Tasigna Neoadjuvant Gastrointestinal Stromal Tumor (GIST)

NCT01270893 | Withdrawn Phase 2

• 1 other identifier: 2009-0722
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical research study is to learn if Tasigna® (nilotinib) can cause tumor cells to shrink and/or die in patients with GIST who are scheduled for surgery or may be eligible for surgery. The safety of this drug will be studied. Researchers also want to use imaging scans to study the changes in tumor size that may be caused by using nilotinib.

Conditions

Gastrointestinal Cancer

Keywords

Gastrointestinal stromal tumor; GIST; Nilotinib; AMN107; Tasigna

Outcome Measures

Primary Outcomes (1)

• Percent of Apoptotic Tumor Cells Pre- and 7 Days Post Nilotinib Treatment

  Changes assessed by tumor cell apoptosis measured by Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay.

  Pre treatment assessment to 7 days post treatment.

Study Arms (2)

Nilotinib and Surgical Resection

EXPERIMENTAL

Drug: Nilotinib

Nilotinib and Potential Resection

EXPERIMENTAL

Drug: Nilotinib

Interventions

Nilotinib DRUG

400 mg by mouth twice a day for 7 days. Patients on Arm 2 will continue to receive Nilotinib until they have disease progression or are resectable.

Also known as: AMN107, Tasigna

Nilotinib and Potential Resection; Nilotinib and Surgical Resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An informed consent form must be completed before beginning any study procedure. In order to meet the proposed scientific endpoints, a tissue biopsy will be required at entry. The patient has the right to refuse participation in this study. The ease and ability of the biopsy will be an essential component of the selection process.
• Continued from #1- Ease and ability of the biopsy will be determined by the enrolling physician and the physician performing the biopsy. The risks and potential complications of biopsy will be explained to each individual patient, with consideration of tumor location, potential damage to nearby organs, potential effect on the patients' quality of life, and the potential effect on the patients performance status.
• Patients must be greater than or equal to 18 years of age.
• Histologically documented diagnosis of primary, recurrent, locally advanced and/or metastatic GIST for which complete surgical resection (R0 or R1) is planned by a MDACC sarcoma surgeon.
• Immunohistochemical documentation of c-kit expression by the tumor.
• At least one measurable site of disease greater than 1 cm that can be accurately measured in one dimension by plain radiograph, CT, or MRI.
• Performance status 0, 1, or 2 (ECOG)
• Adequate end organ function, defined as the following: total bilirubin \< 1.5 x ULN (Does not apply to patients with isolated hyperbilirubinemia (e.g. Gilbert's disease) grade \<3), ALT and AST \< 2.5 x ULN, creatinine \< 1.5 x ULN, ANC \> 1.5 x 10\^9/L, platelets \> 100 x 10\^9/L, Serum amylase and lipase \</ = 1.5 x ULN, Alkaline Phosphatase \</= 2.5 x ULN
• Patients must have the following laboratory values (WNL = within normal limits at the local institution lab) or corrected to within normal limits with supplements prior to the first dose of study medication: Potassium, Magnesium, Phosphorus, Calcium
• Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Female patients who have been surgically sterilized(ie., tubal ligation) should be considered non- childbearing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
• Written, voluntary informed consent.

You may not qualify if:

• Patient has received any other investigational agents within 28 days of first day of study drug dosing, unless the disease is rapidly progressing.
• Patient is \< 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ. Existence of any other clinically significant malignant disease which requires systemic treatment (chemotherapy or radiation) is not allowed.
• Female patients who are pregnant or breast-feeding.
• Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.
• Patient has a rare hereditary problem of galactose intolerance, severe lactase deficiency or of glucose-galactose malabsorption.
• Patient with electrolyte abnormality (e.g., hypokalemia, hypomagnesemia, hypophosphatemia, hyperkalemia, hypocalcemia, hyponatremia) unless the level can be corrected to normal levels prior to initiating study drug.
• Patient has a known brain metastasis
• Patients with metastasis outside of the peritoneal cavity
• If patients have any signs or symptoms of metastasis, the appropriate workup should occur prior to enrollment (e.g., CT of the head for a patient with CNS symptoms).
• Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis), acute liver disease, acute or chronic pancreatic disease.
• Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
• Patient received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing.
• Patient with prior exposure to sunitinib, nilotinib or imatinib.
• Patient previously received radiotherapy to greater than or equal to 25 % of the bone marrow.
• Patient had a major surgery within 2 weeks prior to study entry.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Novartis: collaborator

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Gastrointestinal Neoplasms; Gastrointestinal Stromal Tumors

Interventions

nilotinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Study Officials

• Jonathan Trent, MD, PHD, BS

  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: January 4, 2011
• First Posted: January 5, 2011
• Study Start: January 1, 2011
• Last Updated: August 2, 2012

Record last verified: 2012-08