NCT00038207

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2000

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

4.3 years

First QC Date

May 29, 2002

Last Update Submit

October 30, 2018

Conditions

Soft Tissue SarcomaLymphomaLeukemiaWilms' TumorOsteosarcoma

Keywords

soft tissue sarcomaBone sarcomas

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Response

    Response defined as Complete Response or Partial Response.

    3 Months post initiation of treatment

Study Arms (1)

Liposomal Vincristine

EXPERIMENTAL
Drug: Liposomal Vincristine

Interventions

Liposomal VincristineDRUG

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

Also known as: Vincristine Sulfate Liposome
Liposomal Vincristine

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

SarcomaLymphomaLeukemiaWilms TumorOsteosarcomaBone Neoplasms

Interventions

Vincristine

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHematologic DiseasesNeoplasms, Complex and MixedKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasms, Bone TissueNeoplasms, Connective TissueBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Vinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizines

Study Officials

  • Cynthia E. Herzog, MD, BA

    UT MD Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2002

First Posted

May 30, 2002

Study Start

June 1, 2000

Primary Completion

September 1, 2004

Study Completion

September 1, 2005

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations

US(1)