Phase II Study of Imatinib Mesylate in Patients With Life Threatening Malignant Rare Diseases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

185 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2007-01-31

Brief Summary

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Exploratory study to examine the effect(s) of Imatinib mesylate treatment on life threatening rare diseases with known associations to one or more Imatinib mesylate -sensitive tyrosine kinases, and to identify the contribution of specific protein tyrosine kinases (PTKs) of that specific disease.

Detailed Description

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Conditions

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Life Threatening Diseases

Keywords

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adenocarcinoma leiomyosarcoma angiosarcoma synovial sarcoma myelodysplastic syndrome/HES CMML multiple myeloma embryonal rhabdomyosarcoma endometrial sarcoma adenoid cystic carcinoma fibromatosis ductal invasive breast carcinoma chondrosarcoma pleural tumor brenner tumor ewing sarcoma round cell tumor seminoma thymic carcinoma malignant melanoma fibrosarcoma breast dermatofibrosarcoma protuberans DFSP ovarian stromal tumor osteosarcoma chorioideal melanoma hemangiopericytoma myelofibrosis liposarcoma SCLC small cell lung carcinoma hypereosinophilic syndrome chronic myelo-monocytic leukemia neurofibrosarcoma mesothelioma malignant mesenchymoma malignant schwannoma mast cell leukemia / mastocytosis renal cell carcinoma malignant histocytoma chordoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Imatinib mesylate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients ≥ 15 years of age
* Life threatening disease documented by conventional criteria to be resistant to standard, approved therapy.
* Experimental documentation of functional significance of either Abl, Kit (CD117), or PDGF-R in the relevant target tissue (preferably on a sample taken within 6 weeks of study entry).
* ECOG Performance status of 0, 1, or 2.
* Adequate end organ function defined as: total bilirubin \< 1.5 x ULN, SGOT and SGPT \< 2.5 x UNL (or \< 5 x ULN for patients with hepatic disease), creatinine \< 1.5 x ULN, ANC \> 1.5 x 109/L, platelets \> 100 x 109/L.
* Negative serum or urine pregnancy test for women of child bearing potential (WOCBP) within 7 days of study initiation. Post menopausal women must have experienced amenorrhea for at least 12 months. Male and female patients must use effective birth control methods throughout the study and for up to 3 months after study discontinuation.
* Life expectancy of more than 3 months.
* Written, voluntary, informed consent for retrieval, evaluation and investigational use of tissue samples.

Exclusion Criteria

* Patients who have received any other investigational agent within 28 days of study initiation.
* Patients with another primary malignancy except if other primary malignancy is neither currently clinically significant nor requiring active intervention.
* Patients with Grade III/IV cardiac problems defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study).
* Female patients who are pregnant or breast-feeding.
* Patients who have another severe and/or life threatening medical disease.
* Patients with acute or known chronic liver disease (e.g. chronic active hepatitis, cirrhosis).
* Patients with a known diagnosis of the human immunodeficiency virus ((HIV) infection.
* Patients who have received chemotherapy within 4 weeks (6 weeks allowed for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry.
* Patients who have had major surgery within 2 weeks prior to study entry.
* Patients with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.

Minimum Eligible Age

15 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Heinrich, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

References

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Chugh R, Wathen JK, Maki RG, Benjamin RS, Patel SR, Meyers PA, Priebat DA, Reinke DK, Thomas DG, Keohan ML, Samuels BL, Baker LH. Phase II multicenter trial of imatinib in 10 histologic subtypes of sarcoma using a bayesian hierarchical statistical model. J Clin Oncol. 2009 Jul 1;27(19):3148-53. doi: 10.1200/JCO.2008.20.5054. Epub 2009 May 18.

Reference Type RESULT

PMID: 19451433 (View on PubMed)

Other Identifiers

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CSTI571B2225

Identifier Type: -

Identifier Source: org_study_id