Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies

NCT ID: NCT00038207

Last Updated: 2018-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2005-09-30

Brief 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.

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposomal Vincristine

Group Type: EXPERIMENTAL

Liposomal Vincristine

Intervention Type: DRUG

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

Interventions

Liposomal 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

Intervention Type: DRUG

Other Intervention Names

Vincristine Sulfate Liposome

Eligibility Criteria

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

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inex Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cynthia E. Herzog, MD, BA

Role: PRINCIPAL_INVESTIGATOR

UT MD Anderson Cancer Center

Locations

UT MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

UT MD Anderson Cancer Center website

Other Identifiers

P99-401

Identifier Type: -

Identifier Source: org_study_id