Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00084812
Safingol and Cisplatin in Treating Patients With Locally Advanced or Metastatic Solid Tumors
A Phase 1 study testing cisplatin and safingol in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Safingol may stop the growth of tumor cells by blocking the enzymes necessary for their growth and 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?
- cisplatin and safingol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Feb 2009
- 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 tumor
- Locally advanced or metastatic disease
- Refractory to standard therapy OR not amenable to standard therapy
- No known CNS metastasis or CNS primary
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- At least 12 weeks
Hematopoietic
- Neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- WBC count ≥ 3,500/mm^3
- Hemoglobin ≥ 9.5 g/dL
- Haptoglobin ≥ 30 mg/dL
- No concurrent hemolysis or history of non-drug-induced hemolysis (e.g., spherocytosis)
Hepatic
- AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin ≤ 1.5 mg/dL
- PT and PTT normal
Renal
- Creatinine ≤ 1.5 mg/dL
Cardiovascular
- No cardiac arrhythmias
- No congestive heart failure
- No myocardial infarction within the past 6 months
Other
- Not pregnant
- Negative pregnancy test
- No nursing during and for at least 2 months after study participation
- Fertile patients must use effective contraception during and for at least 2 months after study participation
- HIV negative
- No mental incapacity that would preclude giving informed consent
- No moderate-to-severe high-frequency hearing loss
- No persistent severe (grade 2) drug-induced peripheral neuropathy
- No known allergy to cisplatin or any other platinum-containing compound
- No serious or uncontrolled infection
- No other medical condition or reason that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 4 weeks since prior immunotherapy
Chemotherapy
- Prior cisplatin allowed
- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin)
Endocrine therapy
- Not specified
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- Recovered from all prior therapy
- No concurrent vitamins, antioxidants, herbal preparations, or supplements
- Concurrent single tablet multivitamin allowed
- No other concurrent investigational medications
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: An Open-Labeled, Non-Randomized Phase I Study of Safingol Administered With Cisplatin in Patients With Advanced Solid Tumors
RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Safingol may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of safingol when given with cisplatin in treating patients with locally advanced or metastatic solid tumors.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of safingol when administered with cisplatin in patients with locally advanced or metastatic solid tumors.
Secondary
- Determine the toxic effects of this regimen in these patients.
- Determine the clinical pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the therapeutic activity of this regimen in these patients.
- Determine a safe dose (i.e., near the MTD) for phase II evaluation of this regimen in these patients.
- Determine, preliminarily, the role of ceramide and S1P, relative to response and apoptosis, in patients treated with this regimen.
OUTLINE: This is an open-label, non-randomized, dose-escalation study of safingol.
Patients receive safingol IV over 1 hour and cisplatin IV over 1 hour on day 1. Courses repeat every 21 days* in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive safingol on days 1 and 8 and cisplatin on day 8 for course 1 only; course 1 is 28 days in duration.
Cohorts of 3-6 patients receive escalating doses of safingol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose level.
- Being tested
- cisplatin, safingol
- 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.
cisplatinDrug
safingolDrug
| Study group | Role | What they receive |
|---|---|---|
| Safingol and Cisplatin | Experimental | Patients receive safingol IV over 1 hour and cisplatin IV over 1 hour on day 1. Courses repeat every 21 days* in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive safingol on days 1 and 8 and cisplatin on day 8 for course 1 only; course 1 is 28 days in duration.
Cohorts of 3-6 patients receive escalating doses of safingol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose level. Receives: Drug: cisplatin; Drug: safingol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended phase II dose as assessed by NCI toxicity scale during 3-4 weeks of treatment
Measured: 2 years
Secondary outcomes (1)
Response as assessed by RECIST criteria during 3-6 weeks of treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2004 (estimated)
- Study startMar 2004
- Primary completionFeb 2009
- Study completionFeb 2009
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.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Gary K. Schwartz, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterArchie N. Tse, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00084812
- Sponsor's protocol ID
- 04-002
- Other IDs
- MSKCC-04002
- Status last verified
- Mar 2013
- First submitted
- 10 Jun 2004
- Last updated
- 22 Mar 2013
- Results posted
- No
Publications
Dickson MA, Carvajal RD, Merrill AH Jr, Gonen M, Cane LM, Schwartz GK. A phase I clinical trial of safingol in combination with cisplatin in advanced solid tumors. Clin Cancer Res. 2011 Apr 15;17(8):2484-92. doi: 10.1158/1078-0432.CCR-10-2323. Epub 2011 Jan 21.
PubMed 21257722
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled, Non-Randomized Phase I Study of Safingol Administered With Cisplatin in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT00084812
- Acronym / sponsor ID
- 04-002
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 11 Jun 2004 (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: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Safingol may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of safingol when given with cisplatin in treating patients with locally advanced or metastatic solid tumors.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose (MTD) of safingol when administered with cisplatin in patients with locally advanced or metastatic solid tumors.
Secondary
- Determine the toxic effects of this regimen in these patients.
- Determine the clinical pharmacokinetics of this regimen in these patients.
- Determine, preliminarily, the therapeutic activity of this regimen in these patients.
- Determine a safe dose (i.e., near the MTD) for phase II evaluation of this regimen in these patients.
- Determine, preliminarily, the role of ceramide and S1P, relative to response and apoptosis, in patients treated with this regimen.
OUTLINE: This is an open-label, non-randomized, dose-escalation study of safingol.
Patients receive safingol IV over 1 hour and cisplatin IV over 1 hour on day 1. Courses repeat every 21 days* in the absence of disease progression or unacceptable toxicity.
NOTE: *Patients receive safingol on days 1 and 8 and cisplatin on day 8 for course 1 only; course 1 is 28 days in duration.
Cohorts of 3-6 patients receive escalating doses of safingol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose level.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safingol and Cisplatin | Experimental | Drug: cisplatin, Drug: safingolPatients receive safingol IV over 1 hour and cisplatin IV over 1 hour on day 1. Courses repeat every 21 days* in the absence of disease progression or unacceptable toxicity. NOTE: *Patients receive safingol on days 1 and 8 and cisplatin on day 8 for course 1 only; course 1 is 28 days in duration. Cohorts of 3-6 patients receive escalating doses of safingol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 10 additional patients are treated at that dose level. |
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 |
|---|---|---|
| cisplatin | Drug | Safingol and Cisplatin |
| safingol | Drug | Safingol and Cisplatin |
Primary outcome
Recommended phase II dose as assessed by NCI toxicity scale during 3-4 weeks of treatment
Time frame: 2 years
1 secondary outcome
Response as assessed by RECIST criteria during 3-6 weeks of treatment
Time frame: 2 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 22 Mar 2013.
- Results publication: PubMed 21257722Dickson MA, Carvajal RD, Merrill AH Jr, Gonen M, Cane LM, Schwartz GK. A phase I clinical trial of safingol in combination with cisplatin in advanced solid tumors. Clin Cancer Res. 2011 Apr 15;17(8):2484-92. doi: 10.1158/1078-0432.CCR-10-2323. Epub 2011 Jan 21.
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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.
Gary K. Schwartz, MD principal investigator
Memorial Sloan Kettering Cancer Center
Archie N. Tse, MD, PhD principal investigator
Memorial Sloan Kettering 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 cisplatin and safingol in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Memorial Sloan Kettering 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 22 Mar 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?
Recommended phase II dose as assessed by NCI toxicity scale during 3-4 weeks of treatment (time frame: 2 years). 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 NCT00084812, 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 22 Mar 2013.