Clinical trial · Interventional
Arsenic Trioxide in Treating Men With Germ Cell Cancer
Phase II Study Of Arsenic Trioxide In Patients With Refractory Germ Cell Malignancies
NCT00036842CI-TRIAL-00010959completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extragonadal Germ Cell Tumor | Extragonadal Germ Cell Tumor | ONTOLOGY_EXACT | 0.98 |
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| arsenic trioxide | Drug | Arsenic Trioxide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 16 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed testicular or extragonadal germ cell cancer
* Refractory disease, defined by at least 1 of the following criteria:
* Disease progression during or within 4 weeks of cisplatin-containing regimen
* Progression is defined as the appearance of new or progression of known locally advanced or metastatic disease or a rise in tumor markers (beta-human chorionic gonadotropin (beta-HCG) or alpha fetoprotein (AFP)) by at least 50% relative to the nadir
* When the only evidence of germ cell progression or recurrence before study entry is the appearance of a new lesion in the absence of tumor marker elevation, a biopsy is required to confirm the diagnosis
* Disease recurrence after at least 2 chemotherapy regimens, one of which includes high-dose therapy (chemotherapy with stem cell support)
* Disease recurrence after at least 2 chemotherapy regimens and not eligible for high-dose therapy
* At least 1 of the following:
* Unidimensionally measurable disease
* Soft tissue, irradiated within the past 2 months, is not considered measurable
* Elevated beta-HCG (more than 20 mIU/mL)
* AFP greater than 2 times upper limit of normal
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Sex:
* Male
Performance status:
* Zubrod 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* WBC at least 3,000/mm\^3
Hepatic:
* Bilirubin less than 2.5 times upper limit of normal (ULN)
* SGOT less than 5 times ULN
* Alkaline phosphatase less than 5 times ULN
Renal:
* Creatinine no greater than 2.5 times ULN OR
* Creatinine clearance at least 40 mL/min
* Potassium normal
* Magnesium normal
* No renal dialysis
Cardiovascular:
* No prior torsades de pointes-type ventricular arrhythmia
* No prolonged QT interval (greater than 450 msec) on ECG in presence of normal potassium and magnesium
Other:
* Fertile patients must use effective contraception
* No active serious infection not controlled by antibiotics
* No known hypersensitivity to arsenic
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or stage I or II disease in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
* More than 28 days since prior cytotoxic agents
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* At least 28 days since prior radiotherapy and recovered
Surgery:
* Not specified
Other:
* More than 28 days since prior experimental agents
* No concurrent or planned drugs known to prolong the QT intervalReferences
Publications (1)
- RESULTBeer TM, Tangen CM, Nichols CR, Margolin KA, Dreicer R, Stephenson WT, Quinn DI, Raghavan D, Crawford ED. Southwest Oncology Group phase II study of arsenic trioxide in patients with refractory germ cell malignancies. Cancer. 2006 Jun 15;106(12):2624-9. doi: 10.1002/cncr.21925. PMID 16688776