Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Inex Pharmaceuticals
• Treatments: Vincristine

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.