Soft Tissue SarcomaPhase 2NCT00038207
Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
A Phase 2 study testing Liposomal Vincristine in people with Soft Tissue Sarcoma and Lymphoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if treatment with the drug liposomal vincristine can shrink or slow the growth of the patient's cancer. The safety of this drug will also be studied. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Sarcoma, Lymphoma, Leukemia
- What is being tested?
- Liposomal Vincristine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2000to Sep 2005
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with relapsed malignancies in the following strata: (As of 09/01/02, the soft tissue sarcoma strata will remain open for new patient accrual. Strata listed in b, c, d, e will be closed to entry).
- soft tissue sarcoma
- bone sarcoma(CLOSED TO ENTRY AS OF 09/01/02)
- Wilms tumor(CLOSED TO ENTRY AS OF 09/01/02)
- lymphoma(CLOSED TO ENTRY AS OF 09/01/02)
- leukemia(CLOSED TO ENTRY AS OF 09/01/02)
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- Performance status: Zubrod less than 3. Patients with long standing limited mobility requiring the use of a wheelchair will be considered ambulatory for the purpose of this protocol.
- Bidimensionally measurable disease radiologically.
- No anti-cancer treatment within the past 3 weeks.
- ANC greater than or equal to 500; platelets greater than or equal to 50,000; bilirubin less than or equal to 1.5 mg/dl; SGPT less than or equal to 4 x upper normal limit; creatinine less than or equal to 2 x normal. Patients with bone marrow infiltrative disease may be entered irrespective of ANC or platelets.
- Patients may be enrolled after BMT or PSCT if they meet all the above eligibility criteria.
Who cannot join
- HIV positive.
- Serious intercurrent illness, active infections, or second cancer except basal cell carcinoma of the skin or cervical carcinoma in situ.
- Eligible for treatment of a higher priority.
- Pregnancy.
- Grade 3 or 4 sensory or motor dysfunction due to prior vinca alkaloids.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
The goal of this clinical research study is to learn if treatment with the drug liposomal vincristine can shrink or slow the growth of the patient's cancer. The safety of this drug will also be studied.
Read the detailed description
Before and during the treatment patients will have exams done. These may include blood tests, urine tests, bone marrow tests, tests of the central nervous system, x-rays, or MRI/CT test. These are needed to measure the patient's clinical condition and progress. A physical exam and blood tests (about 2 teaspoons) will be repeated at least one time weekly.
Since Liposomal Vincristine may prevent the body from making and/or keeping new blood cells, prior to treatment patients will also have a Human Immunodeficiency Virus (AIDS virus) test, a blood test to detect the presence of antibodies to the AIDS virus. A separate informed consent will be given to be signed, in order to obtain permission for this test. Female patients may also be required to have a urine pregnancy test before treatment may begin, as it is not known how the drug may affect the unborn child.
Patients will receive liposomal vincristine through a central venous catheter (a plastic tube usually inserted under the collar bone) over one hour, once every 14 days, + 2 days. Patient's will also be given the drug docusate by the day liposomal vincristine is started. This is done to try to prevent constipation as a side effect.
All patients who show a continued response or stable disease without major side effects may continue to receive liposomal vincristine for up to 24 months. Patients with solid tumors and lymphoma will have X-rays performed every 8 weeks to follow the progression of their tumor. Patients with leukemia will have a bone marrow aspirate and biopsy done after the first and second months of treatment, and then every 8 weeks.
This is an investigational study. The FDA has authorized the use of the study drug in research. Up to 60 patients will take part in this study. Up to 30 patients will be enrolled at UTMDACC.
- Conditions
- Soft Tissue Sarcoma, Lymphoma, Leukemia, Wilms' Tumor, Osteosarcoma
- Being tested
- Liposomal Vincristine
- Keywords
- soft tissue sarcoma, Bone sarcomas
- Medical subject headings
- Sarcoma, Lymphoma, Leukemia, Wilms Tumor, Osteosarcoma, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal VincristineDrug
Also called Vincristine Sulfate Liposome
Vincristine Sulfate Liposome Injection (VSLI) administered via a central venous catheter at 2.0 mg/m2 over 60 minutes every 14 days + 2 days
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Vincristine | Experimental | Not described Receives: Drug: Liposomal Vincristine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Response
Response defined as Complete Response or Partial Response.
Measured: 3 Months post initiation of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2002 (estimated)
- Study startJun 2000
- Primary completionSep 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Inex Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Cynthia E. Herzog, MD, BA, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00038207
- Sponsor's protocol ID
- P99-401
- Status last verified
- Oct 2018
- First submitted
- 29 May 2002
- Last updated
- 31 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
- ClinicalTrials.gov ID
- NCT00038207
- Acronym / sponsor ID
- P99-401
- Conditions
- Soft Tissue Sarcoma, Lymphoma, Leukemia, Wilms' Tumor, Osteosarcoma
- Keywords
- soft tissue sarcoma, Bone sarcomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Inex Pharmaceuticals
- Study start
- Jun 2000
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 30 May 2002 (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.
The goal of this clinical research study is to learn if treatment with the drug liposomal vincristine can shrink or slow the growth of the patient's cancer. The safety of this drug will also be studied.
Detailed description
Before and during the treatment patients will have exams done. These may include blood tests, urine tests, bone marrow tests, tests of the central nervous system, x-rays, or MRI/CT test. These are needed to measure the patient's clinical condition and progress. A physical exam and blood tests (about 2 teaspoons) will be repeated at least one time weekly.
Since Liposomal Vincristine may prevent the body from making and/or keeping new blood cells, prior to treatment patients will also have a Human Immunodeficiency Virus (AIDS virus) test, a blood test to detect the presence of antibodies to the AIDS virus. A separate informed consent will be given to be signed, in order to obtain permission for this test. Female patients may also be required to have a urine pregnancy test before treatment may begin, as it is not known how the drug may affect the unborn child.
Patients will receive liposomal vincristine through a central venous catheter (a plastic tube usually inserted under the collar bone) over one hour, once every 14 days, + 2 days. Patient's will also be given the drug docusate by the day liposomal vincristine is started. This is done to try to prevent constipation as a side effect.
All patients who show a continued response or stable disease without major side effects may continue to receive liposomal vincristine for up to 24 months. Patients with solid tumors and lymphoma will have X-rays performed every 8 weeks to follow the progression of their tumor. Patients with leukemia will have a bone marrow aspirate and biopsy done after the first and second months of treatment, and then every 8 weeks.
This is an investigational study. The FDA has authorized the use of the study drug in research. Up to 60 patients will take part in this study. Up to 30 patients will be enrolled at UTMDACC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liposomal Vincristine | Experimental | Drug: Liposomal Vincristine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with relapsed malignancies in the following strata: (As of 09/01/02, the soft tissue sarcoma strata will remain open for new patient accrual. Strata listed in b, c, d, e will be closed to entry).
- Performance status: Zubrod less than 3. Patients with long standing limited mobility requiring the use of a wheelchair will be considered ambulatory for the purpose of this protocol.
- Bidimensionally measurable disease radiologically.
- No anti-cancer treatment within the past 3 weeks.
- ANC greater than or equal to 500; platelets greater than or equal to 50,000; bilirubin less than or equal to 1.5 mg/dl; SGPT less than or equal to 4 x upper normal limit; creatinine less than or equal to 2 x normal. Patients with bone marrow infiltrative disease may be entered irrespective of ANC or platelets.
Key exclusion criteria (5 listed)
- HIV positive.
- Serious intercurrent illness, active infections, or second cancer except basal cell carcinoma of the skin or cervical carcinoma in situ.
- Eligible for treatment of a higher priority.
- Pregnancy.
- Grade 3 or 4 sensory or motor dysfunction due to prior vinca alkaloids.
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 |
|---|---|---|
| Liposomal VincristineAlso: Vincristine Sulfate LiposomeVincristine Sulfate Liposome Injection (VSLI) administered via a central venous catheter at 2.0 mg/m2 over 60 minutes every 14 days + 2 days | Drug | Liposomal Vincristine |
Primary outcome
Number of Patients with Response
Time frame: 3 Months post initiation of treatment
Response defined as Complete Response or Partial Response.
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 31 Oct 2018.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Cynthia E. Herzog, MD, BA principal investigator
UT MD Anderson Cancer Center
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 Liposomal Vincristine in people with Soft Tissue Sarcoma and Lymphoma, run by M.D. Anderson 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 11 inclusion and 5 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 31 Oct 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?
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?
Number of Patients with Response (time frame: 3 Months post initiation of treatment). 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 31 Oct 2018.