Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer

Stopped early · Phase 2

Conditions studied: Ovarian Dysgerminoma, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Ovarian Germ Cell Tumor, Stage II Malignant Testicular Germ Cell Tumor, Stage II Ovarian Germ Cell Tumor, Stage III Malignant Testicular Germ Cell Tumor, Stage III Ovarian Germ Cell Tumor, Testicular Seminoma

In brief

Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. 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

Key facts

Study ID

NCT00042952

Run by

National Cancer Institute (NCI)

People needed

32

Starts

2002-06-01

Last updated by the study team

2013-01-17

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Cancer and Leukemia Group B — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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