TumorsPhase 1NCT00364676
Study of Vinorelbine Liposomes Injection for Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease
A Phase 1 study testing VLI in people with Tumors and Hodgkins Disease, run by Spectrum Pharmaceuticals, Inc at 3 sites in 2 countries.
Trial summary
This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumors, Hodgkins Disease, Non-Hodgkins Lymphoma
- What is being tested?
- VLI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jul 2006to Aug 2015
- 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 solid tumor refractory to standard therapy or for which no standard therapy is known to exist, or relapsed and/or refractory non-Hodgkin's lymphoma or Hodgkin's disease
- Adequate hematologic, hepatic and renal functions as defined by laboratory tests.
- At least 18 years of age.
- Have a life expectancy of at least 12 weeks.
- Patients must give written informed consent.
- ECOG or Zubrod performance status of 0, 1, or 2.
Who cannot join
- Primary tumors of central nervous system (CNS). Symptomatic brain metastases (unless patient is stable without requirement of steroids and/or antiseizure medications for at least 3 months) or leptomeningeal tumor involvement.
- Prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas and mitomycin C).
- Planned concurrent systemic therapy and/or radiotherapy drug study treatment.
- Use of investigational drugs, biologics or devices within 28 days prior to study treatment or planned use during the course of the study.
- Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
- Prophylactic hematologic growth factors administered less than or equal to 2 weeks prior to start of therapy with VLI (excluding darbepoetin alfa, epoetin alfa).
- Female patients who are pregnant or lactating.
- Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Cancer Therapy and Research Center
San Antonio, Texas, 78229
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Canada1 site
McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit
Montreal, Quebec, H3T 1E2
About this study
Official title: A Phase 1 Study of Vinorelbine Liposomes Injection (VLI) for Treatment in Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease
This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease.
Read the detailed description
The objectives of this study are:
- To assess the safety and tolerability of treatment with VLI.
- To determine the maximum tolerated dose (MTD) of VLI.
- To characterize the pharmacokinetic (PK) profile of VLI.
- To explore preliminary tumor response of VLI.
- Conditions
- Tumors, Hodgkins Disease, Non-Hodgkins Lymphoma
- Being tested
- VLI
- Keywords
- Vinorelbine, solid tumors, Hodgkins, Non hodgkins, Lymphoma, Advanced solid tumors
- Medical subject headings
- Neoplasms, Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLIDrug
Patients are dosed on Day 1 and Day 8 of a 21-day cycle.
VLIDrug
Patients are dosed on Day 1 of a 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients are dosed on Day 1 and Day 8 of a 21-day cycle. Receives: Drug: VLI |
| 2 | Experimental | Patients are dosed on Day 1 of a 21-day cycle. Receives: Drug: VLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of VLI.
Measured: 21 Days
Secondary outcomes (1)
To determine the maximum tolerated dose (MTD)
Measured: 21 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spectrum Pharmaceuticals, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Sarantopoulos, MD, Principal investigator, Cancer Therapy and Research Center, TexasGerald Batist, MD, Principal investigator, McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research UnitAnthony W. Tolcher, MD, Principal investigator, South Texas Accelerated Research Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364676
- Sponsor's protocol ID
- HBS501
- Status last verified
- Sep 2015
- First submitted
- 14 Aug 2006
- Last updated
- 22 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Vinorelbine Liposomes Injection (VLI) for Treatment in Patients With Advanced Solid Tumors, Non-Hodgkin's Lymphoma or Hodgkin's Disease
- ClinicalTrials.gov ID
- NCT00364676
- Acronym / sponsor ID
- HBS501
- Conditions
- Tumors, Hodgkins Disease, Non-Hodgkins Lymphoma
- Keywords
- Vinorelbine, solid tumors, Hodgkins, Non hodgkins, Lymphoma, Advanced solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Spectrum Pharmaceuticals, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 16 Aug 2006 (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.
This Phase 1 study will determine the safety, tolerability, and pharmacokinetics of vinorelbine liposomes injection (VLI) in patients with advanced solid tumors, non-Hodgkin's lymphoma, or Hodgkin's disease.
Detailed description
The objectives of this study are:
- To assess the safety and tolerability of treatment with VLI.
- To determine the maximum tolerated dose (MTD) of VLI.
- To characterize the pharmacokinetic (PK) profile of VLI.
- To explore preliminary tumor response of VLI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: VLIPatients are dosed on Day 1 and Day 8 of a 21-day cycle. |
| 2 | Experimental | Drug: VLIPatients are dosed on Day 1 of a 21-day cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed solid tumor refractory to standard therapy or for which no standard therapy is known to exist, or relapsed and/or refractory non-Hodgkin's lymphoma or Hodgkin's disease
- Adequate hematologic, hepatic and renal functions as defined by laboratory tests.
- At least 18 years of age.
- Have a life expectancy of at least 12 weeks.
- Patients must give written informed consent.
Key exclusion criteria (8 listed)
- Primary tumors of central nervous system (CNS). Symptomatic brain metastases (unless patient is stable without requirement of steroids and/or antiseizure medications for at least 3 months) or leptomeningeal tumor involvement.
- Prior chemotherapy or radiotherapy within 4 weeks prior to study entry (6 weeks for nitrosoureas and mitomycin C).
- Planned concurrent systemic therapy and/or radiotherapy drug study treatment.
- Use of investigational drugs, biologics or devices within 28 days prior to study treatment or planned use during the course of the study.
- Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
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 |
|---|---|---|
| VLIPatients are dosed on Day 1 and Day 8 of a 21-day cycle. | Drug | 1 |
| VLIPatients are dosed on Day 1 of a 21-day cycle. | Drug | 2 |
Primary outcome
Evaluate the safety and tolerability of VLI.
Time frame: 21 Days
1 secondary outcome
To determine the maximum tolerated dose (MTD)
Time frame: 21 Days
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 22 Sep 2015.
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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.
John Sarantopoulos, MD principal investigator
Cancer Therapy and Research Center, Texas
Gerald Batist, MD principal investigator
McGill Centre for Translational Research in Cancer-Jewish General Hospital Clinical Research Unit
Anthony W. Tolcher, MD principal investigator
South Texas Accelerated Research Therapeutics
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VLI in people with Tumors and Hodgkins Disease, run by Spectrum Pharmaceuticals, Inc at 3 sites in 2 countries.
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 6 inclusion and 8 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 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. 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?
Evaluate the safety and tolerability of VLI. (time frame: 21 Days). 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 22 Sep 2015.