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

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ClinicalTrials.gov Identifier: NCT00453310
Recruitment Status : Completed
First Posted : March 28, 2007
Results First Posted : October 27, 2015
Last Update Posted : October 27, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Pfizer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.


Condition or disease Intervention/treatment Phase
Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor Drug: sunitinib malate Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors
Study Start Date : March 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008


Arm Intervention/treatment
Experimental: 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)
Drug: sunitinib malate



Primary Outcome Measures :
  1. Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453310


Locations
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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Pfizer
Investigators
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Principal Investigator: Dean F. Bajorin, MD Memorial Sloan Kettering Cancer Center
Principal Investigator: Robert J. Motzer, MD Memorial Sloan Kettering Cancer Center

Publications of Results:
Feldman DR, Ginsberg MS, Turkula S, et al.: Phase II trial of sunitinib in patients with relapsed or refractory germ cell tumors (GCT). [Abstract] 2009 Genitourinary Cancers Symposium, Feb 26-28, 2009, Orlando, Florida. A-236, 2009.

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00453310     History of Changes
Other Study ID Numbers: 07-004
P30CA008748 ( U.S. NIH Grant/Contract )
MSKCC-07004
First Posted: March 28, 2007    Key Record Dates
Results First Posted: October 27, 2015
Last Update Posted: October 27, 2015
Last Verified: September 2015
Keywords provided by Memorial Sloan Kettering Cancer Center:
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
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Teratoma
Testicular Neoplasms
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Genital Neoplasms, Male
Genital Diseases, Male
Testicular Diseases
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action