MelanomaPhase 2NCT00673361
Pilot Trial of "Chemo-Switch" Regimen to Treat Advanced Melanoma
A Phase 2 study testing Concurrent decrescendo biochemotherapy regimen and Low-dose Temozolomide plus Sorafenib in people with Melanoma, run by Duke University.
Trial summary
This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma
- What is being tested?
- Concurrent decrescendo biochemotherapy regimen and Low-dose Temozolomide plus Sorafenib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Jan 2009
- 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
- Must have histologically or cytologically confirmed melanoma that is locally advanced or metastatic. Cutaneous, mucosal, ocular, and unknown primary melanoma are all eligible.
- Must have measurable disease, defined by RECIST as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20mm with conventional techniques or >10mm with spiral CT scan.
- May have received prior radiation therapy to one or more non-index lesions (prior radiation to an index lesion is allowable only if progression of the irradiated lesion is demonstrated, with progression defined as an increase of 20% or more in the largest diameter) and/or one prior vaccine therapy for metastatic disease. Prior adjuvant therapy with IFN alpha-2b, vaccine, and/or granulocyte-macrophage colony-stimulating factor (GM-CSF) is permitted. At least 4 weks must have elapsed since the completion of any prior therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients must have normal organ and marrow function as defined below:
- leukocytes >3,000/uL (microliters)
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- absolute neutrophil count >1,500/uL
- platelets >100,000/uL
- total bilirubin <2.0mg/dL
- AST (Aspartate transaminase)(SGOT)/ALT (Alanine transaminase)(SGPT) <2.5 X institutional upper limit of normal
- creatinine <1.8mg/dL
- If >50 years of age with one or more cardiac risk factors, must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation.
- Must be at least 2 weeks out from major surgery and be free of any active infection requiring antibiotics.
- Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Women must demonstrate a negative pregnancy test prior to initiation of protocol therapy.
- Ability to understand and the willingness to sign a written informed consent form.
Who cannot join
- Prior chemotherapy, cytokine therapy (including IL-2 or IFN alpha), or antibody therapy for metastatic disease. Prior vaccine therapy is permitted.
- May not be currently receiving any other antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccine, or investigational agents.
- History of brain metastases.
- Autoimmune disorders that could result in life-threatening complications in the setting of IFN alpha and IL-2 treatment.
- History of sensitivity to E. coli-derived products.
- Concurrent use of corticosteroids or any medical condition likely to require the use of systemic corticosteroids.
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- A seizure disorder currently requiring anti-epileptic medication.
- Uncontrolled intercurrent illness including, but not limited to, hypertension, active infection requiring antibiotic therapy, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Evidence of bleeding diathesis.
- Currently on therapeutic anticoagulation. Prophylactic anticoagulation (such as low-dose warfarin) of venous or arterial access devices is allowed provided the PT, PTT (Partial Thromboplastin Time), and international normalized ratio (INR) are normal.
About this study
Official title: Phase II Pilot Trial of "Chemo-Switch" Regimen of Biochemotherapy Followed by Daily Low-Dose Temozolomide Plus Sorafenib in Advanced Melanoma
This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide plus sorafenib have on melanoma.
- Conditions
- Melanoma
- Being tested
- Concurrent decrescendo biochemotherapy regimen, Low-dose Temozolomide plus Sorafenib
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent decrescendo biochemotherapy regimenDrug
- Temozolomide: 200mg/m^2, daily, PO, days 1-4
- Vinblastine: 1.5mg/m^2, daily, IV, days 1-4
- Cisplatin: 20mg/m^2, daily IV, days 1-4
- IL (interleukin)-2: - 18 milli-International unit (MIU)/m^2, IVCI (intravenous continual infusion), day 1
- 9 MIU/m^2, IVCI, day 2
- 4.5 MIU/m^2, IVCI, days 3 \& 4
- Interferon (IFN) alpha: 5 MIU/m^2, daily, SC (subcutaneously), days 1-5
- 5-day inpatient regimen, to be repeated every 21 days
Low-dose Temozolomide plus SorafenibDrug
Temozolomide: 75mg/m^2, PO, QD (quaque die), 6 weeks on/2 weeks off Sorafenib: 400mg, PO, BID, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| "Chemo-Switch" Regimen | Experimental | Not described Receives: Drug: Concurrent decrescendo biochemotherapy regimen; Drug: Low-dose Temozolomide plus Sorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
Terminated study before accrual goal, no data analysis
Measured: 3 weeks, 6 weeks, 16 weeks, & 24 weeks
Secondary outcomes (1)
Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Measured: post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMar 2007
- Primary completionJan 2009
- Study completionJan 2009
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 Duke UniversityThe 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Michael A Morse, M.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673361
- Sponsor's protocol ID
- 9361
- Other IDs
- SR05-888
- Status last verified
- Dec 2012
- First submitted
- 4 May 2008
- Last updated
- 13 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Trial of "Chemo-Switch" Regimen of Biochemotherapy Followed by Daily Low-Dose Temozolomide Plus Sorafenib in Advanced Melanoma
- ClinicalTrials.gov ID
- NCT00673361
- Acronym / sponsor ID
- 9361
- Conditions
- Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Mar 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 7 May 2008 (estimated)
- Results
- Posted 26 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is testing the "chemo-switch" strategy in melanoma, using biochemotherapy initially to shrink tumors and then switching to daily low-dose chemotherapy (temozolomide) together with sorafenib. The purpose of this study is to find out what effects (good and bad) biochemotherapy followed by temozolomide plus sorafenib have on melanoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| "Chemo-Switch" Regimen | Experimental | Drug: Concurrent decrescendo biochemotherapy regimen, Drug: Low-dose Temozolomide plus Sorafenib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Must have histologically or cytologically confirmed melanoma that is locally advanced or metastatic. Cutaneous, mucosal, ocular, and unknown primary melanoma are all eligible.
- Must have measurable disease, defined by RECIST as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20mm with conventional techniques or >10mm with spiral CT scan.
- May have received prior radiation therapy to one or more non-index lesions (prior radiation to an index lesion is allowable only if progression of the irradiated lesion is demonstrated, with progression defined as an increase of 20% or more in the largest diameter) and/or one prior vaccine therapy for metastatic disease. Prior adjuvant therapy with IFN alpha-2b, vaccine, and/or granulocyte-macrophage colony-stimulating factor (GM-CSF) is permitted. At least 4 weks must have elapsed since the completion of any prior therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients must have normal organ and marrow function as defined below:
Key exclusion criteria (10 listed)
- Prior chemotherapy, cytokine therapy (including IL-2 or IFN alpha), or antibody therapy for metastatic disease. Prior vaccine therapy is permitted.
- May not be currently receiving any other antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccine, or investigational agents.
- History of brain metastases.
- Autoimmune disorders that could result in life-threatening complications in the setting of IFN alpha and IL-2 treatment.
- History of sensitivity to E. coli-derived products.
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 |
|---|---|---|
| Concurrent decrescendo biochemotherapy regimen* Temozolomide: 200mg/m^2, daily, PO, days 1-4 * Vinblastine: 1.5mg/m^2, daily, IV, days 1-4 * Cisplatin: 20mg/m^2, daily IV, days 1-4 * IL (interleukin)-2: - 18 milli-International unit (MIU)/m^2, IVCI (intravenous continual infusion), day 1 * 9 MIU/m^2, IVCI, day 2 * 4.5 MIU/m^2, IVCI, days 3 \& 4 * Interferon (IFN) alpha: 5 MIU/m^2, daily, SC (subcutaneously), days 1-5 * 5-day inpatient regimen, to be repeated every 21 days | Drug | "Chemo-Switch" Regimen |
| Low-dose Temozolomide plus SorafenibTemozolomide: 75mg/m^2, PO, QD (quaque die), 6 weeks on/2 weeks off Sorafenib: 400mg, PO, BID, 8 weeks | Drug | "Chemo-Switch" Regimen |
Primary outcome
Progression Free Survival (PFS)
Time frame: 3 weeks, 6 weeks, 16 weeks, & 24 weeks
Terminated study before accrual goal, no data analysis
1 secondary outcome
Response Rate as Determined by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Time frame: post-cycle 1 of low-dose temozolomide plus sorafenib, then every 3 months for up to 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
- 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.
Michael A Morse, M.D. principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Concurrent decrescendo biochemotherapy regimen and Low-dose Temozolomide plus Sorafenib in people with Melanoma, run by Duke University.
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 15 inclusion and 10 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 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 26 Apr 2013). 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 (PFS) (time frame: 3 weeks, 6 weeks, 16 weeks, & 24 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 13 Jan 2016.