Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00005642
SU5416 in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing semaxanib in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have advanced solid tumors. 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?
- semaxanib
- Type of treatment
- Injection or infusion
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- May 2000to Nov 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
DISEASE CHARACTERISTICS: Histologically confirmed solid tumors not amenable to conventional therapy At least 2 distinct lesions of metastatic or primary tumor of at least 1-2 cm OR Single lesion if large enough for both biopsy and MRI flow studies No brain metastases or primary brain tumors
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin greater than 9.0 g/dL Hepatic: Bilirubin normal PT normal OR INR less than 1.1 PTT normal Renal: Creatinine less than 1.5 mg/dL AND/OR Creatinine clearance greater than 60 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease No uncompensated coronary artery disease on electrocardiogram or physical exam No myocardial infarction or severe or unstable angina within the past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep vein thrombosis or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy and recovered Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: At least 3 weeks since prior hormonal therapy and recovered Radiotherapy: At least 4 weeks since prior large field radiotherapy and recovered Surgery: Not specified
Trial locations and contacts
1 site in 1 country.
United States1 site
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: A Phase I Pharmacodynamic Trial of SU5416 (NSC 696819)
RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES: I. Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors. II. Determine the relationship between dose or plasma levels and the clinical safety profile and antitumor effects of this treatment regimen in terms of objective response, stabilization of disease, or progression-free survival in this patient population. III. Evaluate the relationship between dose or plasma levels of SU5416 concentrations and the ability of this treatment regimen to reduce microvessel density and induce apoptosis of endothelial and tumor cells in this patient population. IV. Determine prognostic and surrogate serologic markers in these patients treated with this regimen. V. Determine if pre and posttreatment plasma and serum levels of angiogenic growth factors, basic fibroblast growth factor, and vascular endothelial cell growth factor are prognostic in predicting patient response to this regimen. VI. Determine if elevated plasma levels of endothelial cell specific proteins reflective of SU5416-induced endothelial damage and/or apoptosis are useful surrogate markers in assessing response to this treatment regimen in these patients.
OUTLINE: This is a dose-deescalation study. Patients receive SU5416 IV over 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 6-12 patients receive deescalating doses of SU5416 until the maximum target-inhibiting dose (MTID) is determined. The MTID is defined as the dose at which patients experience no greater than grade 1 toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
- Being tested
- semaxanib
- Keywords
- unspecified adult solid tumor, protocol specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaxanibDrug
Also called semoxind, SU5416, Sugen 5416
This is a dose-deescalation study. Patients receive SU5416 IV over 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 6-12 patients receive deescalating doses of SU5416 until the maximum target-inhibiting dose (MTID) is determined.
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors.
Measured: 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients followed every 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2003 (estimated)
- Study startMay 2000
- Primary completionDec 2002
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Afshin Dowlati, MD, Principal investigator, Ireland Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005642
- Sponsor's protocol ID
- CWRU2Y99
- Other IDs
- U01CA062502, P30CA043703, CWRU-2Y99, NCI-T99-0095
- Status last verified
- Jun 2010
- First submitted
- 2 May 2000
- Last updated
- 11 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stopeck A, Sheldon M, Vahedian M, Cropp G, Gosalia R, Hannah A. Results of a Phase I dose-escalating study of the antiangiogenic agent, SU5416, in patients with advanced malignancies. Clin Cancer Res. 2002 Sep;8(9):2798-805.
PubMed 12231519
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Pharmacodynamic Trial of SU5416 (NSC 696819)
- ClinicalTrials.gov ID
- NCT00005642
- Acronym / sponsor ID
- CWRU2Y99
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2000
- Primary completion
- Dec 2002 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 17 Dec 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.
RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES: I. Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors. II. Determine the relationship between dose or plasma levels and the clinical safety profile and antitumor effects of this treatment regimen in terms of objective response, stabilization of disease, or progression-free survival in this patient population. III. Evaluate the relationship between dose or plasma levels of SU5416 concentrations and the ability of this treatment regimen to reduce microvessel density and induce apoptosis of endothelial and tumor cells in this patient population. IV. Determine prognostic and surrogate serologic markers in these patients treated with this regimen. V. Determine if pre and posttreatment plasma and serum levels of angiogenic growth factors, basic fibroblast growth factor, and vascular endothelial cell growth factor are prognostic in predicting patient response to this regimen. VI. Determine if elevated plasma levels of endothelial cell specific proteins reflective of SU5416-induced endothelial damage and/or apoptosis are useful surrogate markers in assessing response to this treatment regimen in these patients.
OUTLINE: This is a dose-deescalation study. Patients receive SU5416 IV over 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 6-12 patients receive deescalating doses of SU5416 until the maximum target-inhibiting dose (MTID) is determined. The MTID is defined as the dose at which patients experience no greater than grade 1 toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| semaxanibAlso: semoxind, SU5416, Sugen 5416This is a dose-deescalation study. Patients receive SU5416 IV over 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 6-12 patients receive deescalating doses of SU5416 until the maximum target-inhibiting dose (MTID) is determined. | Drug | – |
Primary outcome
Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors.
Time frame: 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients followed every 3 months.
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 11 Jun 2010.
- Results publication: PubMed 12231519Stopeck A, Sheldon M, Vahedian M, Cropp G, Gosalia R, Hannah A. Results of a Phase I dose-escalating study of the antiangiogenic agent, SU5416, in patients with advanced malignancies. Clin Cancer Res. 2002 Sep;8(9):2798-805.
Related trials for Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruitingPhase 1
RNR Inhibitor COH29 in Treating Patients With Solid Tumors That Are Refractory to Standard Therapy or For Which No Standard Therapy Exists
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
Assessment Tool for Older Patients With Cancer
Cognitive/Functional Effects, Psychosocial Effects of Cancer and Its Treatment
Active, not recruiting
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
Breast Cancer, Colon Cancer
Recruiting
Copenhagen Prospective Personalized Oncology (CoPPO)
Unspecified Adult Solid Tumor, Protocol Specific
Active, not recruiting
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
Brain and Central Nervous System Tumors, Chronic Myeloproliferative Disorders
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.
Afshin Dowlati, MD principal investigator
Ireland Cancer Center
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 semaxanib in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center 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?
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 11 Jun 2010. 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?
Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors. (time frame: 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients followed every 3 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00005642, which also lists 1 linked publication.
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 11 Jun 2010.