Perifosine in Treating Patients With Refractory Solid Tum... | NCT00019656 | Trialant
NCT00019656
Sponsor
National Cancer Institute (NCI)
Status
Completed
Last Update Posted
Apr 29, 2015Estimated
Enrollment
Not provided
Phase
Phase 1
Conditions
Leukemia
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Unspecified Adult Solid Tumor, Protocol Specific
Interventions
perifosine
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00019656
Obsolete or Duplicate NCT IDs
NCT00001799
Organization Study
CDR0000066960
Secondary IDs
ID
Type
Description
Link
NCI-99-C-0043
NCI-T98-0065
Brief Title
Perifosine in Treating Patients With Refractory Solid Tumors or Hematologic Cancer
Official Title
A Phase I Trial of Oral Perifosine With Different Loading Schedules in Patients With Refractory Neoplasms
Acronym
Not provided
Organization
National Cancer Institute (NCI)NIH
Status Module
Record Verification Date
Aug 2004
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 1999
Primary Completion Date
Not provided
Completion Date
Not provided
First Submitted Date
Jul 11, 2001
First Submission Date that Met QC Criteria
Jan 26, 2003
First Posted Date
Jan 27, 2003Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Apr 28, 2015
Last Update Posted Date
Apr 29, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Not provided
Lead Sponsor
National Cancer Institute (NCI)NIH
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have refractory solid tumors or hematologic cancer.
Detailed Description
OBJECTIVES:
Determine the dose-limiting toxicity and maximum tolerated dose of perifosine administered as a varying series of loading and maintenance doses in patients with refractory solid tumors, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma.
Determine the profile of adverse reactions (including changes in laboratory parameters) in patients treated with this regimen.
Determine any disease responses that may occur in patients treated with this regimen.
Determine the steady-state pharmacology and pharmacokinetics of this regimen in these patients.
OUTLINE: This is a dose-escalation study.
Patients receive a loading dose of oral perifosine on day 1 followed by a maintenance dose 2-3 times daily beginning on day 2 or 3 and continuing until day 21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
Cohorts of 3-6 patients receive escalating loading 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 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, an additional 10 patients are treated at that dose level.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A maximum of 45 patients will be accrued for this study within 12-18 months.
Conditions Module
Conditions
Leukemia
Lymphoma
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
stage IV chronic lymphocytic leukemia
refractory chronic lymphocytic leukemia
unspecified adult solid tumor, protocol specific
previously treated myelodysplastic syndromes
de novo myelodysplastic syndromes
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
Not provided
Arms/Interventions Module
Arm Groups
Not provided
Interventions
Name
Type
Description
Arm Group Labels
Other Names
perifosine
Drug
Outcomes Module
No data available
No data is available for this block.
Eligibility Module
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed solid tumor, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma that has no effective standard therapeutic option but requires systemic therapy
No history of CNS neoplasms
For prostate cancer:
Tumor progression during blockade of testicular and adrenal androgens
At least 4 weeks since prior flutamide or other antiandrogens without disease improvement
Leuprolide or other gonadotropin-releasing hormones should be maintained in patients without an orchiectomy
Testosterone in the castrate range
For breast cancer:
At least 4 weeks since any prior hormonal therapy with evidence of disease progression
PATIENT CHARACTERISTICS:
Age:
Over 18
Performance status:
ECOG 0-2
Life expectancy:
Not specified
Hematopoietic:
Platelet count greater than 50,000/mm^3
Absolute granulocyte count greater than 500/mm^3
Hemoglobin at least 9.0 g/dL
Hepatic:
Bilirubin no greater than 1.5 mg/dL
SGOT and SGPT no greater than 2.5 times normal
Renal:
Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min
Cardiovascular:
No history of unstable or newly diagnosed angina pectoris
No myocardial infarction within the past 6 months
No New York Heart Association class II-IV heart disease
Other:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
HIV negative
No recent acute or chronic gastrointestinal conditions (e.g., stomach ulcer or enteritis) that might affect tolerability or drug absorption
No allergic reaction to any medication with a structure similar to perifosine
No pre-existing retinal disease or pathologic baseline electrooculogram
No cataracts that would interfere with normal vision or require medical intervention
No other serious concurrent illness that would preclude assessment of drug effect
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
At least 2 months since prior UCN-01
More than 3 months since prior suramin
Endocrine therapy:
See Disease Characteristics
No concurrent corticosteroids except for physiological replacement or as antiemetics
Radiotherapy:
At least 4 weeks since prior radiotherapy (6 weeks for bone-seeking radioisotopes) and recovered
Surgery:
See Disease Characteristics
Other:
No other concurrent antineoplastic therapies
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Edward A. Sausville, MD, PhD
National Cancer Institute (NCI)
Study Chair
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda
Maryland
20892-1182
United States
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
Monga M, Messmann RA, Headlee D, et al.: A phase I trial of oral perifosine in patients with refractory neoplasms. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1837, 7b, 2002.
Result
Messmann RA, Headlee D, Woo EW, et al.: A phase I trial of oral perifosine with different loading and maintenance schedules in patients with refractory neoplasms. [Abstract] Proc Am Assoc Cancer Res 42: A-2880, 2001.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
recurrent mantle cell lymphoma
secondary myelodysplastic syndromes
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma