NCT00091078

Brief Summary

Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Oblimersen may help imatinib mesylate kill more tumor cells by making tumor cells more sensitive to the drug. This phase II trial is studying how well giving imatinib mesylate together with oblimersen works in treating patients with advanced gastrointestinal stromal tumor that cannot be removed by surgery.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

September 7, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2004

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

10 months

First QC Date

September 7, 2004

Last Update Submit

June 4, 2013

Conditions

Gastrointestinal Stromal Tumor

Outcome Measures

Primary Outcomes (2)

  • Response defined using the Choi criteria

    The design method of Thall, Simon and Estey will be used.

    2 months

  • Toxicity defined as any of the following events: regimen-related death, transaminitis, infection, or leukopenia grade 3 or higher using NCI CTCAE version 3.0

    The design of Thall, Simon and Estey will be used.

    2 months

Secondary Outcomes (2)

  • Disease-free survival

    Up to 4 years

  • Overall survival

    Up to 4 years

Study Arms (1)

Treatment (oblimersen sodium and imatinib mesylate)

EXPERIMENTAL

Patients receive oblimersen IV continuously on days 1-14. Patients also receive oral imatinib mesylate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Biological: oblimersen sodiumDrug: imatinib mesylateOther: laboratory biomarker analysis

Interventions

oblimersen sodiumBIOLOGICAL

Given IV

Also known as: augmerosen, G3139, G3139 bcl-2 antisense oligodeoxynucleotide, Genasense
Treatment (oblimersen sodium and imatinib mesylate)
imatinib mesylateDRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec
Treatment (oblimersen sodium and imatinib mesylate)
laboratory biomarker analysisOTHER

Correlative studies

Treatment (oblimersen sodium and imatinib mesylate)

Eligibility Criteria

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

You may qualify if:

  • A pre-imatinib paraffin block of tumor or 20 unstained slides should be submitted for correlative studies if available
  • All patients must have either "limited" progression on imatinib (arm 1, some but not all tumor foci progressing and are not amenable to local therapy) or "generalized" progression (arm 2, widespread progression of all tumor foci) after adequate therapy with imatinib mesylate (\> or = 400 mg/day for at least 6 weeks)
  • Histologically confirmed diagnosis of Kit-expressing advanced GIST; advanced GIST is defined by patients who have disease that is unresectable; this includes patients with metastatic disease or primary tumors that cannot be safely removed by a sarcoma surgical oncologist
  • Measurable disease by CT; tests used to assess disease must be done within 28 days prior to registration. If a targeted lesion has been previously embolized or irradiated, or if the patient has received imatinib, there must be objective evidence of progression to be considered for response assessment
  • ECOG performance status 0-2
  • At least 4 weeks and recovery from effects of prior therapy (i.e radiation, biotherapy, chemotherapy other than imatinib mesylate, or embolization;) recovery from the effects of prior therapy such that they are less than or equal to grade 1 in severity for non-hematological toxicities excluding nausea and vomiting controlled with standard anti-emetic regimens, alopecia, fatigue, and peripheral edema
  • Absolute neutrophil count (ANC) \>= 1000/mm3
  • Platelets \>= 100,000/mm3
  • Serum creatinine =\< 1.5 x ULN
  • Serum bilirubin =\< 1.5 x ULN
  • Serum SGOT or SGPT =\< 2.5 x ULN if no liver metastases or =\< 5 x ULN if liver metastases are present
  • PT and PTT =\< 1.5 x ULN
  • Understand and sign written informed consent in accordance with institutional and federal guidelines
  • All patients must have progressive disease defined as 1) an increase in unidimensional tumor size of \> or = 10% AND did not meet criteria for PR by CT density, 2) any new lesions, including new tumor nodules in a previous cystic tumor
  • Patients with widespread metastatic and progressive disease will be eligible for this protocol
  • +2 more criteria

You may not qualify if:

  • Significant concurrent medical disease other than cancer including:
  • New York Heart Association class III or IV cardiac problems (e.g., congestive heart failure, acute myocardial infarction within 2 months of study)
  • Uncontrolled chronic renal or liver disease
  • Uncontrolled diabetes
  • Uncontrolled seizure disorder
  • Active uncontrolled infection, e.g., HIV
  • Organ allografts
  • History of second cancer, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 or more years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Interventions

oblimersenImatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Jonathan Trent

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2004

First Posted

September 8, 2004

Study Start

September 1, 2005

Primary Completion

July 1, 2006

Last Updated

June 5, 2013

Record last verified: 2013-06

Locations

US(1)