Recurrent Ovarian Germ Cell Tumor Clinical Trial
Official title:
A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma
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
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01846520 -
Family Caregiver Palliative Care Intervention in Supporting Caregivers of Patients With Stage II-IV Gastrointestinal, Gynecologic, Urologic and Lung Cancers
|
N/A | |
| Terminated |
NCT01233505 -
Veliparib, Oxaliplatin, and Capecitabine in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01764789 -
Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer
|
N/A | |
| Completed |
NCT01037790 -
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
|
Phase 2 | |
| Completed |
NCT00467051 -
Combination Chemotherapy in Treating Young Patients With Recurrent or Resistant Malignant Germ Cell Tumors
|
Phase 2 | |
| Completed |
NCT02283658 -
Everolimus and Letrozole in Treating Patients With Recurrent Hormone Receptor Positive Ovarian, Fallopian Tube, or Primary Peritoneal Cavity Cancer
|
Phase 2 | |
| Completed |
NCT01652794 -
Carboplatin, Gemcitabine Hydrochloride, and Stereotactic Body Radiation Therapy in Gynecological Cancer
|
Phase 1 | |
| Withdrawn |
NCT01558778 -
Mechanical Stimulation in Preventing Bone Density Loss in Patients Undergoing Donor Stem Cell Transplant
|
N/A | |
| Completed |
NCT01131234 -
Gamma-Secretase Inhibitor RO4929097 and Cediranib Maleate in Treating Patients With Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01126346 -
Quality of Life and Survivorship Care in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
|
N/A | |
| Completed |
NCT01079832 -
Stereotactic Radiosurgery Using CyberKnife in Treating Women With Advanced or Recurrent Gynecological Malignancies
|
Phase 2 | |
| Terminated |
NCT00087191 -
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
|
N/A | |
| Completed |
NCT01155258 -
Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors
|
Phase 1 | |
| Completed |
NCT00957905 -
Alvocidib and Oxaliplatin With or Without Fluorouracil and Leucovorin Calcium in Treating Patients With Relapsed or Refractory Germ Cell Tumors
|
Phase 2 | |
| Completed |
NCT00408681 -
Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease After Donor Stem Cell Transplant
|
N/A | |
| Completed |
NCT00228358 -
Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient's Own T Cells in the Laboratory in Treating Patients With HER-2/Neu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2/Neu Vaccine
|
Phase 1 | |
| Completed |
NCT00897442 -
Collecting Tumor Samples From Patients With Gynecological Tumors
|
N/A | |
| Terminated |
NCT01159067 -
Deferasirox for Treating Patients Who Have Undergone Allogeneic Stem Cell Transplant and Have Iron Overload
|
Phase 2 | |
| Active, not recruiting |
NCT00638898 -
Busulfan, Melphalan, Topotecan Hydrochloride, and a Stem Cell Transplant in Treating Patients With Newly Diagnosed or Relapsed Solid Tumor
|
Phase 1 | |
| Suspended |
NCT02122185 -
Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
|
Phase 2 |