Ovarian DysgerminomaPhase 2NCT00042952
Imatinib Mesylate in Treating Patients With Progressive, Refractory, or Recurrent Stage II or Stage III Testicular or Ovarian Cancer
A Phase 2 study testing imatinib mesylate, therapeutic conventional surgery and laboratory biomarker analysis in people with Ovarian Dysgerminoma and Recurrent Malignant Testicular Germ Cell Tumor, run by National Cancer Institute (NCI) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Ovarian Dysgerminoma, Recurrent Malignant Testicular Germ Cell Tumor, Recurrent Ovarian Germ Cell Tumor
- What is being tested?
- imatinib mesylate, therapeutic conventional surgery and laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to Oct 2003
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 47Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer and Leukemia Group B
Chicago, Illinois, 60606
About this study
Official title: A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma
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
Read the 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.
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.
- 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
- Being tested
- imatinib mesylate, therapeutic conventional surgery, laboratory biomarker analysis
- Medical subject headings
- Dysgerminoma, Testicular Neoplasms, Seminoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imatinib mesylateDrug
Also called CGP 57148, Gleevec, Glivec
Given orally
therapeutic conventional surgeryProcedure or surgery
Undergo surgical resection
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: imatinib mesylate; Procedure: therapeutic conventional surgery; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (5)
Grade 1 or higher toxicities assessed using CTC)version 2
Toxicities will be tabulated.
Measured: Up to 2 years
Duration of response
The Kaplan-Meier product-limit method will be used.
Measured: From first response (CR or PR) to the date of disease progression or death, assessed up to 2 years
Disease-free survival
The Kaplan-Meier product-limit method will be used.
Measured: 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
The Kaplan-Meier product-limit method will be used.
Measured: 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
The 95% confidence interval will be estimated.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startJun 2002
- Primary completionOct 2003
Why it stopped: Administratively complete.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian DysgerminomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Christopher Ryan, Principal investigator, Cancer and Leukemia Group B
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00042952
- Sponsor's protocol ID
- NCI-2012-02481
- Other IDs
- CLB-90105, U10CA031946, CDR0000069487
- Status last verified
- Jan 2013
- First submitted
- 5 Aug 2002
- Last updated
- 17 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study Of Imatinib Mesylate (Gleevec, Formerly Known As STI571; IND 61,135, NSC #716051) In Patients With Refractory Seminoma
- ClinicalTrials.gov ID
- NCT00042952
- Acronym / sponsor ID
- NCI-2012-02481
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administratively complete.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 2002
- Primary completion
- Oct 2003 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (imatinib mesylate and surgical resection) | Experimental | Drug: imatinib mesylate, Procedure: therapeutic conventional surgery, Other: laboratory biomarker analysisPatients 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (47 listed)
- Histologically confirmed pure testicular seminoma or ovarian germ cell dysgerminoma
- 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:
- Cisplatin-refractory disease without option of potentially curative therapy, meeting 1 of the following criteria:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imatinib mesylateAlso: CGP 57148, Gleevec, GlivecGiven orally | Drug | Treatment (imatinib mesylate and surgical resection) |
| therapeutic conventional surgeryUndergo surgical resection | Procedure or surgery | Treatment (imatinib mesylate and surgical resection) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (imatinib mesylate and surgical resection) |
Primary outcome
Response rate defined as either a complete or partial response using RECIST criteria
Time frame: Up to 2 years
Response rate (CR+PR) and exact 95% confidence interval based on the binomial distribution for the response rate will be computed.
5 secondary outcomes
Grade 1 or higher toxicities assessed using CTC)version 2
Time frame: Up to 2 years
Duration of response
Time frame: From first response (CR or PR) to the date of disease progression or death, assessed up to 2 years
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
Overall survival
Time frame: 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
Time frame: Up to 2 years
Results and safety
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Ryan principal investigator
Cancer and Leukemia Group B
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing imatinib mesylate, therapeutic conventional surgery and laboratory biomarker analysis in people with Ovarian Dysgerminoma and Recurrent Malignant Testicular Germ Cell Tumor, run by National Cancer Institute (NCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 47 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate defined as either a complete or partial response using RECIST criteria (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.