MelanomaPhase 2NCT00885534
Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma
A Phase 2 study testing Cisplatin, Vinblastine, Temozolomide in people with Melanoma and Skin Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other investigators have used CVT in melanoma patients and found that tumors got significantly smaller in 30-40% of cases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Skin Cancer
- What is being tested?
- Cisplatin, Vinblastine, Temozolomide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18 years
- Histologic proof of melanoma reviewed and confirmed at MSKCC
- Patients must have stage IV melanoma or recurrent stage IIIb or IIIc melanoma. Patients who are potentially respectable will be eligible.
- Measurable disease (RECIST criteria). Patients must have a tumor amenable to biopsy for oligonucleotide microarray analysis and for immunohistochemistry. A pre-treatment biopsy is required; a fine needle aspirate is not adequate.
- No prior cytotoxic chemotherapy for melanoma. Prior immunotherapy or anti-angiogenic therapy is allowed.
- No other concurrent chemotherapy, immunotherapy, or radiotherapy
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- ECOG performance status ≤ 1
- Adequate organ function defined as follows: ANC >1500/mm3, Platelets >130,000/mm3, calculated creatinine clearance ≥60 ml/minute (Cockcroft \& Gault).
- Adequate cardiac function to tolerate the hydration needed for cisplatin administration.
Who cannot join
- History of CNS metastases unless brain metastases have been resected or successfully treated with stereotactic radiosurgery and the patient has been free from CNS recurrence for 3 months.
- Uveal melanoma primary
- Patients who have had prior anti-CTLA4 monoclonal antibody treatment must have been off treatment for at least 4 months and have signs of progression of disease.
- Frequent vomiting or medical conditions that could interfere with oral medication intake
- Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this therapy.
- History of HIV infection even if on HAART
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- Immunosuppressive drugs
- High dose vitamins and herbs
- Other on-going investigational therapy, concurrent chemotherapy, immunotherapy or radiotherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other investigators have used CVT in melanoma patients and found that tumors got significantly smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of how many patients will respond to CVT. Also they want to test which genes in the tumor are turned on and which are turned off. We hope this will teach us to know in the future which tumors will respond to CVT.
- Conditions
- Melanoma, Skin Cancer
- Being tested
- Cisplatin, Vinblastine, Temozolomide
- Keywords
- skin cancer, CISPLATIN, TEMOZOLOMIDE, VINBLASTINE, 09-017
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin, Vinblastine, TemozolomideDrug
Patients will receive CVT chemotherapy which consists of the following:
Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1.
| Study group | Role | What they receive |
|---|---|---|
| Chemotherapy | Experimental | This is a single institution phase II trial in stage III or IV melanoma patients with measurable disease but no prior cytotoxic chemotherapy and not thought to be curable by surgery.Before starting the chemotherapy, you may need to have a fresh biopsy of your tumor. If you have already had a tumor biopsy that we can use, you may not need another biopsy. Your study doctor will review with you the biopsies you have had. We will try to obtain biopsy material that already exists but if we cannot, you will need another biopsy. Receives: Drug: Cisplatin, Vinblastine, Temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response to CVT Chemotherapy.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MelanomaStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul Chapman, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885534
- Sponsor's protocol ID
- 09-017
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2009
- Last updated
- 6 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT00885534
- Acronym / sponsor ID
- 09-017
- Conditions
- Melanoma, Skin Cancer
- Keywords
- skin cancer, CISPLATIN, TEMOZOLOMIDE, VINBLASTINE, 09-017
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Apr 2009 (estimated)
- Results
- Posted 6 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators want to learn to predict which tumors will respond to CVT chemotherapy. CVT is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other investigators have used CVT in melanoma patients and found that tumors got significantly smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of how many patients will respond to CVT. Also they want to test which genes in the tumor are turned on and which are turned off. We hope this will teach us to know in the future which tumors will respond to CVT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chemotherapy | Experimental | Drug: Cisplatin, Vinblastine, TemozolomideThis is a single institution phase II trial in stage III or IV melanoma patients with measurable disease but no prior cytotoxic chemotherapy and not thought to be curable by surgery.Before starting the chemotherapy, you may need to have a fresh biopsy of your tumor. If you have already had a tumor biopsy that we can use, you may not need another biopsy. Your study doctor will review with you the biopsies you have had. We will try to obtain biopsy material that already exists but if we cannot, you will need another biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years
- Histologic proof of melanoma reviewed and confirmed at MSKCC
- Patients must have stage IV melanoma or recurrent stage IIIb or IIIc melanoma. Patients who are potentially respectable will be eligible.
- Measurable disease (RECIST criteria). Patients must have a tumor amenable to biopsy for oligonucleotide microarray analysis and for immunohistochemistry. A pre-treatment biopsy is required; a fine needle aspirate is not adequate.
- No prior cytotoxic chemotherapy for melanoma. Prior immunotherapy or anti-angiogenic therapy is allowed.
Key exclusion criteria (9 listed)
- History of CNS metastases unless brain metastases have been resected or successfully treated with stereotactic radiosurgery and the patient has been free from CNS recurrence for 3 months.
- Uveal melanoma primary
- Patients who have had prior anti-CTLA4 monoclonal antibody treatment must have been off treatment for at least 4 months and have signs of progression of disease.
- Frequent vomiting or medical conditions that could interfere with oral medication intake
- Serious infection requiring antibiotics, or nonmalignant medical illnesses that are uncontrolled or whose control might be jeopardized by the complications of this 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 |
|---|---|---|
| Cisplatin, Vinblastine, TemozolomidePatients will receive CVT chemotherapy which consists of the following: Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1. | Drug | Chemotherapy |
Primary outcome
Overall Response to CVT Chemotherapy.
Time frame: 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Paul Chapman, MD principal investigator
Memorial Sloan Kettering 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 Cisplatin, Vinblastine, Temozolomide in people with Melanoma and Skin Cancer, run by Memorial Sloan Kettering 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 9 inclusion and 9 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 6 May 2015. 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?
Yes. Results are posted in the registry (first posted 6 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Response to CVT Chemotherapy. (time frame: 2 years). 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 6 May 2015.