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

September 24, 2015 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 116 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)
Pfizer

Investigators

  • Principal Investigator: Robert J. Motzer, MD, Memorial Sloan Kettering Cancer Center
  • Principal Investigator: Dean F. Bajorin, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria

March 27, 2007

First Posted (Estimate)

March 28, 2007

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

September 24, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-004
  • P30CA008748 (U.S. NIH Grant/Contract)
  • MSKCC-07004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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