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

A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00453310
Enrollment
10
Registered
2007-03-28
Start date
2007-03-31
Completion date
2008-11-30
Last updated
2015-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extragonadal Germ Cell Tumor, Ovarian Cancer, Teratoma, Testicular Germ Cell Tumor

Keywords

recurrent ovarian germ cell tumor, stage IV ovarian germ cell tumor, ovarian choriocarcinoma, ovarian immature teratoma, ovarian mature teratoma, recurrent malignant testicular germ cell tumor, testicular choriocarcinoma, testicular seminoma, testicular yolk sac tumor, ovarian dysgerminoma, ovarian embryonal carcinoma, ovarian yolk sac tumor, ovarian monodermal and highly specialized teratoma, ovarian polyembryoma, stage III malignant testicular germ cell tumor, ovarian mixed germ cell tumor, testicular choriocarcinoma and embryonal carcinoma, testicular choriocarcinoma and seminoma, testicular choriocarcinoma and teratoma, testicular choriocarcinoma and yolk sac tumor, testicular embryonal carcinoma and seminoma, testicular embryonal carcinoma and teratoma with seminoma, testicular embryonal carcinoma and teratoma, testicular embryonal carcinoma and yolk sac tumor with seminoma, testicular embryonal carcinoma and yolk sac tumor, testicular yolk sac tumor and teratoma with seminoma, testicular yolk sac tumor and teratoma, testicular embryonal carcinoma, recurrent extragonadal non-seminomatous germ cell tumor, recurrent extragonadal seminoma, stage IV extragonadal non-seminomatous germ cell tumor, stage IV extragonadal seminoma, recurrent extragonadal germ cell tumor, testicular immature teratoma, testicular mature teratoma, adult teratoma

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.

Interventions

DRUGsunitinib malate

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Pfizer
CollaboratorINDUSTRY
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment2 years

Countries

United States

Participant flow

Participants by arm

ArmCount
Sunitinib Malate
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) sunitinib malate
10
Total10

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyProgression of Disease10

Baseline characteristics

CharacteristicSunitinib Malate
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
10 Participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
10 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
8 / 10
serious
Total, serious adverse events
1 / 10

Outcome results

Primary

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

Time frame: 2 years

ArmMeasureGroupValue (NUMBER)
Sunitinib MalateConfirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of TreatmentProgression of Disease7 participants
Sunitinib MalateConfirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of TreatmentStable Disease3 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026