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Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
This study has been terminated.
First Received: May 29, 2002   Last Updated: November 14, 2005   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038207
  Purpose

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.


Condition Intervention Phase
Soft Tissue Sarcoma
Lymphoma
Leukemia
Wilms' Tumor
Osteosarcoma
Drug: Liposomal Vincristine
Phase II

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Soft Tissue Sarcoma Wilms' Tumor
Drug Information available for: Vincristine Vincristine sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Official Title: Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies

Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 100
Study Start Date: June 2000
Estimated Study Completion Date: September 2005
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038207

Locations
United States, Texas
M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
  More Information

No publications provided

Study ID Numbers: P99-401
Study First Received: May 29, 2002
Last Updated: November 14, 2005
ClinicalTrials.gov Identifier: NCT00038207     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
soft tissue sarcoma
Bone sarcomas

Study placed in the following topic categories:
Urinary Tract Neoplasm
Urogenital Neoplasms
Urologic Neoplasms
Leukemia
Neoplasms, Connective and Soft Tissue
Soft Tissue Sarcomas
Renal Cancer
Urologic Diseases
Kidney Neoplasms
Wilms' Tumor
Wilms Tumor
Osteogenic Sarcoma
Kidney Diseases
Lymphoma
Kidney Cancer
Immunoproliferative Disorders
Osteosarcoma
Vincristine
Antimitotic Agents
Lymphatic Diseases
Malignant Mesenchymal Tumor
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Tubulin Modulators
Sarcoma
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Urogenital Neoplasms
Urologic Neoplasms
Leukemia
Neoplasms, Connective and Soft Tissue
Neoplasms by Site
Urologic Diseases
Kidney Neoplasms
Therapeutic Uses
Wilms Tumor
Kidney Diseases
Lymphoma
Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Mitosis Modulators
Osteosarcoma
Vincristine
Antimitotic Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Neoplastic Syndromes, Hereditary
Neoplasms, Bone Tissue
Genetic Diseases, Inborn
Tubulin Modulators
Sarcoma
Neoplasms, Connective Tissue
Lymphoproliferative Disorders

ClinicalTrials.gov processed this record on May 07, 2009