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Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer

This study has been terminated.
(Administratively complete.)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00042952
First received: August 5, 2002
Last updated: January 15, 2013
Last verified: January 2013
  Purpose

Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have progressive, refractory, or recurrent stage II or stage III testicular cancer or stage II or stage III ovarian cancer following cisplatin-based chemotherapy


Condition Intervention Phase
Ovarian Dysgerminoma
Recurrent Malignant Testicular Germ Cell Tumor
Recurrent Ovarian Germ Cell Tumor
Stage II Malignant Testicular Germ Cell Tumor
Stage II Ovarian Germ Cell Tumor
Stage III Malignant Testicular Germ Cell Tumor
Stage III Ovarian Germ Cell Tumor
Testicular Seminoma
Drug: imatinib mesylate
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate defined as either a complete or partial response using RECIST criteria [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Response rate (CR+PR) and exact 95% confidence interval based on the binomial distribution for the response rate will be computed.


Secondary Outcome Measures:
  • Grade 1 or higher toxicities assessed using CTC)version 2 [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Toxicities will be tabulated.

  • Duration of response [ Time Frame: From first response (CR or PR) to the date of disease progression or death, assessed up to 2 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier product-limit method will be used.

  • Disease-free survival [ Time Frame: From the date of initiation of treatment to date of progression or death due to any cause, whichever occurs first, assessed up to 2 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier product-limit method will be used.

  • Overall survival [ Time Frame: From date of initiation of treatment to date of death due to any cause, assessed up to 2 years ] [ Designated as safety issue: No ]
    The Kaplan-Meier product-limit method will be used.

  • Proportion of patients with mutations in the c-KIT gene [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    The 95% confidence interval will be estimated.


Enrollment: 32
Study Start Date: June 2002
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (imatinib mesylate and surgical resection)
Patients receive oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial response or stable disease with normalization of human chorionic gonadotropin may undergo surgical resection of residual lesions at each tumor status assessment. If residual viable germ cell tumor is present in the resected specimen, patients may resume imatinib mesylate. If no viable germ cell tumor is present in the resected specimen, then no further therapy is administered.
Drug: imatinib mesylate
Given orally
Other Names:
  • CGP 57148
  • Gleevec
  • Glivec
Procedure: therapeutic conventional surgery
Undergo surgical resection
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

OBJECTIVES:

I. Determine the activity of imatinib mesylate in patients with progressive, refractory, or recurrent pure testicular seminoma or ovarian germ cell dysgerminoma after cisplatin-based chemotherapy.

II. Determine the toxicity of this drug in this patient population. III. Determine KIT expression and identify mutations in the c-kit gene in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial response or stable disease with normalization of human chorionic gonadotropin may undergo surgical resection of residual lesions at each tumor status assessment. If residual viable germ cell tumor is present in the resected specimen, patients may resume imatinib mesylate. If no viable germ cell tumor is present in the resected specimen, then no further therapy is administered.

Patients are followed every 3 months for 1 year and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 32-38 months.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed pure testicular seminoma or ovarian germ cell dysgerminoma

    • Histologic documentation of metastatic/recurrent disease not required
  • Alpha-fetoprotein level must be normal, unless abnormal level is explained by other conditions and approved by the study chair
  • Clinical stage II or III
  • Progressive, refractory, or recurrent disease, meeting at least 1 of the following criteria:

    • Measurable progressive disease
    • Biopsy-proven residual disease
    • Persistently elevated or rising B-human chorionic gonadotropin (HCG) titers, defined as at least 2 values above the upper limit of normal (ULN)
  • Cisplatin-refractory disease without option of potentially curative therapy, meeting 1 of the following criteria:

    • Failed high-dose chemotherapy with peripheral blood stem cell transplantation (PBSCT) or autologous bone marrow transplantation (AuBMT)
    • Ineligible for or refused PBSCT or AuBMT
    • Unlikely to achieve long-term benefit from PBSCT or AuBMT
  • Current evidence of metastatic disease

    • Unidimensionally measurable target lesions

      • At least 20 mm by conventional techniques (e.g., physical examination for clinically palpable lymph nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions surrounded by aerated lung)
      • At least 10 mm by spiral CT scan or MRI
      • If measurable disease is confined to a solitary lesion, then its neoplastic nature must be confirmed by histology
      • Ultrasound may not be used to measure tumor lesions that are not easily accessible clinically
  • Non-measurable/non-target lesions, with HCG at least ULN, including the following:

    • Bone lesions
    • Pleural or pericardial effusions
    • Ascites
    • CNS lesions
    • Leptomeningeal disease
    • Irradiated lesions, unless progression documented after radiotherapy
  • Performance status - ECOG 0-2
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT no greater than 2.5 times ULN
  • Creatinine no greater than 1.5 times ULN
  • No other severe and/or uncontrolled concurrent medical illness
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 3 months after study participation
  • See Disease Characteristics
  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy
  • No concurrent hormonal therapy except steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • Prior radiotherapy to a symptomatic lesion or one that may produce disability (e.g., unstable femur) allowed
  • No concurrent palliative radiotherapy
  • No concurrent grapefruit juice
  • No concurrent warfarin for therapeutic anticoagulation (concurrent mini-dose warfarin [1 mg orally per day] as prophylaxis allowed)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042952

Locations
United States, Illinois
Cancer and Leukemia Group B
Chicago, Illinois, United States, 60606
Sponsors and Collaborators
Investigators
Principal Investigator: Christopher Ryan Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00042952     History of Changes
Other Study ID Numbers: NCI-2012-02481, CLB-90105, U10CA031946, CDR0000069487
Study First Received: August 5, 2002
Last Updated: January 15, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Dysgerminoma
Germinoma
Neoplasms
Neoplasms, Germ Cell and Embryonal
Ovarian Neoplasms
Seminoma
Testicular Neoplasms
Adnexal Diseases
Endocrine Gland Neoplasms
Endocrine System Diseases
Genital Diseases, Female
Genital Diseases, Male
Genital Neoplasms, Female
Genital Neoplasms, Male
Gonadal Disorders
Neoplasms by Histologic Type
Neoplasms by Site
Ovarian Diseases
Testicular Diseases
Urogenital Neoplasms
Imatinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014