Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00453310
Other study ID # 07-004
Secondary ID P30CA008748MSKCC
Status Completed
Phase Phase 2
First received March 27, 2007
Last updated September 24, 2015
Start date March 2007
Est. completion date November 2008

Study information

Verified date September 2015
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 120 Years
Eligibility 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
sunitinib malate


Locations

Country Name City State
United States Memorial Sloan-Kettering Cancer Center New York New York

Sponsors (3)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center National Cancer Institute (NCI), Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment 2 years No
See also
  Status Clinical Trial Phase
Completed NCT02526017 - Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers Phase 1
Withdrawn NCT05201001 - APX005M in Patients With Recurrent Ovarian Cancer Phase 2
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Not yet recruiting NCT06376253 - A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers Phase 1
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Recruiting NCT03412877 - Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Recruiting NCT05156892 - Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer Phase 1
Suspended NCT02432378 - Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines Phase 1/Phase 2
Recruiting NCT04533763 - Living WELL: A Web-Based Program for Ovarian Cancer Survivors N/A
Active, not recruiting NCT03371693 - Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer Phase 3
Withdrawn NCT03032614 - Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients Phase 2
Completed NCT02019524 - Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients Phase 1
Completed NCT01936363 - Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer Phase 2
Terminated NCT00788125 - Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT05059522 - Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing Phase 3
Active, not recruiting NCT04383210 - Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors Phase 2
Terminated NCT04586335 - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors. Phase 1
Terminated NCT03146663 - NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer Phase 2