Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies - Tabular View

Tracking Information
First Received Date ^ICMJE	May 29, 2002
Last Updated Date	November 14, 2005
Start Date ^ICMJE	June 2000
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00038207 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
Official Title ^ICMJE	Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
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
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Safety/Efficacy Study
Condition ^ICMJE	Soft Tissue Sarcoma Lymphoma Leukemia Wilms' Tumor Osteosarcoma
Intervention ^ICMJE	Drug: Liposomal Vincristine
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	100
Completion Date	September 2005
Primary Completion Date
Eligibility Criteria ^ICMJE	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). soft tissue sarcoma bone sarcoma(CLOSED TO ENTRY AS OF 09/01/02) Wilms tumor(CLOSED TO ENTRY AS OF 09/01/02) lymphoma(CLOSED TO ENTRY AS OF 09/01/02) 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.
Gender	Both
Ages
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00038207
Responsible Party
Study ID Numbers ^ICMJE	P99-401
Study Sponsor ^ICMJE	M.D. Anderson Cancer Center
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	M.D. Anderson Cancer Center
Verification Date	November 2005
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP