in people with Melanoma (Skin), run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Vaccines made from a person's white blood cells and a donor's tumor cells may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV 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?
- autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine
- Type of treatment
- Vaccines
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Sep 2010
- 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 primary cutaneous or unknown primary melanoma, including 1 of the following stages:
- Stage IIIB or IIIC disease
- Unresected, in-transit lymph node metastases (N2c or N3)
- Stage IV disease
- Distant skin, subcutaneous, lymph node, or pulmonary metastases (M1a or M1b)
- No cerebral, bone, or other visceral metastases
- At least 1 measurable or evaluable lesion
- Small-volume multiple cutaneous deposits allowed
- Progressive disease, as defined by 1 of the following criteria:
- At least 20% increase in size in ≥ 1 measurable or evaluable lesion
- Appearance of ≥ 1 new lesion since or during last treatment (if applicable) AND within the past 3 months
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- At least 6 months
Hematopoietic
- WBC ≥ 3,000/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin ≥ 10.0 g/dL (transfusion allowed)
Hepatic
- SGOT and SGPT ≤ 2.5 times upper limit of normal (ULN)
- Lactic dehydrogenase normal
- No active hepatitis B or C infection
Renal
- Creatinine ≤ 1.5 times ULN
Immunologic
- No history of autoimmune disease
- Vitiligo allowed
- No history of immunodeficiency syndrome
- No active bacterial, viral, or fungal infection within the past 72 hours
- HIV-1 or -2 negative
- Human T-cell lymphotrophic virus-I or -II negative
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No contraindication to apheresis
- No other significant medical or surgical condition that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior vaccine therapy with ≥ 1 melanoma antigen or peptide
- More than 4 weeks since prior biologic therapy
Chemotherapy
- More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
Endocrine therapy
- No concurrent chronic systemic corticosteroids
Radiotherapy
- More than 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- More than 4 weeks since prior investigational products
- More than 4 weeks since prior chronic systemic immunosuppressive treatment
- No concurrent medication or treatment regimen that would prelude study participation
- No other concurrent anticancer treatment
- No other concurrent immunosuppressive treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: A Phase II Study Of Matured Dendritic Cells Pulsed Ex Vivo With 3 Melanoma Cell Line Lysates (IDD-3) in Patients With In-Transit or Metastatic Melanoma
RATIONALE: Vaccines made from a person's white blood cells and a donor's tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Determine the clinical activity of vaccine therapy comprising autologous dendritic cells pulsed with allogeneic melanoma tumor cell lysates (IDD-3), as measured by tumor control, in patients with unresected stage IIIB or IIIC or stage IV melanoma.
Secondary
- Determine the immunologic activity of this vaccine, as measured by T-cell and antibody responses to lysate or to melanoma antigens or peptides, in these patients.
- Determine the safety of this vaccine, as measured by the incidence and severity of adverse events, in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). The PBMCs are cultured with sargramostim (GM-CSF) and interleukin-13 for the production of dendritic cells. The dendritic cells are then pulsed with lysates from 3 allogeneic melanoma tumor cell lines (IDD-3) to produce the vaccine.
Patients receive vaccine therapy comprising IDD-3 administered as 1 subcutaneous and 5 intradermal injections at each of the 2 uninvolved lymph node-bearing regions once in weeks 0, 2, 4, 6, 8, 10, 16, and 22 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 2, 10, 18, and 26 weeks.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.
- Conditions
- Melanoma (Skin)
- Being tested
- autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine
- 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-allogeneic melanoma tumor cell lysate vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks
Secondary outcomes (2)
Safety
Immune response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2005 (estimated)
- Study startJan 2005
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Antoni Ribas, MD, Study chair, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00107159
- Sponsor's protocol ID
- CDR0000422429
- Other IDs
- UCLA-0408080-01, IDM-DC-MEL-202
- Status last verified
- Apr 2007
- First submitted
- 5 Apr 2005
- Last updated
- 6 Nov 2013
- Results posted
- No
Publications
Ribas A, Camacho LH, Lee SM, Hersh EM, Brown CK, Richards JM, Rodriguez MJ, Prieto VG, Glaspy JA, Oseguera DK, Hernandez J, Villanueva A, Chmielowski B, Mitsky P, Bercovici N, Wasserman E, Landais D, Ross MI. Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma. J Transl Med. 2010 Sep 27;8:89. doi: 10.1186/1479-5876-8-89.
PubMed 20875102
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Matured Dendritic Cells Pulsed Ex Vivo With 3 Melanoma Cell Line Lysates (IDD-3) in Patients With In-Transit or Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00107159
- Acronym / sponsor ID
- CDR0000422429
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma, stage III melanoma, stage IV melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2005
- Study completion
- Sep 2010 (actual)
- First posted
- 6 Apr 2005 (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 person's white blood cells and a donor's tumor cells may help the body build an effective immune response to kill tumor cells.
PURPOSE: This phase II trial is studying how well vaccine therapy works in treating patients with unresected stage III or stage IV melanoma.
Detailed description
OBJECTIVES:
Primary
- Determine the clinical activity of vaccine therapy comprising autologous dendritic cells pulsed with allogeneic melanoma tumor cell lysates (IDD-3), as measured by tumor control, in patients with unresected stage IIIB or IIIC or stage IV melanoma.
Secondary
- Determine the immunologic activity of this vaccine, as measured by T-cell and antibody responses to lysate or to melanoma antigens or peptides, in these patients.
- Determine the safety of this vaccine, as measured by the incidence and severity of adverse events, in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients undergo apheresis to collect peripheral blood mononuclear cells (PBMCs). The PBMCs are cultured with sargramostim (GM-CSF) and interleukin-13 for the production of dendritic cells. The dendritic cells are then pulsed with lysates from 3 allogeneic melanoma tumor cell lines (IDD-3) to produce the vaccine.
Patients receive vaccine therapy comprising IDD-3 administered as 1 subcutaneous and 5 intradermal injections at each of the 2 uninvolved lymph node-bearing regions once in weeks 0, 2, 4, 6, 8, 10, 16, and 22 in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 2, 10, 18, and 26 weeks.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study within 4-12 months.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
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 |
|---|---|---|
| autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine | Biological | – |
Primary outcome
Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks
2 secondary outcomes
Safety
Immune response
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 6 Nov 2013.
- Results publication: PubMed 20875102Ribas A, Camacho LH, Lee SM, Hersh EM, Brown CK, Richards JM, Rodriguez MJ, Prieto VG, Glaspy JA, Oseguera DK, Hernandez J, Villanueva A, Chmielowski B, Mitsky P, Bercovici N, Wasserman E, Landais D, Ross MI. Multicenter phase II study of matured dendritic cells pulsed with melanoma cell line lysates in patients with advanced melanoma. J Transl Med. 2010 Sep 27;8:89. doi: 10.1186/1479-5876-8-89.
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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.
Antoni Ribas, MD study chair
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 2 study testing autologous dendritic cell-allogeneic melanoma tumor cell lysate vaccine in people with Melanoma (Skin), 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?
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 6 Nov 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.
What does the primary outcome measure?
Tumor control rate (complete response, partial response, or stable disease) for 4-8 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00107159, which also lists 1 linked publication.
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 6 Nov 2013.