Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00005794
Perifosine in Treating Patients With Advanced Solid Tumors
A Phase 1 study testing perifosine in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- perifosine
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2000to Jul 2003
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed locally unresectable or metastatic malignancy that is considered incurable
- Refractory to further treatment with known forms of effective therapy
- No clinically active CNS metastasis
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin normal
- SGOT no greater than 2.5 times upper limit of normal
Renal:
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 6 months after study participation
- Maintaining a reasonable state of nutrition consistent with weight maintenance
- No recent history of weight loss greater than 10% of current body weight
- No frequent vomiting/poor alimentation
- No other serious concurrent medical illness that would preclude study therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent immunotherapy
Chemotherapy:
- At least 4 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas) and recovered
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy
- Patients who have progressive disease while being treated with LHRH agonists, antiestrogens, or antitestosterones for at least 3 months may remain on these agents if in their best interest
Radiotherapy:
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 21 days since prior major surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
About this study
Official title: A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer
RATIONALE: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have advanced solid tumors.
Read the detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of perifosine on a loading dose/maintenance dose schedule in patients with advanced solid tumors.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Investigate the relationship between pharmacokinetic parameters and toxicity of this drug in these patients.
- Determine the recommended starting dose for phase II trials on this drug schedule in these patients.
- Evaluate the pharmacodynamic parameters on peripheral blood lymphocytes both before and during drug administration in these patients.
- Determine any changes in the MTD with prolonged administration (3 months, 6 months) of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive a loading dose of oral perifosine 4 times a day for 4-8 doses followed by a daily maintenance dose. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating loading doses and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxic effects.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
- Being tested
- perifosine
- 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.
perifosineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2003 (estimated)
- Study startFeb 2000
- Study completionJul 2003
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 University of Wisconsin, MadisonThe 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
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lynn Van Ummersen, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005794
- Sponsor's protocol ID
- 1999-355
- Other IDs
- P30CA014520, WCCC-CO-99906, ASTA-D-21266, NCI-T99-0036, CDR0000067752
- Status last verified
- Oct 2015
- First submitted
- 2 Jun 2000
- Last updated
- 13 Dec 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of Perifosine on a Loading Dose/Maintenance Dose Schedule in Patients With Advanced Cancer
- ClinicalTrials.gov ID
- NCT00005794
- Acronym / sponsor ID
- 1999-355
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2000
- Study completion
- Jul 2003 (actual)
- First posted
- 8 Oct 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: Perifosine may stop the growth of tumor cells by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES:
- Determine the maximum tolerated dose (MTD) of perifosine on a loading dose/maintenance dose schedule in patients with advanced solid tumors.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the pharmacokinetics of this drug in these patients.
- Investigate the relationship between pharmacokinetic parameters and toxicity of this drug in these patients.
- Determine the recommended starting dose for phase II trials on this drug schedule in these patients.
- Evaluate the pharmacodynamic parameters on peripheral blood lymphocytes both before and during drug administration in these patients.
- Determine any changes in the MTD with prolonged administration (3 months, 6 months) of this drug in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive a loading dose of oral perifosine 4 times a day for 4-8 doses followed by a daily maintenance dose. Treatment continues every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating loading doses and maintenance doses of perifosine until the maximum tolerated dose (MTD) of each is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxic effects.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| perifosine | Drug | – |
Primary outcome
Not reported in the source record.
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 13 Dec 2019.
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.
Lynn Van Ummersen, MD study chair
University of Wisconsin, Madison
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 perifosine in people with Unspecified Adult Solid Tumor, Protocol Specific, run by University of Wisconsin, Madison 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 13 Dec 2019. 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.
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 13 Dec 2019.