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A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma


Phase 2
15 Years
N/A
Not Enrolling
Both
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

Thank you

Trial Information

A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma


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.


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)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate defined as either a complete or partial response using RECIST criteria

Outcome Description:

Response rate (CR+PR) and exact 95% confidence interval based on the binomial distribution for the response rate will be computed.

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Christopher Ryan

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02481

NCT ID:

NCT00042952

Start Date:

June 2002

Completion Date:

Related Keywords:

  • 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
  • Dysgerminoma
  • Seminoma
  • Testicular Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Germinoma
  • Ovarian Neoplasms

Name

Location

Cancer and Leukemia Group BChicago, Illinois  60606