Stage IIIB Skin MelanomaPhase 2NCT00925314
A Study of Transgenic Lymphocyte Immunization (TLI) Against Telomerase in Subjects With Stage III Melanoma
A Phase 2 study testing CB-10-01 (Transgenic Lymphocyte Immunization) in people with Stage IIIB Skin Melanoma and Stage IIIC Skin Melanoma, run by Cosmo Bioscience at 5 sites in United States.
Trial summary
The purpose of this study is to assess the safety, efficacy, and immunological response to the study product, TLI, as an adjuvant therapy in subjects with Stage III Melanoma. Normal cells in the body have an established lifespan. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma
- What is being tested?
- CB-10-01 (Transgenic Lymphocyte Immunization)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- Jun 2007to Jul 2014
- 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
Who may be able to join
- Male or female subjects ≥18 years of age and able to understand and give written informed consent
- Women subjects of childbearing potential (WOCBP) and male subjects must be using an effective method of contraception
- Histologic diagnosis of malignant melanoma:
- Melanoma primary completely resected with negative margins. Primary surgery must be <8 weeks from leukapheresis procedure
- Stage IIIB or Stage IIIC according to the American Joint Committee on Cancer (AJCC) Tumor-Node-Metastasis (TNM) criteria (Appendix 2) OR previously resected Stage I or II melanoma that recurs as Stage IIIB or IIIC.
- HLA-A2 positive
Show all 16Show fewer
- ECOG Performance Status of 0, 1 or 2 (Appendix 3)
- Adequate bone marrow, hepatic, and renal function:
- WBC ≥1500/μL
- ANC ≥1000/μL
- Platelets ≥100 × 103/μL
- Hemoglobin ≥9 g/dL
- Creatinine ≤2 ULN
- AST ≤2 ULN
- Bilirubin ≤2 ULN (except for subjects with Gilbert's Syndrome who must have a total bilirubin <3.0 mg/mL)
- Negative screening tests for HIV, Hepatitis B and C
Who cannot join
- Female subjects, their partners and male subjects who are unwilling or unable to practice abstinence or use a barrier method (condoms) during intercourse to minimize the risk of exposure to the blood-borne transgene for the entire period of the study and for up to 8 weeks after the last TLI infusion
- Known allergy to DMSO
- Any malignancy from which the subject has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- Primary ocular or mucosal melanoma
- Autoimmune disease: subjects with a documented history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]) that has or may require systemic therapy
- Concomitant therapy with any anticancer agent; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids (used in the management of cancer or non cancer-related illnesses). Replacement doses of corticosteroids are allowed in subjects with adrenal insufficiency
- Prior biologic therapy for melanoma
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
City of Hope
Duarte, California, 91010
University of California Los Angeles
Los Angeles, California, 90024
University of California San Diego
San Diego, California, 92093
Northern California Melanoma Center
San Francisco, California, 94117
John Wayne Cancer Institute
Santa Monica, California, 90404
About this study
Official title: A Phase 2, Open-Label Evaluation of the Safety and Efficacy of CB-10-01, Transgenic Lymphocyte Immunization (TLI) Against Telomerase, as Adjuvant Therapy in Subjects With Stage III Melanoma
The purpose of this study is to assess the safety, efficacy, and immunological response to the study product, TLI, as an adjuvant therapy in subjects with Stage III Melanoma.
Normal cells in the body have an established lifespan. Cancer cells on the other hand have the ability to continue to divide into new cells indefinitely. More than 85% of cancer has this ability because of an enzyme found in the cancer cell. The Investigational Product, Transgenic Lymphocyte Immunization (TLI), is aimed at helping the immune system target this enzyme found in most cancerous cells.
Subjects who meet all inclusion and exclusion criteria will undergo a leukapheresis in which white blood cells will be collected and used to manufacture their own personal study product. Subjects will receive 3 infusions of TLI roughly 1 month apart and will be followed over a 2 year period with routine laboratory draws, computed tomography (CT) scans and physical exams.
- Conditions
- Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma
- Being tested
- CB-10-01 (Transgenic Lymphocyte Immunization)
- Keywords
- Stage III Melanoma, Melanoma, TLI, Transgenic Lymphocyte Immunization, CB-10-01-02
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CB-10-01 (Transgenic Lymphocyte Immunization)Biological
Also called TLI
1 Primary Infusion and 2 Booster Infusions
| Study group | Role | What they receive |
|---|---|---|
| Transgenic Lymphocyte Immunization | Experimental | Open Label, Single Arm Receives: Biological: CB-10-01 (Transgenic Lymphocyte Immunization) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint will be the percentage of subjects who have no recurrence of metastatic melanoma at 24 months from the time of primary surgery.
Measured: 24 months
Secondary outcomes (1)
Percentage of subjects who have no recurrence of metastatic melanoma 9 and 16 months following the time of primary surgery.
Measured: 9 and 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
- Study startJun 2007
- Primary completionJul 2011
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage IIIB Skin MelanomaStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cosmo Bioscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Daniels, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925314
- Sponsor's protocol ID
- CB-10-01-02
- Status last verified
- Feb 2012
- First submitted
- 18 Jun 2009
- Last updated
- 13 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Open-Label Evaluation of the Safety and Efficacy of CB-10-01, Transgenic Lymphocyte Immunization (TLI) Against Telomerase, as Adjuvant Therapy in Subjects With Stage III Melanoma
- ClinicalTrials.gov ID
- NCT00925314
- Acronym / sponsor ID
- CB-10-01-02
- Conditions
- Stage IIIB Skin Melanoma, Stage IIIC Skin Melanoma
- Keywords
- Stage III Melanoma, Melanoma, TLI, Transgenic Lymphocyte Immunization, CB-10-01-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cosmo BioscienceIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2014 (estimated)
- First posted
- 22 Jun 2009 (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.
The purpose of this study is to assess the safety, efficacy, and immunological response to the study product, TLI, as an adjuvant therapy in subjects with Stage III Melanoma.
Normal cells in the body have an established lifespan. Cancer cells on the other hand have the ability to continue to divide into new cells indefinitely. More than 85% of cancer has this ability because of an enzyme found in the cancer cell. The Investigational Product, Transgenic Lymphocyte Immunization (TLI), is aimed at helping the immune system target this enzyme found in most cancerous cells.
Subjects who meet all inclusion and exclusion criteria will undergo a leukapheresis in which white blood cells will be collected and used to manufacture their own personal study product. Subjects will receive 3 infusions of TLI roughly 1 month apart and will be followed over a 2 year period with routine laboratory draws, computed tomography (CT) scans and physical exams.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transgenic Lymphocyte Immunization | Experimental | Biological: CB-10-01 (Transgenic Lymphocyte Immunization)Open Label, Single Arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male or female subjects ≥18 years of age and able to understand and give written informed consent
- Women subjects of childbearing potential (WOCBP) and male subjects must be using an effective method of contraception
- Histologic diagnosis of malignant melanoma:
- HLA-A2 positive
- ECOG Performance Status of 0, 1 or 2 (Appendix 3)
Key exclusion criteria (7 listed)
- Female subjects, their partners and male subjects who are unwilling or unable to practice abstinence or use a barrier method (condoms) during intercourse to minimize the risk of exposure to the blood-borne transgene for the entire period of the study and for up to 8 weeks after the last TLI infusion
- Known allergy to DMSO
- Any malignancy from which the subject has been disease-free for less than 5 years, with the exception of adequately treated and cured basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix
- Primary ocular or mucosal melanoma
- Autoimmune disease: subjects with a documented history of symptomatic autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]) that has or may require systemic therapy
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 |
|---|---|---|
| CB-10-01 (Transgenic Lymphocyte Immunization)Also: TLI1 Primary Infusion and 2 Booster Infusions | Biological | Transgenic Lymphocyte Immunization |
Primary outcome
The primary efficacy endpoint will be the percentage of subjects who have no recurrence of metastatic melanoma at 24 months from the time of primary surgery.
Time frame: 24 months
1 secondary outcome
Percentage of subjects who have no recurrence of metastatic melanoma 9 and 16 months following the time of primary surgery.
Time frame: 9 and 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2012.
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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.
Gregory Daniels, MD, PhD principal investigator
University of California, San Diego
5 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 CB-10-01 (Transgenic Lymphocyte Immunization) in people with Stage IIIB Skin Melanoma and Stage IIIC Skin Melanoma, run by Cosmo Bioscience at 5 sites 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 16 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: status not confirmed, as of the sponsor's last update on 13 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
The primary efficacy endpoint will be the percentage of subjects who have no recurrence of metastatic melanoma at 24 months from the time of primary surgery. (time frame: 24 months). 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 13 Feb 2012.