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Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies

Phase 2
Not Enrolling
Soft Tissue Sarcoma, Lymphoma, Leukemia, Wilms' Tumor, Osteosarcoma

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Trial Information

Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies

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.

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

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Response

Outcome Description:

Response defined as Complete Response or Partial Response.

Outcome Time Frame:

3 Months post initiation of treatment

Safety Issue:


Principal Investigator

Cynthia E. Herzog, MD, BA

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

June 2000

Completion Date:

September 2005

Related Keywords:

  • Soft Tissue Sarcoma
  • Lymphoma
  • Leukemia
  • Wilms' Tumor
  • Osteosarcoma
  • soft tissue sarcoma
  • Bone sarcomas
  • Leukemia
  • Lymphoma
  • Wilms Tumor
  • Osteosarcoma
  • Sarcoma



UT MD Anderson Cancer Center Houston, Texas  77030