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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00042952 |
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, refractory, or recurrent stage II or stage III testicular cancer or stage II or stage III ovarian cancer following cisplatin-based chemotherapy.
Condition | Intervention | Phase |
---|---|---|
Ovarian Cancer Testicular Germ Cell Tumor |
Drug: imatinib mesylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma |
Study Start Date: | June 2002 |
OBJECTIVES:
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.
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed pure testicular seminoma or ovarian germ cell dysgerminoma
Progressive, refractory, or recurrent disease, meeting at least 1 of the following criteria:
Cisplatin-refractory disease without option of potentially curative therapy, meeting 1 of the following criteria:
Current evidence of metastatic disease
Unidimensionally measurable target lesions
Non-measurable/non-target lesions, with HCG at least ULN, including the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study Chair: | Christopher W. Ryan, MD | University of Chicago |
Study ID Numbers: | CDR0000069487, CLB-90105 |
Study First Received: | August 5, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00042952 |
Health Authority: | United States: Federal Government |
recurrent malignant testicular germ cell tumor testicular seminoma ovarian dysgerminoma recurrent ovarian germ cell tumor |
stage II malignant testicular germ cell tumor stage III malignant testicular germ cell tumor stage II ovarian germ cell tumor stage III ovarian germ cell tumor |
Ovarian cancer Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Seminoma Endocrine System Diseases Urogenital Neoplasms Testicular Neoplasms Ovarian Diseases |
Recurrence Imatinib Genital Diseases, Female Dysgerminoma Neoplasms, Germ Cell and Embryonal Testicular cancer Endocrinopathy Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Adnexal Diseases |