NCT00251797

Brief Summary

The study will try to answer these questions:

  1. 1.What is the highest dose of thalidomide brain cancer patients can receive safely in combination with irinotecan?
  2. 2.How well does this combination work to shrink brain tumors, and how long do responses to treatment last?
  3. 3.What side effects does the combination of drugs cause?
  4. 4.How does treatment affect patients' quality of life (how they feel and what activities they are able to do)?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 2000

Longer than P75 for phase_1

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

March 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

January 7, 2010

Status Verified

October 1, 2008

Enrollment Period

6.3 years

First QC Date

November 8, 2005

Last Update Submit

January 6, 2010

Conditions

Brain and Nervous SystemCancer

Keywords

Phase IBrain cancerRecurrent CNS tumors

Outcome Measures

Primary Outcomes (1)

  • Tolerable dosage of thalidomide in combination with irinotecan

    Unacceptable toxicities

Secondary Outcomes (1)

  • Tumor response. For this study, the definition of response will include complete response, partial response and stable disease. Duration of tumor response. uality of life while on treatment

    unacceptable toxicities

Interventions

IrinotecanDRUG

Irinotecan: 300 to 350 mg/m2 mixing with 250 cc. Dextrose injection. IV infusion over 90 minutes D1 and repeat every 21 days

Also known as: Camptosar
ThalidomideDRUG

Thalidomide 50 mg capsule starting from 4 tablets per day Oral D 3 to D 19 of each cycle

Also known as: Thalomid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven high grade astrocytomas, glioblastoma multiforme, anaplastic astrocytoma, anaplastic oligodendroglioma, mixed oligodendroglioma.
  • Subjects are allowed to have definitive surgery and/or radiation treatment to their tumors.
  • Subjects are allowed to have previous chemotherapy for their tumors.
  • Subjects who previous diagnosed to have a low grade lesion need a second biopsy to show transformation into a high grade histology.
  • Subjects need to have radiographic or biopsy proven recurrent disease.
  • ECORT performance status 2 or lower. See appendix I.
  • Baseline laboratory values within 30 days of study entry: hemoglobin 10 gm/dl; absolute neutrophil count 1,500 cells/ml; platelet counts 100,000 cells/ml; SGOT/AST, SGPT/ALT, alkaline phosphatase, LDH 3high normal limit; total bilirubin 2.0 mg/dl.
  • Ability to provide written informed consent.
  • Age \> 18 years.
  • Female patients of childbearing potential must have a documented negative serum pregnancy test within 14 days of study entry.
  • All subjects must agree to use an effective method of contraception for the duration of treatment if engaged in sexual activity where conception is possible, as specified in the STEP program for thalidomide.

You may not qualify if:

  • Therapy with any investigational drug (other than drugs available on treatment IND and used for FDA-sanctioned indications) and/or any chemotherapy regimen within 28 days of study entry.
  • Prior therapy with either irinotecan or thalidomide.
  • Oxygen saturation 90% on room air.
  • Cardiac insufficiency at New York Heart Association status 2 or greater.
  • Other active malignancies except basal or squamous cell carcinoma of the skin or in situ cervical and breast lesions.
  • History of neuropsychiatric disorder or altered mental status which prevent informed consent or compliance with protocol requirement.
  • Known hypersensitivity or allergic reaction to study drug.
  • Women at any stage of pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Neurologic ManifestationsNeoplasmsBrain NeoplasmsCentral Nervous System Neoplasms

Interventions

IrinotecanThalidomide

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNervous System NeoplasmsNeoplasms by SiteBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic CompoundsPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Dennie Jones, MD

    University of New Mexico

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 10, 2005

Study Start

March 1, 2000

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

January 7, 2010

Record last verified: 2008-10

Locations

US(1)