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| Sponsors and Collaborators: |
Southwest Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00036842 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating men who have germ cell cancer that has not responded to previous treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Extragonadal Germ Cell Tumor Testicular Germ Cell Tumor |
Drug: arsenic trioxide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies |
| Study Start Date: | April 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive arsenic trioxide IV over 1-2 hours on days 1-5. Courses repeat every 28 days for up to 3 years in the absence of disease progression or unacceptable toxicity. Patients who achieve a confirmed complete or partial response receive up to 3 additional courses past response.
Patients are followed every 2 months for 3 years or until disease progression.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 10-40 months.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Refractory disease, defined by at least 1 of the following criteria:
Disease progression during or within 4 weeks of cisplatin-containing regimen
At least 1 of the following:
Unidimensionally measurable disease
PATIENT CHARACTERISTICS:
Age:
Sex:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 94 Study Locations| Study Chair: | Tomasz M. Beer, MD | Oregon Health and Science University |
More Information
| Study ID Numbers: | CDR0000069328, SWOG-S0207 |
| Study First Received: | May 13, 2002 |
| Last Updated: | April 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00036842 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent malignant testicular germ cell tumor extragonadal germ cell tumor |
|
Testicular Cancer Neoplasms, Germ Cell and Embryonal Malignant Germ Cell Tumor Arsenic trioxide |
Testicular Neoplasms Recurrence Extragonadal Germ Cell Tumor |
|
Neoplasms Neoplasms by Histologic Type Antineoplastic Agents Therapeutic Uses |
Neoplasms, Germ Cell and Embryonal Arsenic trioxide Pharmacologic Actions |