Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00022113
EMD 121974 in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing cilengitide, pharmacological study and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Phase I trial to study the effectiveness of EMD 121974 in treating patients who have advanced solid tumors. EMD 121974 may slow the growth of solid tumors by stopping blood flow to the tumor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- cilengitide, pharmacological study and laboratory biomarker analysis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- May 2001to May 2005
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
- Tumors must be amenable to minimally-invasive biopsy (i.e., tumors must be superficial enough to be sampled by punch biopsy or core biopsy procedure without radiologic guidance)*
- No uncontrolled brain metastases, including symptomatic lesions or lesions requiring glucocorticoids and/or anticonvulsants to suppress symptoms
- Negative brain scan required if there are signs and symptoms suggestive of brain metastasis
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
Show all 39Show fewer
- At least 12 weeks
- WBC at least 3,000/mm^3
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 9 g/dL
- Bilirubin normal
- AST and ALT no greater than 2.5 times upper limit of normal
- Creatinine normal
- Creatinine clearance at least 60 mL/min
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No ongoing or active infection
- No other concurrent serious systemic disorders (e.g., significant CNS illness) that would preclude study
- No concurrent psychiatric illness or social situations that would preclude study
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other concurrent anticancer immunotherapy
- Concurrent hematologic growth factors for cytopenias allowed
- At least 4 weeks since prior anticancer chemotherapy (6 weeks for nitrosoureas, carmustine, or mitomycin) and recovered
- See Disease Characteristics
- No concurrent anticancer hormonal therapy
- Concurrent oral contraceptives or postmenopausal hormone replacement allowed
- Recovered from prior radiotherapy
- At least 2 weeks since prior palliative radiotherapy to bone or brain metastases
- At least 4 weeks since prior anticancer radiotherapy
- No concurrent anticancer radiotherapy
- Not specified
- At least 4 weeks since prior anticancer therapy and recovered
- At least 4 weeks since prior investigational agents
- Any number of prior therapies allowed
- No other concurrent anticancer investigational or commercial agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors
Phase I trial to study the effectiveness of EMD 121974 in treating patients who have advanced solid tumors. EMD 121974 may slow the growth of solid tumors by stopping blood flow to the tumor
Read the detailed description
OBJECTIVES:
- Determine the toxic effects and maximum tolerated dose of EMD 121974 in patients with advanced solid tumors.
II. Determine the biologic activity of this drug in these patients. III. Determine the pharmacokinetic profile and plasma biological effects of this drug and identify any relationship with its biologic activity or observed toxicity in these patients.
IV. Determine, preliminarily, the antitumor efficacy of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-10 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
- Being tested
- cilengitide, pharmacological study, laboratory biomarker analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cilengitideDrug
Also called EMD 121974
Given IV
Also called pharmacological studies
Correlative studies
laboratory biomarker analysisOther
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cilengitide) | Experimental | Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Receives: Drug: cilengitide; Other: pharmacological study; Other: laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD of cilengitide defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Graded according to the NCI Common Toxicity Criteria version 2.0.
Measured: 4 weeks
Toxic effects of cilengitide described as an adverse event that has an attribution of possibly, probably or definitely related to investigational treatment
Graded according to the NCI Common Toxicity Criteria version 2.0.
Measured: Up to 4 years
Biological activity of this regimen
Measured buy TUNEL assay, CD31 immunohistochemistry, dynamic contrast-enhanced MRI, and FDG-PET scan.
Measured: Up to 4 years
Secondary outcomes (3)
Pharmacokinetics of cilengitide
Measured: At 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 8.0, and 24.0 hours post-end-of-infusion on day 1 of course 1
Observation of response consisting of complete response, partial response, or stable disease, evaluated using the RECIST criteria
Measured: Up to 4 years
Time to progression
Measured: Up to 4 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 startMay 2001
- Primary completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Michele Basche, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022113
- Sponsor's protocol ID
- NCI-2012-02392
- Other IDs
- 00-1096, U01CA099176, CDR0000068786
- Status last verified
- Jan 2013
- First submitted
- 10 Aug 2001
- Last updated
- 25 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of EMD 121974 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00022113
- Acronym / sponsor ID
- NCI-2012-02392
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- May 2001
- Primary completion
- May 2005 (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.
Phase I trial to study the effectiveness of EMD 121974 in treating patients who have advanced solid tumors. EMD 121974 may slow the growth of solid tumors by stopping blood flow to the tumor
Detailed description
OBJECTIVES:
- Determine the toxic effects and maximum tolerated dose of EMD 121974 in patients with advanced solid tumors.
II. Determine the biologic activity of this drug in these patients. III. Determine the pharmacokinetic profile and plasma biological effects of this drug and identify any relationship with its biologic activity or observed toxicity in these patients.
IV. Determine, preliminarily, the antitumor efficacy of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-10 patients receive escalating doses of EMD 121974 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cilengitide) | Experimental | Drug: cilengitide, Other: pharmacological study, Other: laboratory biomarker analysisPatients receive EMD 121974 IV over 1 hour twice weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Histologically confirmed solid tumor that is refractory to standard therapy or for which no standard therapy exists
- Tumors must be amenable to minimally-invasive biopsy (i.e., tumors must be superficial enough to be sampled by punch biopsy or core biopsy procedure without radiologic guidance)*
- No uncontrolled brain metastases, including symptomatic lesions or lesions requiring glucocorticoids and/or anticonvulsants to suppress symptoms
- Performance status - ECOG 0-2
- Performance status - Karnofsky 60-100%
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 |
|---|---|---|
| cilengitideAlso: EMD 121974Given IV | Drug | Treatment (cilengitide) |
| pharmacological studyAlso: pharmacological studiesCorrelative studies | Other | Treatment (cilengitide) |
| laboratory biomarker analysisCorrelative studies | Other | Treatment (cilengitide) |
Primary outcome
MTD of cilengitide defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
Time frame: 4 weeks
Graded according to the NCI Common Toxicity Criteria version 2.0.
Toxic effects of cilengitide described as an adverse event that has an attribution of possibly, probably or definitely related to investigational treatment
Time frame: Up to 4 years
Graded according to the NCI Common Toxicity Criteria version 2.0.
Biological activity of this regimen
Time frame: Up to 4 years
Measured buy TUNEL assay, CD31 immunohistochemistry, dynamic contrast-enhanced MRI, and FDG-PET scan.
3 secondary outcomes
Pharmacokinetics of cilengitide
Time frame: At 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 8.0, and 24.0 hours post-end-of-infusion on day 1 of course 1
Observation of response consisting of complete response, partial response, or stable disease, evaluated using the RECIST criteria
Time frame: Up to 4 years
Time to progression
Time frame: Up to 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 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.
Michele Basche principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cilengitide, pharmacological study and laboratory biomarker analysis in people with Unspecified Adult Solid Tumor, Protocol Specific, 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 39 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: finished, as of the sponsor's last update on 25 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MTD of cilengitide defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. (time frame: 4 weeks). The study lists 3 primary outcomes in all. 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 25 Jan 2013.