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

NCT00042952 | Terminated Phase 2

• 4 other identifiers: NCI-2012-02481CLB-90105U10CA031946CDR0000069487
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

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

  Up to 2 years

Secondary Outcomes (5)

• Grade 1 or higher toxicities assessed using CTC)version 2

  Up to 2 years

• Duration of response

  From first response (CR or PR) to the date of disease progression or death, assessed up to 2 years

• Disease-free survival

  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

• Overall survival

  From date of initiation of treatment to date of death due to any cause, assessed up to 2 years

• Proportion of patients with mutations in the c-KIT gene

  Up to 2 years

Study Arms (1)

Treatment (imatinib mesylate and surgical resection)

EXPERIMENTAL

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; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis

Interventions

imatinib mesylate DRUG

Given orally

Also known as: CGP 57148, Gleevec, Glivec

Treatment (imatinib mesylate and surgical resection)

therapeutic conventional surgery PROCEDURE

Undergo surgical resection

Treatment (imatinib mesylate and surgical resection)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (imatinib mesylate and surgical resection)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

MeSH Terms

Conditions

Dysgerminoma; Testicular Neoplasms; Seminoma

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Germinoma; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Endocrine System Diseases; Testicular Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Christopher Ryan

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2002
• First Posted: January 27, 2003
• Study Start: June 1, 2002
• Primary Completion: October 1, 2003
• Last Updated: January 17, 2013

Record last verified: 2013-01

Locations

US (1)