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CompletedNCT00038207Updated Oct 31, 2018

Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies

A Phase 2 interventional study of Liposomal Vincristine in Soft Tissue Sarcoma, Lymphoma and Leukemia, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2018-10-31.

Sponsored by M.D. Anderson Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
29
Allocation
Non-randomized
Sex
All
01

Study 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 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.

02

Conditions studied

  • Soft Tissue Sarcoma
  • Lymphoma
  • Leukemia
  • Wilms' Tumor
  • Osteosarcoma

Keywords

  • soft tissue sarcoma
  • Bone sarcomas
03

In context

Sarcoma

1,668 studies on the registry are indexed under Sarcoma; 394 are open to participants now.

This study's enrollment of 29 is below the median of 40 across 1,283 interventional studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 579 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

    1. soft tissue sarcoma
    2. bone sarcoma(CLOSED TO ENTRY AS OF 09/01/02)
    3. Wilms tumor(CLOSED TO ENTRY AS OF 09/01/02)
    4. lymphoma(CLOSED TO ENTRY AS OF 09/01/02)
    5. leukemia(CLOSED TO ENTRY AS OF 09/01/02)
  • 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.

Exclusion criteria

Exclusion criteria:

  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Liposomal Vincristine

    Drug: Liposomal Vincristine

Interventions

  • DrugLiposomal Vincristine

    Vincristine Sulfate Liposome Injection (VSLI) administered via a central venous catheter at 2.0 mg/m2 over 60 minutes every 14 days + 2 days

    Also known as: Vincristine Sulfate Liposome

06

What researchers measure

Primary outcomes

  1. Number of Patients with Response

    Response defined as Complete Response or Partial Response.

    Time frame: 3 Months post initiation of treatment

07

Study locations

1 site
  • UT MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00038207
Lead sponsor
M.D. Anderson Cancer Center
Collaborators
Inex Pharmaceuticals
Responsible party
Sponsor
First posted
May 30, 2002
Start date
Jun 2000
Primary completion
Sep 2004
Completion
Sep 2005
Last update
Oct 31, 2018

Study contacts

Cynthia E. Herzog, MD, BA
principal investigator · UT MD Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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