- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042952
Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer
A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
I. Determine the activity of imatinib mesylate in patients with progressive, refractory, or recurrent pure testicular seminoma or ovarian germ cell dysgerminoma after cisplatin-based chemotherapy.
II. Determine the toxicity of this drug in this patient population. III. Determine KIT expression and identify mutations in the c-kit gene in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial response or stable disease with normalization of human chorionic gonadotropin may undergo surgical resection of residual lesions at each tumor status assessment. If residual viable germ cell tumor is present in the resected specimen, patients may resume imatinib mesylate. If no viable germ cell tumor is present in the resected specimen, then no further therapy is administered.
Patients are followed every 3 months for 1 year and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 32-38 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60606
- Cancer and Leukemia Group B
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically confirmed pure testicular seminoma or ovarian germ cell dysgerminoma
- Histologic documentation of metastatic/recurrent disease not required
- Alpha-fetoprotein level must be normal, unless abnormal level is explained by other conditions and approved by the study chair
- Clinical stage II or III
Progressive, refractory, or recurrent disease, meeting at least 1 of the following criteria:
- Measurable progressive disease
- Biopsy-proven residual disease
- Persistently elevated or rising B-human chorionic gonadotropin (HCG) titers, defined as at least 2 values above the upper limit of normal (ULN)
Cisplatin-refractory disease without option of potentially curative therapy, meeting 1 of the following criteria:
- Failed high-dose chemotherapy with peripheral blood stem cell transplantation (PBSCT) or autologous bone marrow transplantation (AuBMT)
- Ineligible for or refused PBSCT or AuBMT
- Unlikely to achieve long-term benefit from PBSCT or AuBMT
Current evidence of metastatic disease
Unidimensionally measurable target lesions
- At least 20 mm by conventional techniques (e.g., physical examination for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung)
- At least 10 mm by spiral CT scan or MRI
- If measurable disease is confined to a solitary lesion, then its neoplastic nature must be confirmed by histology
- Ultrasound may not be used to measure tumor lesions that are not easily accessible clinically
Non-measurable/non-target lesions, with HCG at least ULN, including the following:
- Bone lesions
- Pleural or pericardial effusions
- Ascites
- CNS lesions
- Leptomeningeal disease
- Irradiated lesions, unless progression documented after radiotherapy
- Performance status - ECOG 0-2
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL (transfusion allowed)
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- SGOT/SGPT no greater than 2.5 times ULN
- Creatinine no greater than 1.5 times ULN
- No other severe and/or uncontrolled concurrent medical illness
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective barrier contraception during and for 3 months after study participation
- See Disease Characteristics
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- No concurrent chemotherapy
- No concurrent hormonal therapy except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy
- Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) allowed
- No concurrent palliative radiotherapy
- No concurrent grapefruit juice
- No concurrent warfarin for therapeutic anticoagulation (concurrent mini-dose warfarin [1 mg orally per day] as prophylaxis allowed)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (imatinib mesylate and surgical resection)
Patients receive oral imatinib mesylate once daily.
Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients who achieve a partial response or stable disease with normalization of human chorionic gonadotropin may undergo surgical resection of residual lesions at each tumor status assessment.
If residual viable germ cell tumor is present in the resected specimen, patients may resume imatinib mesylate.
If no viable germ cell tumor is present in the resected specimen, then no further therapy is administered.
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Correlative studies
Given orally
Other Names:
Undergo surgical resection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response rate defined as either a complete or partial response using RECIST criteria
Time Frame: Up to 2 years
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Response rate (CR+PR) and exact 95% confidence interval based on the binomial distribution for the response rate will be computed.
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Up to 2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grade 1 or higher toxicities assessed using CTC)version 2
Time Frame: Up to 2 years
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Toxicities will be tabulated.
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Up to 2 years
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Duration of response
Time Frame: From first response (CR or PR) to the date of disease progression or death, assessed up to 2 years
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The Kaplan-Meier product-limit method will be used.
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From first response (CR or PR) to the date of disease progression or death, assessed up to 2 years
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Disease-free survival
Time Frame: From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years
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The Kaplan-Meier product-limit method will be used.
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From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years
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Overall survival
Time Frame: From date of initiation of treatment to date of death due to any cause, assessed up to 2 years
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The Kaplan-Meier product-limit method will be used.
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From date of initiation of treatment to date of death due to any cause, assessed up to 2 years
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Proportion of patients with mutations in the c-KIT gene
Time Frame: Up to 2 years
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The 95% confidence interval will be estimated.
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Up to 2 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher Ryan, Cancer and Leukemia Group B
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Genital Neoplasms, Female
- Endocrine System Diseases
- Disease Attributes
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Genital Neoplasms, Male
- Testicular Diseases
- Neoplasms, Germ Cell and Embryonal
- Testicular Neoplasms
- Recurrence
- Ovarian Neoplasms
- Seminoma
- Germinoma
- Dysgerminoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
Other Study ID Numbers
- NCI-2012-02481
- U10CA031946 (U.S. NIH Grant/Contract)
- CLB-90105
- CDR0000069487 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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