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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 completed.
First Received: August 5, 2002   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Cancer and Leukemia Group B
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00042952
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: 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 Cancer
Testicular Germ Cell Tumor
Drug: imatinib mesylate
Phase II

Study Type: Interventional
Study Design: 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):

Study Start Date: June 2002
Detailed Description:

OBJECTIVES:

  • 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.
  • Determine the toxicity of this drug in this patient population.
  • 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

DISEASE CHARACTERISTICS:

  • 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) OR
      • 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 OR
  • 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

PATIENT CHARACTERISTICS:

Age

  • 15 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL (transfusion allowed)

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT/SGPT no greater than 2.5 times ULN

Renal

  • Creatinine no greater than 1.5 times ULN

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy
  • No concurrent chemotherapy

Endocrine therapy

  • 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

Radiotherapy

  • 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

Surgery

  • Not specified

Other

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

  Show 82 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Christopher W. Ryan, MD University of Chicago
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069487, CLB-90105
Study First Received: August 5, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00042952     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent malignant testicular germ cell tumor
testicular seminoma
ovarian dysgerminoma
recurrent ovarian germ cell tumor
stage II malignant testicular germ cell tumor
stage III malignant testicular germ cell tumor
stage II ovarian germ cell tumor
stage III ovarian germ cell tumor

Study placed in the following topic categories:
Ovarian Neoplasms
Testicular Cancer
Gonadal Disorders
Genital Neoplasms, Female
Seminoma
Endocrine System Diseases
Urogenital Neoplasms
Testicular Neoplasms
Ovarian Diseases
Protein Kinase Inhibitors
Recurrence
Imatinib
Genital Diseases, Female
Dysgerminoma
Neoplasms, Germ Cell and Embryonal
Ovarian Cancer
Endocrinopathy
Endocrine Gland Neoplasms

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

ClinicalTrials.gov processed this record on July 02, 2009