Metastatic MelanomaPhase 1NCT01005472
Temozolomide and Sunitinib Malate in Treating Patients With Stage III or Stage IV Malignant Melanoma
A Phase 1 study testing sunitinib malate and temozolomide in people with Metastatic Melanoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- sunitinib malate and temozolomide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2008to 17 Jan 2018
- Phase
- Phase 1
- 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
- Histologically confirmed Stage IIIC unresectable cutaneous or mucosal melanoma with measureable disease or stage IV cutaneous, mucosal or ocular melanoma with measureable disease.
- ECOG performance status of 0-2
- age greater than or equal to 18 years
- ANC ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
- Hemoglobin ≥ 10.0 g/dL
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- Creatinine ≤ 2 times upper limit of normal (ULN)
- Total bilirubin ≤ 2 times ULN
- LDH ≤ 5 times ULN
- AST or ALT ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present)
- LVEF ≥ 50% on screening ECHO
- women of childbearing potential must have a negative urine or serum pregnancy test upto 28 days prior to commencement of dosing.
- Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
- Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- before study entry , written informed consent must be obtained. Written informed consent must be obtained from patient prior to performing any study related procedures.
Who cannot join
- pregnant or nursing
- any following within the past 12 months:
- Myocardial infarction
- Severe and/or unstable angina
- Coronary and/or peripheral artery bypass graft
- Symptomatic congestive heart failure
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- Cerebrovascular accident or transient ischemic attack
- Pulmonary embolism
- ongoing cardiac dysrhythmias ≥ grade 2, according to NCI CTCAE v3.0
- prolonged QTc interval on baseline EKG
- uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg despite optimal medical therapy)
- pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- any known clinically uncontrolled infectious disease, including HIV positivity or AIDS-related illness
- severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for study entry
- prior chemotherapy for melanoma, except for chemotherapy given during isolated limb perfusion for stage IIIC disease
- Prior adjuvant immunotherapy and/or immunotherapy for metastatic disease allowed
- prior major surgery, radiotherapy, or immunotherapy within 4 weeks of starting therapy
- treatment with potent CYP3A4 inhibitors 7 days before study dosing
- treatment with potent CYP3A4 inducers 12 days before study dosing
- concurrent treatment on another clinical trial (Concurrent participation on supportive care trials or non-treatment trials (e.g., quality-of-life trials) allowed).
- concurrent chemotherapy, immunotherapy, biological therapy, or investigational drugs
- concurrent drugs with dysrhythmic potential, including any of the following:
- Terfenadine
- Quinidine
- Procainamide
- Disopyramide
- Sotalol
- Probucol
- Bepridil
- Haloperidol
- Risperidone
- Indapamide
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles (UCLA)
Los Angeles, California, 90095
About this study
Official title: A Phase I/II Study of Daily Oral Dosing With Temozolomide and Sunitinib Malate for 6 Weeks of an 8-Week Cycle in Patients With Metastatic and Unresectable Locally-Advanced Malignant Melanoma
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sunitinib malate may kill more tumor cells.
Phase II was never conducted due to toxicity in phase I.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib malate when given together with temozolomide and to see how well they work in treating patients with stage III or stage IV malignant melanoma.
Read the detailed description
OBJECTIVES:
Primary
- Assess the maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide in patients with stage IIIC or IV malignant melanoma. (Phase I)
- Assess the overall safety of this regimen in these patients. (Phase I)
- Determine the response rate in patients treated with this regimen. (Phase II) Phase II was never conducted due to toxicity in phase I.
Secondary
- Determine the response rate in patients treated with this regimen. (Phase I)
- Determine the safety and tolerability of this regimen in these patients. (Phase II)
- Determine the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a phase I, dose-escalation study of sunitinib malate followed by a phase II study.
Patients receive oral sunitinib malate once daily and oral temozolomide once daily on days 1-42. Treatment repeats every 56 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up very 6 months for up to 5 years.
Phase II was never conducted due to toxicity in phase I.
- Conditions
- Metastatic Melanoma
- Being tested
- sunitinib malate, temozolomide
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, metastatic intraocular melanoma, recurrent intraocular melanoma
- Medical subject headings
- Melanoma, Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib malateDrug
temozolomideDrug
| Study group | Role | What they receive |
|---|---|---|
| sunitinib malate, temozolomide | Experimental | Not described Receives: Drug: sunitinib malate; Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide (Phase I)
Measured: 6 weeks
Overall safety
Measured: 5 years
Response rate as assessed by modified RECIST criteria (phase II)
Phase II was never conducted due to toxicity in phase I.
Measured: 5 years
Secondary outcomes (3)
Response rate as assessed by modified RECIST criteria (Phase I)
Measured: 6 weeks
Progression-free survival
Measured: 5 years
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study start1 Dec 2008
- Primary completion17 Jan 2018
- Study completion17 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic MelanomaStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer, Schering-Plough
- Responsible party
- Sponsor
- Investigators
- Bartosz Chmielowski, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005472
- Sponsor's protocol ID
- CDR0000634373
- Other IDs
- UCLA-0711052, SPRI-P05513, PFIZER-GA6181FZ, 10-001406
- Status last verified
- Apr 2018
- First submitted
- 30 Oct 2009
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Daily Oral Dosing With Temozolomide and Sunitinib Malate for 6 Weeks of an 8-Week Cycle in Patients With Metastatic and Unresectable Locally-Advanced Malignant Melanoma
- ClinicalTrials.gov ID
- NCT01005472
- Acronym / sponsor ID
- CDR0000634373
- Conditions
- Metastatic Melanoma
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma, ciliary body and choroid melanoma, medium/large size, extraocular extension melanoma, iris melanoma, metastatic intraocular melanoma, recurrent intraocular melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer, Schering-Plough
- Study start
- 1 Dec 2008 (actual)
- Primary completion
- 17 Jan 2018 (actual)
- Study completion
- 17 Jan 2018 (actual)
- First posted
- 2 Nov 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.
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving temozolomide together with sunitinib malate may kill more tumor cells.
Phase II was never conducted due to toxicity in phase I.
PURPOSE: This phase I/II trial is studying the side effects and best dose of sunitinib malate when given together with temozolomide and to see how well they work in treating patients with stage III or stage IV malignant melanoma.
Detailed description
OBJECTIVES:
Primary
- Assess the maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide in patients with stage IIIC or IV malignant melanoma. (Phase I)
- Assess the overall safety of this regimen in these patients. (Phase I)
- Determine the response rate in patients treated with this regimen. (Phase II) Phase II was never conducted due to toxicity in phase I.
Secondary
- Determine the response rate in patients treated with this regimen. (Phase I)
- Determine the safety and tolerability of this regimen in these patients. (Phase II)
- Determine the progression-free survival of patients treated with this regimen.
- Determine the overall survival of patients treated with this regimen.
OUTLINE: This is a phase I, dose-escalation study of sunitinib malate followed by a phase II study.
Patients receive oral sunitinib malate once daily and oral temozolomide once daily on days 1-42. Treatment repeats every 56 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed up very 6 months for up to 5 years.
Phase II was never conducted due to toxicity in phase I.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sunitinib malate, temozolomide | Experimental | Drug: sunitinib malate, Drug: temozolomide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed Stage IIIC unresectable cutaneous or mucosal melanoma with measureable disease or stage IV cutaneous, mucosal or ocular melanoma with measureable disease.
- ECOG performance status of 0-2
- age greater than or equal to 18 years
- ANC ≥ 1,500/µL
- Platelet count ≥ 100,000/µL
Key exclusion criteria (32 listed)
- pregnant or nursing
- any following within the past 12 months:
- Myocardial infarction
- Severe and/or unstable angina
- Coronary and/or peripheral artery bypass graft
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 |
|---|---|---|
| sunitinib malate | Drug | sunitinib malate, temozolomide |
| temozolomide | Drug | sunitinib malate, temozolomide |
Primary outcome
Maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide (Phase I)
Time frame: 6 weeks
Overall safety
Time frame: 5 years
Response rate as assessed by modified RECIST criteria (phase II)
Time frame: 5 years
Phase II was never conducted due to toxicity in phase I.
3 secondary outcomes
Response rate as assessed by modified RECIST criteria (Phase I)
Time frame: 6 weeks
Progression-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
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 3 Aug 2020.
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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.
Bartosz Chmielowski, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sunitinib malate and temozolomide in people with Metastatic Melanoma, 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?
The sponsor lists 15 inclusion and 32 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 3 Aug 2020. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum tolerated dose of sunitinib malate when administered concurrently with temozolomide (Phase I) (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 3 Aug 2020.