Melanoma MetastaticPhase 2NCT01692691
Dacarbazine and Carmustine in Metastatic Melanoma
A Phase 2 study testing Dacarbazine, Carmustine and Neulasta in people with Melanoma Metastatic, run by Western Regional Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether dacarbazine and carmustine at the doses and schedule used in this study will help to increase tumor shrinkage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma Metastatic
- What is being tested?
- Dacarbazine, Carmustine and Neulasta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Oct 2014
- 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
- Patients must have a histologically-proven diagnosis of metastatic malignant melanoma which has progressed on at least one prior systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and estimated survival of at least 3 months.
- Patients must be felt to have recovered from effects of prior cancer therapy, such as past expected leukocyte nadir for chemotherapy (> 2 weeks).
- Absolute granulocyte count of at least 1500/mm3; hemoglobin of at least 9 gm/dl; platelet count of at least 100,000/mm3; bilirubin must be less than 1.5 mg/dl; ALT and AST must be less than 3 times the upper limit of normal; creatinine must be less than or equal to 1.8 mg/dl.
- Women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken.
- Patient consent must be obtained prior to entrance onto study.
- Patients must have no evidence of significant cardiovascular disease including history of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure, uncontrolled angina or cerebrovascular accident.
Who cannot join
- Evidence of significant cardiovascular disease including history of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure, uncontrolled angina, or cerebrovascular accident.
- Prior history of psychiatric disorder that could be exacerbated by or which could preclude completion of this therapy.
- Pregnancy or lactation.
- Prior chemotherapy with carmustine
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Regional Medical Center
Goodyear, Arizona, 85338
About this study
Official title: Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated Metastatic Melanoma
The purpose of this study is to determine whether dacarbazine and carmustine at the doses and schedule used in this study will help to increase tumor shrinkage.
Read the detailed description
In this phase II trial, patients with stage IV melanoma will be treated with dacarbazine and carmustine commonly used in this cancer, but given using a schedule that might theoretically improve on this combination. Patients on this study will be assessed in terms of toxicity, response rate, median duration of response, median time to disease progression, and median survival.
- Conditions
- Melanoma Metastatic
- Being tested
- Dacarbazine, Carmustine, Neulasta
- Keywords
- Melanoma Metastatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DacarbazineDrug
Also called DTIC
Dacarbazine IV - Day 1
CarmustineDrug
Also called BCNU
Carmustine IV- Day 2
NeulastaDrug
Also called pegfilgrastim
Neulasta SC - Day 3
| Study group | Role | What they receive |
|---|---|---|
| Dacarbazine, carmustine, neulasta | Experimental | Dacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3 Receives: Drug: Dacarbazine; Drug: Carmustine; Drug: Neulasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy
Measured: 8 weeks
Secondary outcomes (2)
Response Rate
To determine the response rate after being treated with Dacarbazine Carmustine
Measured: 8 weeks
Median Duration of Response
To determine the median duration of response for patients who received Dacarbazine and Carmustine
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: PI decision
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 Melanoma MetastaticStudies 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jordan Waypa, FNP, Study director, CTCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692691
- Sponsor's protocol ID
- 12-10
- Status last verified
- Mar 2018
- First submitted
- 29 Aug 2012
- Last updated
- 4 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Sequenced Chemotherapy With Dacarbazine and Carmustine With Neulasta® Support in Previously Treated Metastatic Melanoma
- ClinicalTrials.gov ID
- NCT01692691
- Acronym / sponsor ID
- 12-10
- Conditions
- Melanoma Metastatic
- Keywords
- Melanoma Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Western Regional Medical CenterUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Posted 2 Feb 2016
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 determine whether dacarbazine and carmustine at the doses and schedule used in this study will help to increase tumor shrinkage.
Detailed description
In this phase II trial, patients with stage IV melanoma will be treated with dacarbazine and carmustine commonly used in this cancer, but given using a schedule that might theoretically improve on this combination. Patients on this study will be assessed in terms of toxicity, response rate, median duration of response, median time to disease progression, and median survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dacarbazine, carmustine, neulasta | Experimental | Drug: Dacarbazine, Drug: Carmustine, Drug: NeulastaDacarbazine IV - Day 1; Carmustine IV - Day 2; Neulasta SC - Day 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have a histologically-proven diagnosis of metastatic malignant melanoma which has progressed on at least one prior systemic therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 and estimated survival of at least 3 months.
- Patients must be felt to have recovered from effects of prior cancer therapy, such as past expected leukocyte nadir for chemotherapy (> 2 weeks).
- Absolute granulocyte count of at least 1500/mm3; hemoglobin of at least 9 gm/dl; platelet count of at least 100,000/mm3; bilirubin must be less than 1.5 mg/dl; ALT and AST must be less than 3 times the upper limit of normal; creatinine must be less than or equal to 1.8 mg/dl.
- Women of childbearing potential must have a negative pregnancy test and adequate precautions to prevent pregnancy during treatment must be taken.
Key exclusion criteria (4 listed)
- Evidence of significant cardiovascular disease including history of recent (< 6 months) myocardial infarction, uncompensated congestive heart failure, uncontrolled angina, or cerebrovascular accident.
- Prior history of psychiatric disorder that could be exacerbated by or which could preclude completion of this therapy.
- Pregnancy or lactation.
- Prior chemotherapy with carmustine
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 |
|---|---|---|
| DacarbazineAlso: DTICDacarbazine IV - Day 1 | Drug | Dacarbazine, carmustine, neulasta |
| CarmustineAlso: BCNUCarmustine IV- Day 2 | Drug | Dacarbazine, carmustine, neulasta |
| NeulastaAlso: pegfilgrastimNeulasta SC - Day 3 | Drug | Dacarbazine, carmustine, neulasta |
Primary outcome
Progression Free Survival
Time frame: 8 weeks
Progression free survival of patients with Stage IV melanoma who have had disease progression on at least one prior systemic therapy
2 secondary outcomes
Response Rate
Time frame: 8 weeks
Median Duration of Response
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jordan Waypa, FNP study director
CTCA
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 Dacarbazine, Carmustine and Neulasta in people with Melanoma Metastatic, run by Western Regional Medical 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 4 Apr 2018. 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 2 Feb 2016). 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?
Progression Free Survival (time frame: 8 weeks). 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 4 Apr 2018.