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NCT00453310 · REGISTRY CONDITION SEARCH

Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2015-10-27

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Histologically confirmed seminoma or nonseminoma germ cell tumors (GCT) * Refractory or relapsed disease * Metastatic disease * Progressive disease after prior cisplatin-based chemotherapy AND meets 1 of the following criteria for salvage therapy: * Not a candidate for potentially curative therapy * Received prior high-dose chemotherapy regimens * Declines potentially curative therapy (mediastinal GCT or primary refractory GCT) * Measurable disease\*, defined as 1 of the following: * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * Elevation of alpha-fetoprotein \> 15 ng/mL and/or elevation of human chorionic gonadotropin \> 2.2 mIU/L * NOTE: \*Patients with radiographically measurable disease only must have ≥ 1 site that has not undergone prior irradiation PATIENT CHARACTERISTICS: * Karnofsky performance status 70-100% * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 9.0 g/dL * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * AST and ALT ≤ 2.5 times ULN (unless elevated liver function abnormalities due to underlying malignancy) * LVEF ≥ 50% by MUGA * No grade 3 hemorrhage within the past 4 weeks * None of the following within the past 6 months: * Myocardial infarction * Severe or unstable angina * Coronary or peripheral artery bypass graft * Symptomatic congestive heart failure * Cerebrovascular accident or transient ischemic attack * Pulmonary embolism * No prolonged QTc interval (i.e., QTc \> 450 msec for males and \> 470 msec for females) * No ongoing cardiac dysrhythmias ≥ grade 2 * No uncontrolled hypertension, defined as blood pressure \> 150/100 mm Hg despite optimal therapy * No active infection * No other severe acute or chronic medical or psychiatric condition or laboratory abnormality that would preclude study compliance, according to the study investigator * Not pregnant or nursing * Negative sonogram required to exclude pregnancy * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior sunitinib malate * More than 4 weeks since prior major surgery and recovered * More than 4 weeks since prior radiotherapy and recovered * Concurrent palliative radiotherapy to metastatic lesion(s) allowed provided ≥ 1 measurable lesion has not been irradiated * No concurrent therapeutic doses of warfarin * Low-dose oral warfarin (up to 2 mg daily) for prophylaxis and treatment or heparin products at prophylactic or treatment doses allowed * No other concurrent investigational or approved anticancer therapies, including chemotherapy, biologic response modifiers, hormone therapy, or immunologic-based treatment * Concurrent participation in supportive care or nontreatment trials (e.g., quality-of-life or laboratory analyses) allowed
healthy Volunteers
false
maximum Age
120 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)
    intervention Names
    1. Drug: sunitinib malate
    label
    sunitinib malate
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. sunitinib malate
    name
    sunitinib malate
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
10
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment
    time Frame
    2 years
Full study description
brief Summary
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.
detailed Description
OBJECTIVES: Primary * Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors. Secondary * Determine the safety of this drug in these patients. * Determine the time to tumor response and duration of tumor response in patients treated with this drug. OUTLINE: This is a open-label study. Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed at 28 days and then periodically thereafter.
Source references
references
  1. citation
    Feldman DR, Turkula S, Ginsberg MS, Ishill N, Patil S, Carousso M, Bosl GJ, Motzer RJ. Phase II trial of sunitinib in patients with relapsed or refractory germ cell tumors. Invest New Drugs. 2010 Aug;28(4):523-8. doi: 10.1007/s10637-009-9280-2. Epub 2009 Jun 23.
    pmid
    19547919
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice