TerminatedNCT00585221Updated Feb 10, 2017Results posted

Study of Imatinib and Peginterferon α-2b in Gastrointestinal Stromal Tumor (GIST) Patients

A Phase 2 interventional study of Peginterferon-alpha 2b (PegIFNa2b); and Imatinib in Gastrointestinal Stromal Tumors, Cancer Brain and Solid Tumors, sponsored by University of Utah. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-10.

Sponsored by University of Utah · Phase 2, Interventional, and Treatment

Why this study was terminated

PI terminated at the recommendation of DSMC \& IRB

Phase: Phase 2
Study type: Interventional
Enrollment: 8
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

Imatinib (IM) has dramatically improved survival of gastrointestinal stromal tumors (GIST). However, most patients become resistant to IM in less than two years. This clinical trial combines targeted therapy (IM) with immunotherapy (peginterferon α-2b). Hypothesis: Apoptosis/necrosis of imatinib-sensitive GIST releases GIST-specific antigens in vivo while Peginterferon α-2b fulfills the role of cytokine signal (danger signal), this combination can induce effective innate and adaptive anti-GIST immunity, which can eradicate imatinib-resistant clones and GIST stem cells via recognition of common antigens shared with imatinib-sensitive GIST, leading to improved response rate and remission duration.

Conditions studied

Gastrointestinal Stromal Tumors
Cancer Brain
Solid Tumors

Browse trials for

Keywords

Gastrointestinal stromal tumors
Imatinib
Peginterferon α-2b
Immunotherapy
Targeted therapy

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 8 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Utah is the lead sponsor of 969 studies on the registry; 178 are open to participants now.

Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Patients must be >18 years old.
Patients must have histologic evidence of GIST (Gastrointestinal Stromal Tumors).
If genotyping was not done, a paraffin block or 7 unstained slides or biopsy unstained slides is required for genotyping within one week of enrollment.
Stage I, II, and III patients are eligible if the primary tumor is 6 centimeter or larger. All stage IV (4) metastatic or recurrent GIST patients who are imatinib-naïve are eligible. For stage IV patients who had initial good response to imatinib and stopped imatinib for 10 months or longer. GIST patients who received imatinib as "adjuvant" treatment in the past, later developed a recurrence are eligible only if the DFS is > 6 months after completion of adjuvant imatinib.
Patients must have a Zubrod Performance Status of 0-1 or Karnofsky Performance Status >70%.
Patients must have a life expectancy of more than twelve months.
Patients must have negative serology tests for HIV (Human immunodeficiency virus). Hepatitis B, Hepatitis C, and ANA (antinuclear antibodies) titer have to be within 2 times of upper limit of normal within 28 days of enrollment. Patients must have no clinical rheumatoid arthritis (RA). RA criteria are as follows: 1) morning stiffness in and around joints lasting at least 1 hour before maximal improvement; 2) soft tissue swelling (arthritis) of 3 or more joint areas observed by a physician; 3) swelling (arthritis) of the proximal interphalangeal, metacarpophalangeal, or wrist joints; 4) symmetric swelling (arthritis); 5) rheumatoid nodules; 6) the presence of rheumatoid factor; and 7) radiographic erosions and/or periarticular osteopenia in hand and/or wrist joints.
Criteria 1 through 4 must have been present for at least 6 weeks. RA is defined by the presence of 4 or more criteria. Patients must have normal thyroid function tests (1.5 times of upper and lower normal limit) including TSH (Thyroid-stimulating Hormone), and T4 (Thyroxine) within 4 weeks of enrollment.
Patients must have adequate liver function as evidenced by the following: total bilirubin, and AST (aspartate aminotransferase) \< 2 times of institutional upper limit of normal assessed within 2 weeks of enrollment. If patient has extensive liver metastasis which is the main cause of abnormal liver function, this requirement does not apply. The Principal Investigator can use his or her clinical judgment.
Patients must have serum creatinine \<2 miligrams/deciliter within 2 weeks of enrollment.
Patients must have WBC (white blood cells) > 3x109 /L, absolute neutrophil count (ANC) > 1.5 x 109 /L platelet count > 125 x 109 /L, hemoglobin > 11 within 2 weeks of enrollment.
Patients must have PT (prothrombin time), PTT (partial thromboplastin time) and INR (international normalized ratio) \< institutional upper limit of normal within 4 weeks of enrollment.
Patients must have no history of malignancy other than atypical melanocytic hyperplasia, basal or squamous skin cancer or any in situ cancer, lobular carcinoma of the breast in situ, cervical cancer in situ, Clark I melanoma in situ or have been continuously disease free for 5 years prior to enrollment.
Patients may not have received chemotherapy within 30 days prior to enrollment.
Patients must have a negative serum pregnancy test if female of childbearing potential.
Patients must agree to use an accepted and effective method of contraception while on Pegintron and for a period of 18 months after completing or discontinuing Pegintron.
Patients may not have autoimmune disorder, or immunodeficiency.
Patients may not have undergone splenectomy or gastrectomy for any reason. Total gastrectomy usually results in poor tolerance to the recommended dose of Imatinib.
Patients cannot require antihistamines, non-steroidal anti-inflammatory drugs, or corticosteroids.
Patients may not have active ischemic heart disease or cerebrovascular disease, congestive heart failure (New York Heart Association class III or IV), or angina requiring ongoing medications. EKG (Electrocardiography) may not show acute ischemic changes or acute heart rhythm changes.
Patients cannot show a history of Central Nervous System demyelination, inflammatory disease or hereditary or acquired peripheral neuropathy greater than Grade 2.
Patients cannot have an ongoing psychiatric disorder, surgical condition, or medical condition requiring a treatment regimen that may interfere with the completion of this trial or the evaluation of safety and efficacy of the study compound. For any questions, please contact the study Principal Investigator.
Patients cannot be taking coumadin, lovenox or heparin for metallic heart valve or hypercoagulability.
Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
In the opinion of the Principal Investigator the patient is eligible and a good candidate for this study.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 8 participants (actual)

Study arms

Experimental
All patients
All participants enrolled in the study.
Drug: Peginterferon-alpha 2b (PegIFNa2b); · Drug: Imatinib

Interventions

DrugPeginterferon-alpha 2b (PegIFNa2b);
Treatment include PegIFNa2b high dose (3 mcg/kg/wk) X 4 doses and low dose (1.5 mcg/kg/wk) X 18 doses, followed by surgical evaluation to render pt disease free if possible.
Also known as: Trade name: Peg-Intron
DrugImatinib
Continue imatinib until progression.
Also known as: Trade name: gleevec

What researchers measure

Primary outcomes

Decrease in Tumor Size.
Response rate is measured by PET-CT scan (a decrease in standardized uptake value (SUV) by 25%), Response Evaluation Criteria in Solid Tumors (RECIST), and Choi criteria (10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced CT, computed tomography, scan).
Time frame: 18 months
Time to Progression (TTP).
Time frame: two years

Results

Posted Nov 21, 2012

Participant flow

Participant flow — Overall Study
Milestone	All Patients
Started	8
Completed	0
Not completed	8
Withdrew: Protocol violation	8

Outcome measures

PrimaryDecrease in Tumor Size.

Response rate is measured by PET-CT scan (a decrease in standardized uptake value (SUV) by 25%), Response Evaluation Criteria in Solid Tumors (RECIST), and Choi criteria (10% decrease in tumor size or a 15% decrease in tumor density on contrast-enhanced CT, computed tomography, scan).

Time frame:: 18 months

No measurements were reported for this outcome.

PrimaryTime to Progression (TTP).

Time frame:: two years

No measurements were reported for this outcome.

Adverse events

Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
All Enrolled	—	—	—

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Group 1
<=18 years	0
Between 18 and 65 years	4
>=65 years	4

Age, Continuous
Age, Continuous(years)	Group 1
Mean	64.875 ± 17.97

Gender
Gender(Participants)	Group 1
Female	3
Male	5

Region of Enrollment
Region of Enrollment(participants)	Group 1
United States	8

Study locations

1 site

University of Utah
Salt Lake City, Utah 84112, United States

References and documents

Publications

Chen LL, Chen X, Choi H, Sang H, Chen LC, Zhang H, Gouw L, Andtbacka RH, Chan BK, Rodesch CK, Jimenez A, Cano P, Jones KA, Oyedeji CO, Martins T, Hill HR, Schumacher J, Willmore C, Scaife CL, Ward JH, Morton K, Randall RL, Lazar AJ, Patel S, Trent JC, Frazier ML, Lin P, Jensen P, Benjamin RS. Exploiting antitumor immunity to overcome relapse and improve remission duration. Cancer Immunol Immunother. 2012 Jul;61(7):1113-24. doi: 10.1007/s00262-011-1185-1. Epub 2011 Dec 24. PubMed 22198309 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00585221
Lead sponsor: University of Utah
Collaborators: Schering-Plough
Responsible party: Sponsor
First posted: Jan 3, 2008
Start date: Jul 2007
Primary completion: Jul 2009
Completion: Jul 2009
Results posted: Nov 21, 2012
Last update: Feb 10, 2017

Study contacts

Lei Chen, MD

principal investigator · University of Utah

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

University of Utah

Start the discussion