Malignant MelanomaPhase 1NCT00145041
Pharmacokinetic Study of Liposomal Vincristine in Patients With Malignant Melanoma & Hepatic Dysfunction
A Phase 1 study testing Vincristine Sulfate Liposomes Injection in people with Malignant Melanoma, run by Acrotech Biopharma Inc. at 1 site in United States.
Trial summary
The purpose of this study is to see how vincristine, when placed in an oil droplet called a liposome (VSLI), is absorbed, distributed (moved around) and excreted from the the body (pharmacokinetics). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Melanoma
- What is being tested?
- Vincristine Sulfate Liposomes Injection
- Type of treatment
- 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
- Feb 2005to Nov 2007
- Phase
- Phase 1
- 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 histologically confirmed, surgically nonresectable Stage III or IV metastatic cutaneous, mucosal, or choroidal melanoma, and not be eligible for a treatment protocol of a higher priority.
- Patients must have secondary tumor involvement of the liver confirmed by CT scan and a bilirubin level of 1.6-3.0 mg/dL (National Cancer Institute, Common Terminology Criteria for Adverse Events Grade 2) (MD Anderson Cancer Center normal range is 0-1.0 mg/dL).
- Patients must have bidimensionally measurable disease.
- Patients with nonchoroidal melanoma must have received prior chemotherapy for metastatic disease with cytotoxic or biological drugs. Patients with choroidal melanoma may or may not have received prior chemotherapy for metastatic disease with cytotoxic or biological drugs.
- Patients must have a Performance Status of 0, 1, 2, or 3 (Zubrod Scale).
- Patients must have recovered from the adverse effects of prior chemotherapy (including cytotoxic agents and biological response modifiers), and/or irradiation therapy.
Show all 10Show fewer
- Patients must have an absolute neutrophil count ≥1.0 x 10*9/L and a platelet count of ≥100 x 10*9/L.
- Patients must have adequate renal function demonstrated by a creatinine level of ≤2.0 mg/dL.
- Patients must have a life expectancy of >8 weeks.
- Patients must provide a signed informed consent document indicating that they are aware of the investigational nature of this study in keeping with the policies of the hospital.
Who cannot join
- Patients treated with radiotherapy, chemotherapy, immunotherapy, vaccine treatment and/or alternative anticancer treatments (including investigational drugs) within 3 weeks prior to study enrollment.
- Patients treated with hepatic chemo-embolization within 4 weeks prior to study enrollment.
- Patients with severe hepatic impairment demonstrated by plasma ammonia levels >105 mMol/L or serum albumin <2.0 g/dL or serum bilirubin >3.0 mg/dL.
- Patients with serious intercurrent illness.
- Patients who have had major surgery within 4 weeks of enrollment.
- Patients with advanced symptomatic central nervous system (CNS) involvement by melanoma and those on phenytoin or requiring steroids for brain metastases, spinal cord compression, or meningeal "carcinomatosis".Patients with asymptomatic and stable metastatic CNS disease can be enrolled.
Show all 13Show fewer
- Patients receiving treatment with phenytoin and/or corticosteroids within 1 week of enrollment. Patients must remain off of these medications for the duration of the treatment phase of the study.
- Patients with a history of neurological disorders unrelated to chemotherapy (including familial neurological diseases and acquired demyelinating disorders).
- Patients with Grade 3 or greater sensory, motor or autonomic neuropathy at screening from any cause.
- Patients receiving treatment with drugs known to inhibit or induce hepatic drug metabolism by cytochrome P450-3A4 isoenzymes and/or P-glycoprotein within 1 week of study enrollment. Patients must remain off of these drugs until the collection of the Cycle 4 pretreatment PK sample.
- Patients with past or current history of liver parenchymal or hepatobiliary disease unrelated to cancer (including but not limited to conditions such as liver cirrhosis, acute/chronic hepatitis, ascending cholangitis, etc).
- Patients who are pregnant or lactating. Females of childbearing potential must have a negative urine or blood pregnancy test at screening. Both men and women must be practicing an adequate method of birth control for the duration of the study. Acceptable methods of birth control include use of an intrauterine device (IUD), oral contraceptive pills, implanted, transdermal, or injected contraceptives, barrier methods with spermicide, and abstinence.
- Patients who are unable to return for follow up re-evaluation and assessment of response to VSLI.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: An Evaluation of the Pharmacokinetic Profile of VSLI (Vincristine Sulfate Liposome Injection, 0.16 mg/mL) in Patients With Malignant Melanoma and Hepatic Dysfunction Secondary to Metastases
The purpose of this study is to see how vincristine, when placed in an oil droplet called a liposome (VSLI), is absorbed, distributed (moved around) and excreted from the the body (pharmacokinetics). This study will also assess the safety of VSLI and to see if VSLI will slow the growth or shrink tumors in patients with metastatic melanoma that has resulted in liver impairment, and who have relapsed after previous therapies.
Read the detailed description
OBJECTIVES:
Primary: To assess the pharmacokinetics of VSLI administered intravenously to patients with malignant melanoma and hepatic dysfunction secondary to metastases.
Secondary: To assess the safety and antitumor activity of VSLI in this population.
- Conditions
- Malignant Melanoma
- Being tested
- Vincristine Sulfate Liposomes Injection
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vincristine Sulfate Liposomes InjectionDrug
Also called Marqibo
Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| VSLI | Experimental | Single armed study; all subjects received VSLI Receives: Drug: Vincristine Sulfate Liposomes Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
T 1/2
The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour every 2 weeks (one cycle) to three male and four female subjects with malignant melanoma and hepatic dysfunction secondary to metastases were measured.
Measured: cycle 1 day 1
Clearance
The pharmacokinetic profile of VCR on Day 1 of Cycle 1 Cl is mL/h/m2
Measured: Day 1 of Cycle 1
Volume of Distribution
The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour
Measured: cycle 1 day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionSep 2007
- Study completionNov 2007
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 Malignant 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acrotech Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Agop Bedikian, MD, Principal investigator, MD Anderson Cancer Center, Dept of Melanoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145041
- Sponsor's protocol ID
- VSLI-12-HEPHARM
- Status last verified
- Dec 2019
- First submitted
- 1 Sep 2005
- Last updated
- 12 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of the Pharmacokinetic Profile of VSLI (Vincristine Sulfate Liposome Injection, 0.16 mg/mL) in Patients With Malignant Melanoma and Hepatic Dysfunction Secondary to Metastases
- ClinicalTrials.gov ID
- NCT00145041
- Acronym / sponsor ID
- VSLI-12-HEPHARM
- Conditions
- Malignant Melanoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Acrotech Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Primary completion
- Sep 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 5 Sep 2005 (estimated)
- Results
- Posted 5 Jan 2012
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 see how vincristine, when placed in an oil droplet called a liposome (VSLI), is absorbed, distributed (moved around) and excreted from the the body (pharmacokinetics). This study will also assess the safety of VSLI and to see if VSLI will slow the growth or shrink tumors in patients with metastatic melanoma that has resulted in liver impairment, and who have relapsed after previous therapies.
Detailed description
OBJECTIVES:
Primary: To assess the pharmacokinetics of VSLI administered intravenously to patients with malignant melanoma and hepatic dysfunction secondary to metastases.
Secondary: To assess the safety and antitumor activity of VSLI in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VSLI | Experimental | Drug: Vincristine Sulfate Liposomes InjectionSingle armed study; all subjects received VSLI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have histologically confirmed, surgically nonresectable Stage III or IV metastatic cutaneous, mucosal, or choroidal melanoma, and not be eligible for a treatment protocol of a higher priority.
- Patients must have secondary tumor involvement of the liver confirmed by CT scan and a bilirubin level of 1.6-3.0 mg/dL (National Cancer Institute, Common Terminology Criteria for Adverse Events Grade 2) (MD Anderson Cancer Center normal range is 0-1.0 mg/dL).
- Patients must have bidimensionally measurable disease.
- Patients with nonchoroidal melanoma must have received prior chemotherapy for metastatic disease with cytotoxic or biological drugs. Patients with choroidal melanoma may or may not have received prior chemotherapy for metastatic disease with cytotoxic or biological drugs.
- Patients must have a Performance Status of 0, 1, 2, or 3 (Zubrod Scale).
Key exclusion criteria (13 listed)
- Patients treated with radiotherapy, chemotherapy, immunotherapy, vaccine treatment and/or alternative anticancer treatments (including investigational drugs) within 3 weeks prior to study enrollment.
- Patients treated with hepatic chemo-embolization within 4 weeks prior to study enrollment.
- Patients with severe hepatic impairment demonstrated by plasma ammonia levels >105 mMol/L or serum albumin <2.0 g/dL or serum bilirubin >3.0 mg/dL.
- Patients with serious intercurrent illness.
- Patients who have had major surgery within 4 weeks of enrollment.
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 |
|---|---|---|
| Vincristine Sulfate Liposomes InjectionAlso: MarqiboMarqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks. | Drug | VSLI |
Primary outcome
T 1/2
Time frame: cycle 1 day 1
The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour every 2 weeks (one cycle) to three male and four female subjects with malignant melanoma and hepatic dysfunction secondary to metastases were measured.
Clearance
Time frame: Day 1 of Cycle 1
The pharmacokinetic profile of VCR on Day 1 of Cycle 1 Cl is mL/h/m2
Volume of Distribution
Time frame: cycle 1 day 1
The PK profiles of total plasma VCR following a single intravenous infusion at a target dose of 1.0 mg/m2 for approximately 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical trial information from M.D. Anderson Cancer Center's websiteLink provided by the sponsor.
Related trials for Malignant Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Agop Bedikian, MD principal investigator
MD Anderson Cancer Center, Dept of Melanoma
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 Vincristine Sulfate Liposomes Injection in people with Malignant Melanoma, run by Acrotech Biopharma Inc. 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 10 inclusion and 13 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 12 Dec 2019. 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?
Yes. Results are posted in the registry (first posted 5 Jan 2012). 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?
T 1/2 (time frame: cycle 1 day 1). 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 12 Dec 2019.